Description
We are looking for a
QC Transfer Expert (m/f)
Reference: -en
Start: asap
Duration: 17 MM
Place: in Basel
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
- Provide expertise and support QA/QC and other customers technical, analytical and organisational procedures in a matrix organisation
- Ensure and support deliveries, HSE, GMP and regulatory compliance for area of responsibility
- 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 the organisation
- Maintain and adhere to cGMP, SOPs
- Ensure uniform GMP standards by regular exchange with central QA function
- Generate and/or review GMP documents, e.g. testing monographs, transfer and validation documents, change requests and quality agreements
- Manage investigations regarding product quality (e.g. OOS/OOE, deviations)
- 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 an advantage
- General IT-knowledge
Skills:
- Quality manager