Specialist Senior Analyst - QC support
Jobbeschreibung
Couvet, Neuenburg, Schweiz
WuXi AppTec
03.05.2024
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OverviewJob Summary:This position is responsible to perform all Super
User activities for the laboratory computerized systems. This includes
at least Audit Trail Reviews and Master Data Management, optimization
and/or new method setup, in adherence with data integrity principles
as well as end user training, on-the-job training and equipment
troubleshooting.Additional responsibilities are selection,
acquisition, and qualification of new analytical equipment by
handling, writing and executing Change Control, User Requirement
Specification and Performance Qualification protocol. Owns deviations,
leads or supports laboratory investigations associated with equipment
issues.As a QC Team Member, the person filling this position supports
all activities to continuously maintain the GMP status of the QC
Laboratory.As a Senior QC Team Member this position acts as a centre
of competence reflecting experience, transferring knowledge and
supporting other QC team members in all aspects of their daily
work.ResponsibilitiesEssential Job Functions: Super User of Laboratory
computerized systems.Performs Audit trail review.Manages Master data
for Laboratory software (e.g. Empower, Dissolution Workstation, Tiamo,
etc.).Assures adherence to data integrity principles.Uses technical
expertise to investigate and resolve technical issues in the
laboratoryTakes responsibility in selection, purchase and
commissioning of new equipmentOwns the change control, deviation and
CAPA, leads or supports risk assessmentsEvaluates impact of compendial
changes on applicable QC procedures and opens change controls as
requiredWrites and reviews all types of GMP documents (e.g. SOP, TWI,
URS, PQ, test method, validation protocols and reports, investigation
reports etc).Supports internal and external auditsQC representative in
transversal projectMaintains the GMP status of the laboratoryIn charge
of the support of QC team members (“centre of competencies”)· Supports
maintenance/calibration of equipment and keeps relationship with
suppliers· Can be assigned special duties and
tasksQualificationsExperience / EducationFederal Certificate of
Capacity as Laboratory Technician or similar educationMinimum 5 years
of work experience in a GMP environmentKnowledge / Skills /
Abilities:Excellent knowledge in HPLC and GC techniques and
CDS.Excellent knowledge of dissolution, UV/VIS and IR
techniques.Knowledge of analytical method transfer and analytical
method validation.Experience of doing analytical testing according to
Ph. Eur. and USP prescriptions.Experience in laboratory equipment
qualification.Very good communication skills.Very good writing
skills.Excellent team spirit.Very good knowledge in English and
French.Very good knowledge of most common office software.Good
knowledge and/or ability to familiarize themselves quickly with new
software and computerized systems (specific instrument software,
LIMS).Capability for know-how transfer to and training of other QC
team members.An Equal Opportunity Employer. All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, or protected veteran status and will not be discriminated
against on the basis of disabilityThis job description does not state
or imply that the above are the only duties and responsibilities
assigned to this position. Employees holding this position will be
required to perform any other job-related duties as requested by
Management.Job SummaryJob ID: 2024-12520
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Specialist Senior Analyst - QC Support
WuXi AppTec
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