Description
We are looking for a
QC Expert (m/f)
Reference: -en
Start: 01/18
Duration: 12 MM++
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Main contact for QA/QC organisation and customers e.g. Process Unit, SCM, RegCMC, PhQA, TRD
- Management of QA/QC processes and procedures, product responsibility, validation and qualification, monitoring
- Maintain and build contacts with external experts, e.g. GQO, TRD, RegCMC, SCM, HSE etc. and ensure fast and direct communication channels
- Provide scientific and technical expertise on QA/QC procedures within ChemOps CH and to other organizations
- Maintain and adhere to cGMP, SOPs, Rolling Review, CAPA
- Prepare, participate in and conduct authority inspections and audits
- Ensure uniform GMP standards through regular exchange with central QA function
- Initiate revision, validation and improvement of GMP documents e.g. testing monographs, SOPs, qualification and validation documents
- Manage investigations regarding product quality (e.g. OOS/OOE, deviations, customer complaints)
- Provide input to health authority requests and maintain state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems
Your qualifications
- University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- German and English skills
- Experience in chemical/pharmaceutical industry is of advantage
- General IT-knowledge
Skills:
- Quality manager