QA Compliance Expert

Only English-written CV will be taken into consideration.
Please note that only selected candidates will be contacted

For our client in STEIN, we are looking for a QA COMPLIANCE EXPERT, for a 12 MONTHS contract.

Duration: 01.06.2018 - 31.05.2019

Workload: 100%

Location: Stein, Aargau

Job Description:

- Coordinates and compiles APRs/PQRs in accordance with GMP requirements and ensures that follow-up activities are defined, carried out and reported
- Supporting of diverse IT systems, ex DMT, RMT, Agile CCEX, SAP and others in a QA CPL Role
- Maintains relevant SOPs, supports for GMP training
- Supports/Leads Self Inspections (as Lead auditor or Co-Auditor)
- Initiates and leads quality improvement projects
- Supports execution of Health Authority Inspections, Customer Audits and Novartis Internal inspections
- Coordinates local implementation of the Novartis Quality Manuals and GOPs

Candidate Profile:

Education:

- (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- Post graduate diploma in business administration or equivalent (negotiable)

Languages: German & English spoken and written

Experience:

- Professional experience in Quality Control/Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles/Biotechnology
- Profound knowledge of cGMPs
- Proven track record with FDA, EMEA and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools

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

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