Description
We are looking for a
QA/QC Expert (m/f)
Reference: -en
Start: 01/18
Duration: 12 MM
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Implement and support the ESO AS&T quality system incl. tools and processes
- Provide technical support and problem solving on AS&T and stability aspects of the external supply organization
- Define and implement the business processes and SOPs necessary to maintain a robust quality system within external supply
- Lead programs and initiatives to implement changes and to remediate where required
- Interpret stability data, analyze trends and provide scientifically sound conclusions to support assignment and monitoring of product shelf life, storage conditions, packaging and transport categories, support analytical trouble shooting
- 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
- Support site readiness for health authority inspections & participate in audits on request
- Escalate any issues or instances of instability and initiate any market action that is required
Your qualifications
- University degree in Pharmacy, Biochemistry, Chemistry, or another related science
- Fluent in speaking/writing in English
- Profound experience in the pharmaceutical industry
- Proven experience 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
Skills:
- Quality manager