Quality Assurance (Laboratory Equipment Validation)

Only English-written CV will be accepted.

Please note that only selected candidates will be contacted.

For our Client in STEIN, we are looking for QUALITY ASSURANCE (LABORATORY EQUIPMENT VALIDATION), for a 12 MONTHS contract.

Duration: 01/06/2018 - 31/05/2019

Location: Stein, AG (close to Münchwilen)

Workload: 100%

Major Accountabilities:

- The Data Integrity/Life Cycle of Lab Equipment (initial qualification as well as requalification activities).
- The quality aspects of all QC release and monitoring relevant processes
- Providing QA oversight for all GMP related QC activities
- Evaluates and approves the qualification documentation, ie URS, GxP - Risk Assessment, Qualification plan, IQ, OQ, PQ, Qualification report
- Review and approve validated Excel templates according to the local SOPs

Candidate's Background:

Languages: German/English very good knowledge spoken and written

Experience:

- Professional experience in Quality Control/Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology
- Knowledge in CSV requirements and PCS Systems and pharmaceutical software applications, eg LIMS, SAP, Trackwise, etc. is an advantage
- Ability to provide quality risk based advice & judgements.
- Ability to relate and understand paper, electronic and hybrid systems, removal of duplication, effective automation, the validation life cycle continuous improvement mind-set.
- Knowledge of the current CSV and 21CFR Part11 requirements for automated systems and software applications as well as of the general regulatory guidelines (FDA, EU, PIC/S, ICH etc.).
- Profound knowledge of cGMPs

Education: (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent

For further details please contact Aleksandra Sztajerowska.

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