For our Swiss customer located in Basel we are currently looking for (m/f) an QA / QC Expert
- Type of placement: 5 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
Responsible for implementing and maintaining the ESO AS&T quality system incl tools & processes. Responsible for providing technical support and problem solving on AS&T and stability aspects of the External Supply organization. Is the Contact for analytical issues at the suppli-ers/CMOs and for stability issues associated with products.
implement and support global AS&T programs in External Supply.
- Defines and implements the business processes and SOPs necessary to maintain a robust Quality System within External Supply affecting the laboratory activities (e.g. management of changes, maintenance of testing monographs)
- Support Implementation of Guidelines at external partners and suppliers
- Lead programs and initiatives to implement changes and to remediate where required
- Interprets stability data, analyzes trends, and provides scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories. Provide corrective actions to address immerging stability issues.
- Support External Suppliers Qualification process
- Support Tech Transfer assessments for analytical method transfers.
- Lead QC aspects of Technical meetings with the External suppliers and establish good working relationships with clear communication and defined actions and goals.
- Support assessments of analytical Change Control records for acceptability. Define studies needed to support the changes.
- Interacts with the External Supplier to guarantee suspect analytical results investigations are managed in agreement with standards and the right CAPA is implemented.
- Ensure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. Support programs and initiatives to implement changes to, and upgrade Testing Monographs where required
- Support site readiness for Health Authority inspections & participate in audits on request.
- Escalate any issues or instances of instability per the escalation policy, and initiate any market action that is required.
- Support analytical trouble shooting as needed.
- University degree in Pharmacy, Biochemistry, Chemistry, or another related science
- Fluent in speaking / writing in English
- 5-8 years experience in the pharmaceutical industry
- Mind. 5 years experiences in QC, method development, validation or stability testing
- Thorough knowledge of cGMP requirements.
- Thorough knowledge of cGMP, ICH guidelines, regulatory requirements & risk management. .
- Good leadership skills and experiences in leading project teams
- Strong track record in project management