QA for QC Senior Specialist

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 QA FOR QC SENIOR SPECIALIST, for a 12 MONTHS contract.

Duration: 01/09/2018 to 31/08/2019

Location: Stein, AG

Workload: 100%

Major Accountabilities:

- Analytical Change Control Management (QA Gate Approval, Change Phase Management)
- Approval and Implementation of analytical TM (pharmaceutical dosage forms, excipients, packaging materials)
- Approval of method validation (for cleaning validation)
- Review/Approval of analytical change/transfer documents
- Updating of SOPs/FRMs
- Management of customer and HA requests
- Audit and inspection support
- Ensure timely delivery of complete and consistent source data to DRA REG CMC
- Coordinate and provide timely review (on-site) of CMC documentation

Candidate Background:

Languages:

Experience:

- Advanced quality and regulatory understanding
- Experience in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology is an advantage
- Good Analytical chemical and/or biological expertise
- Profound knowledge in cGMPs
- Pharmaceutical software applications, eg TEDI, CCex

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

For further details please contact Aleksandra Sztajerowska: 
(see below)