Our customer, a leading international pharmaceutical company with headquarters in Basel, is looking for a motivated
Associate Quality Manager
You will support the supervisor in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions. Furthermore, you will support departmental projects and objectives according to agreed timelines and standards in the given area of competency and supports adherence to compliance with GMP in the Technical Research and Development department.
Your main tasks:
- Perform review of GMP relevant documents for compliance with SOPs across several customer groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.)
- Perform review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, GLIMS specifications)
- Supervise 0-3 direct/indirect reports or a team
- Negotiate deficiencies in GMP documents with the line unit
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
- Act as contact person for QA questions of quality relevant electronic systems (e.g. IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore), and/or as a contact person to the needs of the line unit (e.g. CoA needs from different customers; TEDI formats, etc.).
- Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, CoCs, BRR sheets, test scripts, SOPs with extended applicability).
- Perform statistical interpretation of trending data collected by QA (e.g. in TQW or audit database). Compile trending reports and suggest conclusions.
- Collaborate with other associates to support the service function of QA
- Evaluate new QA tools (e.g. IT systems, processes)
- Participate in knowledge exchange within and outside of TRD
- Participate in training and coaching of new and temporary employees in QA and from associated line functions
- Lead and support direct reports in line with company internal values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.
- Apprenticeship or Bachelor degree in a scientific area (e.g. pharmacy, chemistry, biology)
- Several years of experience in a pharmaceutical company (e.g. in the laboratory, manufacturing, packaging)
- Very good knowledge of GMP
- Negotiation and communication skills to address GMP related questions with the line unit experts, in order to maintain GMP records in a compliant status
- Good knowledge of drug development
- Good organizational skills and proven ability to analyze and evaluate GMP compliance
- Knowledge and flexibility to work with relevant IT systems
- Fluency in English. Knowledge of German desirable
Assignment start: asap
Assignment duration: until end of 2019 (with chance for prolongation)
Workload: 100% (40h/week)
If you have the required experience and if you would like to apply for this interesting position, please send your complete application documents (CV, testimonials, diplomas) to janine.cabrera(at)kellyservices.ch or apply online.
We are looking forward to getting to know you!