Specialist Senior Analyst - QC support
Jobbeschreibung
Travers, Neuenburg, Schweiz
WuXi AppTec
20.05.2024
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Job 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.
Essential 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
laboratory Takes responsibility in selection, purchase and
commissioning of new equipment Owns the change control, deviation and
CAPA, leads or supports risk assessments Evaluates impact of
compendial changes on applicable QC procedures and opens change
controls as required Writes 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
audits QC representative in transversal project Maintains the GMP
status of the laboratory In 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 tasks Experience / Education Federal Certificate of
Capacity as Laboratory Technician or similar education Minimum 5 years
of work experience in a GMP environment Knowledge / 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 disability This 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.
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Specialist Senior Analyst - QC Support
WuXi AppTec
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