18 Jobs für Mitarbeiter Qa in Schweiz

Manpower

Experis is the global leader in professional resourcing and project-based workforce solutions.
Services:
The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of implementation of a new Fill and Finishing and Visual Inspection area. He/she could also be involve in routine GMP operations for Fill and Finishing area. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.

This resource will be specifically responsible for the following tasks:

• Prepare, evaluate, and approve controlled documentation, creation/revision.
• Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.
• Attend all meetings relevant to perform the above-mentioned tasks.
• Respect the escalation process.
• Ensure completion of relevant training and software access management according to Takeda policies.
• Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, batch review, etc.).

The above-mentioned tasks are site-based and on-site presence is expected.
Home office might be allowed occasionally for specific tasks upon request.
  Education

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Master's degree or equivalent (Bac+5) in a scientific or technical field ? specialization in biotechnology, process engineering, or pharmaceutical quality.

Professional Experience

• 2 to 3 years of hands-on experience in a GMP-regulated environment, ideally within a Quality Operations department on a sterile injectable pharmaceutical manufacturing site.

• Work experience in classified cleanrooms, knowledge of EU/US GMP requirements, and strong understanding of aseptic filling processes.

Technical Skills

• Holistic understanding of production processes:
  → Cell culture, fermentation, purification, formulation, aseptic filling.
  → Familiarity with environmental monitoring, gowning procedures, microbiological and particle monitoring.
  → Understanding of QC testing ? both physicochemical and biological.

• Proficient with Quality Systems:
  → Deviations, CAPA, Change Control, Training, Documentation.
  → Active participation in internal and external audits.

 Languages

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Fluent in French and English (written and spoken).

Digital Skills

• Proficient in PC use and the Microsoft Office suite (Word, Excel, PowerPoint, Outlook).

Soft Skills

• Strong teamwork abilities.

• Agile, autonomous, and adaptable in a dynamic environment.

If this job interests you please do send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar  at

Branche: Pharma-Industrie

Funktion: Personalwesen

**Abbott** is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott Established Pharmaceutical Division **(EPD)** is looking for a
**Specialist Global Distribution QA**
for its global Pharma Division Headquarter based in Allschwil- Basel.
(This is a **fixed-term, one-year assignment** offered **via a third-party vendor** .)
Are you passionate about quality and compliance in pharmaceutical distribution? Do you thrive in a dynamic, cross-functional environment? If so, this role could be your next career move!
**What You'll Do:**
As a key member of our Quality team, you'll ensure our Allschwil site maintains its Pharmaceutical License and GDP authorization, while supporting the safe and compliant distribution of medicinal products, nutritional items, cosmetics, and medical devices across global markets.
Your responsibilities will include:
+ Maintaining and improving the site's **Quality System** (training, documentation, change control, deviations, audits)
+ Managing **complaints, returns** , and supporting **market actions**
+ Qualifying and monitoring **logistics and distribution partners**
+ Ensuring **customer verification** and maintaining the **Approved Supplier List**
+ Providing QA input into **global distribution projects** , including:
+ Counterfeit prevention
+ Temperature monitoring and excursion management
+ Product transportation optimization
+ Serialization and aggregation
+ Supply chain validation
+ Material listing approvals
You'll collaborate closely with teams across **Supply Chain, Global QA, Master Data, and Product Protection** to ensure compliance with GxP standards.
**What You Bring:**
+ A degree in **Pharmacy, Chemistry, Biology, Microbiology, Engineering** , or a related scientific field
+ At least **1 year of experience** in QA or operations within a pharmaceutical setting
+ Solid understanding of **EU GMP/GDP** and international standards (PIC/S, WHO, ICH)
+ Strong problem-solving and communication skills
+ A collaborative mindset and ability to work cross-functionally
+ Fluent **English** (additional languages are a plus)
+ Willingness to travel within Europe (approx. 10%)
**Why Join Us?**
At Abbott, you'll be part of a global team that's committed to improving lives through innovation and quality. You'll work in a supportive, fast-paced environment where your contributions truly matter.
If this sounds like the right opportunity for you, we'd love to hear from you. Please submit your CV (PDF format preferred). We welcome applicants from all backgrounds and are committed to building a diverse and inclusive team.
(If you want to upload several documents, don`t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed, Office
**Job Description**
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. And with over $1 billion invested annually in R&D, we empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.
**Position Purpose**
This is a remarkable opportunity to join Thermo Fisher Scientific Inc. as a Supervisor QA Systems & Compliance. In this role, you will oversee and supervise compliance activities within our Lengnau site, ensuring our processes meet the highest standards of quality and reliability. You will interact with varying levels of staff within the organization, as well as customers and auditors, to strictly determine and successfully implement outstanding compliance processes.
**Key Responsibilities**
+ Coordinate and supervise compliance activities within the Lengnau site.
+ Make critical decisions regarding process compliance to impact product quality.
+ Coordinate or lead QA activities including quality agreements, metrics, self-inspection, inspection readiness programs, supplier qualification, auditing, record review, final product functions, complaints, document management, risk management, and oversight of quality systems and investigations within QA.
+ Manage the lifecycle of associated concepts/programs, policies, and procedures.
**Education**
+ A Master's degree in a life science field is required. Equivalent work experience and knowledge can substitute.
**Experience & Proficiencies**
+ More than 10 years of proven experience in the pharmaceutical industry.
+ Excellent knowledge of Operations and Quality Assurance for biological pharmaceuticals (cGMP) with over 5 years of experience.
+ In-depth knowledge of Quality practices, cGMP regulations, and international health authority guidelines (especially Swissmedic and US FDA).
**Additional Requirements**
+ On-call services (picket light / 2nd level remote), based on department organization.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.
-Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization.
-Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy.
-Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
-Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not.
-Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns.
-Communicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities.
-Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries.
-Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions.
-Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
.
Qualifications
-Bachelor's Degree in relevant Life Science or other technical discipline or equivalent job experience required.
-7+ years of total combined experience. At least 5 years in Quality Assurance Operations Management; 3 years in Operations, Research and Development or Consulting.
-Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
-Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Ihre AufgabenSelbstständige Bearbeitung von Kundenprojekten im Bereich QA/QM/RABeratung und operative Unterstützung zu Gx P-ThemenAufbau und Optimierung von Gx P-QualitätssystemenBegleitung von Inspektionen und Durchführung von AuditsBeratung zu Consumer Health ProduktenUnterstützung bei AbgrenzungsfragenBearbeiten und Einreichen von ZulassungsgesuchenLife Cycle Management (Variations, Renewals)Mithilfe beim Ausbau und Weiterentwicklung der DienstleistungenIhr ProfilNaturwissenschaftlicher Abschluss (Pharmazie, Chemie, Biotechnologie) oder vergleichbarSchnelle Einarbeitung in verschiedene AufgabenbereicheMehrjährige Erfahrung in der Life Sciences Industrie im GMP/GDP regulierten UmfeldMehrjährige Tätigkeit im Bereich QA und ZulassungenGute Kenntnisse der Schweizer RegularienErfahrung im Consumer Health Bereich wünschenswertSelbstständige, lösungsorientierte ArbeitsweiseSicheres Auftreten, Team- und KommunikationsfähigkeitSehr gute Deutsch- und EnglischkenntnisseUnser AngebotSpannende und abwechslungsreiche ProjekteEin kollegiales Team und einen unterstützenden PatenFlexibles Orts- und ArbeitszeitmodellUnbefristete ArbeitsverträgeInterne und externe WeiterbildungsmöglichkeitenOffene Unternehmenskultur mit kurzen Entscheidungswegen jid4dffe82je jit0938je jiy25je

We are looking for a 

Sr Scientist QA Operation

Position Responsibilities & Accountabilities

Technical Responsibilities

·    During Project Phase: Implementation of Manufacturing Execution System (MES) with regards to QM processes, including 'Review by Exception RbE' concept during the project phase

·    Implementation and Maintenance of Quality processes for Review / Approval of master batch records/ executed batch records including writing of relevant procedures during the project phase.

·    Review and release of purchased materials, internally manufactured materials including buffer/media assemblies, intermediates and drug substance including writing of relevant procedures during the project phase.

·    Review and approval of operational elements such as procedures and related documents including specifications

·    Assist with continuous improvement initiatives related to quality documents and processes.

·    Supervision of the preparation of the Annual Product Review (APQR) and guarantees its execution within the due date.

Quality

·    Adheres to general cGMP rules, Quality policies, porcedures and instruction as rolled out by the Quality function and endorsed by the site management.

·    Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.

EHSS

·    Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.

·    Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.

Values and behaviour

·    Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.

·    Takes personal accountability for his/her presence, performance, and productivity for the achievements of defined objectives.

·    Thinks and acts with a customer-centric mindset.

·    Is intellectually curious and embraces Practical Process Improvement (PPI).

Position Qualifications

Education

·    Pharmacist, Chemist / Biologist / Microbiologist / Biochemist or Immunolgist with master degree or higher.

Experience & Competencies

·    3-5 years in pharmaceutical industry (biotech company) and not less than 1 year in commercial batch release

·    Knowledge of pharmaceutical manufacturing processes with particular focus on biologic drug substance

·    Fluent communication (oral and written) in German and English.

·    Experience in SAP and electronic MES (manufacturing execution system) is an asset

Please send your full application documents to

Branche: Pharma-Industrie

Funktion: Qualitätsprüfung

Führungsperson: Nein

Anstellungsart: Festanstellung

Karrierestufe: Management

CSL Behring ist ein weltweit führendes Biotech-Unternehmen, das sich seinem Versprechen verpflichtet hat, Leben zu retten. In Bern entwickeln und vertreiben wir mit über 1600 Mitarbeitenden lebensrettende Therapien für Menschen mit schweren und seltenen Krankheiten weltweit.

Für unseren Standort Bern , suchen wir per sofort oder nach Vereinbarung eine:n

Quality Professional QA Visual Inspection (80%)
 

Kompetenzen und Verantwortlichkeit

• Visuelle Stichprobenkontrolle unserer Halbfabrikate (AQL)    
• Überprüfen und Sicherstellen der Einhaltung der GMP Anforderungen in der Produktion
• Kontrolle, Überprüfung und Dokumentation von Arbeitsschritten, Review von Prozessen in der Produktion
• Dokumentenreview (Chargen-Dokumentationen)
• Chargenfreigabe in SAP
• Qualifizierung der Teststs der visuellen Kontrolle
• Mitarbeit bei der Schulung und (Re)-Qualifizierung von Mitarbeitern in der visuellen Kontrolle
• Unterstützung der Produktion bei Problemen bezüglich guter Herstellpraxis (GMP) während der gesamten Herstelldauer

Qualifikationen & Berufserfahrung

• Eine abgeschlossene Berufsausbildung, idealerweise im Labor-,Pharma- oder Lebensmittelbereich
• GMP Erfahrung oder Kenntnisse aus der pharmazeutischen Industrie von Vorteil
• Gute PC-Kenntnisse (MS-Office, vorzugsweise SAP)
• sehr exakte, und zuverlässige Arbeitsweise
• flexible Persönlichkeit und die Fähigkeit, sich rasch in neue Situationen einzudenken
• Teamorientiertes Denken, Kommunikationsstärke und die Fähigkeit auf Menschen aller Hierarchiestufen zuzugehen
• hohes Mass an Selbständigkeit und Eigeninitiative
• Sehr gute Kenntnisse in Deutsch, schriftlich und mündlich

Über diese Position:

• Nach der Einarbeitung in regelmässigen Abständen früh-(06:00-15:30) und Abendschicht (14:30-23:30) Arbeitsort Bolligenstrasse 93, 3006 Bern und Wankdorfsstr. 10, 3014 Bern

Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung. Ihre Bewerbung sollte ein Motivationsschreiben, einen Lebenslauf/CV sowie Arbeitszeugnisse und Kopien von Diplomen in der Originalsprache und/oder relevante Transkripte beinhalten. Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma . Our parent company, CSL , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL .

Do work that matters at CSL Behring!

  Unser KundeUnser Kunde ist eine führende und anerkannte Dienstleisterin in der chemisch-pharmazeutischen Industrie mit rund 100 Mitarbeitenden. Das inhabergeführte Unternehmen hat sich auf die Entwicklung und Produktion von Wirkstoffen und Endprodukten spezialisiert und produziert und verpackt mit einem modernen Maschinenpark vorwiegend Tabletten und Kapseln. Arbeitsort: Region Basel Ihr AufgabenbereichAnsprechpartner für qualitätsbezogene Fragen im Rahmen interner und externer Projekte.Erstellen, ändern und freigeben von Herstellvorschriften und Herstelldokumentationen frei (SOPs, Change, Control, Batch Record Reviews).Sie bearbeiten Abweichungen, Reklamationen sowie CAPAs und GMP-Dokumente.Sie pflegen und optimieren das Qualitätsmanagementsystem.Erstellen der jährlichen Product Quality Reviews (PQR).Vorbereiten von Kunden- und Behördenaudits sowie InspektionenIhr ProfilAbgeschlossenes Studium (Uni, FH) in Chemie, Pharmazie oder ähnliches Erste Erfahrung in der Qualitätssicherung innerhalb eines chemisch-/pharmazeutischen UmfeldsFundiertes GMP-Know-how.Strukturierte und selbstständige Persönlichkeit mit exakter und zuverlässiger ArbeitsweiseFliessende Deutsch- und Englischkenntnisse in Wort und SchriftIhre VorteileAbwechslungsreiche und vielseitige AufgabenFlache Hierarchien, kurze Entscheidungswege und MitbestimmungsmöglichkeitenEin wachsendes Unternehmen, mit soliden Strukturen und Prozessen  jid47b5022je jit0938je jiy25je

  Unser KundeUnser Kunde, die Bardusch AG, ist ein führendes Unternehmen im Bereich Textilmanagement mit einem hohen Qualitätsanspruch – insbesondere für Kunden aus der pharmazeutischen und biotechnologischen Industrie. In modernen Anlagen und unter Reinraumbedingungen werden hochspezialisierte Dienstleistungen wie die Aufbereitung, Kontrolle und Lieferung von Reinraumtextilien angeboten. Um den steigenden Anforderungen im GMP-regulierten Umfeld auch künftig gerecht zu werden, wird der Bereich Qualitätssicherung gezielt weiter verstärkt.Arbeitsort: Region Solothurn Ihr VerantwortungsbereichVerantwortung für die Validierung und Qualifizierung von Reinräumen, Maschinenparks sowie ProduktionsprozessenPlanung, Durchführung, Dokumentation und Freigabe von DQ, IQ, OQ und PQ – unter Einhaltung geltender GMP- und ISO-VorschriftenOrganisation und Umsetzung von Reinraumqualifizierungen, inklusive Überwachung relevanter Umgebungsparameter (z.  B. Temperatur, Luftfeuchtigkeit, Partikelzahlen) in Zusammenarbeit mit externen PartnernSicherstellung und kontinuierliche Weiterentwicklung der Qualitäts- und Compliance-Standards im ReinraumkontextErstellung, Pflege und Schulung von SOPs (Standard Operating Procedures) für alle relevanten Prozesse im ReinraumUnterstützen bei CAPAs, Change Control und DeviationsBearbeitung von Kundenreklamationen sowie Vorbereitung und Begleitung interner und externer AuditsIhr ProfilAbgeschlossene Lehre als Laborant/in (Biologie, Chemie) oder naturwissenschaftliches StudiumErfahrung im Bereich Validierung und Qualifizierung, z. B. Laborgeräte (Instrumente, Waschmaschinen, Waagen, Kühlschränke) oder Prozessanlagen (DQ, IQ, OQ, PQ)Gute Kenntnisse der relevanten GMP und ISO-NormenErfahrung in der Qualitätssicherung mit CAPA, Changes, Deviations und ComplaintsErfahrung in der Durchführung von Prozessvalidierungen und der Erstellung entsprechender Dokumentationen von VorteilEigenständige Persönlichkeit, mit exakter, strukturierter und Organisierter ArbeitsweiseGute Kommunikationsfähigkeiten und eine Prise HumorSehr gute Deutsch- und Englischkenntnisse in Wort- und Schrift. Französisch ist ein grosses PlusIhre VorteileEine vielseitige und abwechslungsreiche Stelle in einem hochmodernen und wachsenden BereichFinanzielle Unterstützung bei Weiterbildungen und SchulungenGute Karriereaussichten und die Möglichkeit, weiterführende Verantwortung zu übernehmen    jid5e2f3dfje jit0938je jiy25je