For our client, an international pharmaceutical group that is dedicated to the research, development, manufacturing and marketing of a wide range of innovative pharmaceuticals in several therapeutic areas including rare diseases, we are looking for a
Technical Compliance Specialist
Permanent position (80-100%)
As a Technical Compliance Specialist you will be part of the global QA team (in the field of endocrinology), ensuring GMP/GDP compliance of our client's products across the global supply chain, from API to finished products.
Your technical expertise will support affiliates QA and Regulatory functions to assess changes, deviations, OOS/OOE, stability reports and APQRs coming from CMOs. You will also support the Technology Transfer team in manufacturing and analytical transfers.
- Testing methods/specifications life cycle management
- Technical QA support for change control assessment (manufacturing and testing)
- Technical QA support for OOS/OOE, deviations assessment
- Review and approval of protocols, reports, validation/qualification
- Stability testing FUST, review, stab program oversight
- QA support for technical transfers and regulatory submission/variation, coordinating requests like reference standards, statements, GMP documents
- PQR compilation and annual reports establishment
- Temperature excursions assessment
- Preferably university degree in Pharmacy or Chemistry with at least 5 years of relevant experience
- Technical education in pharmaceutical manufacturing (sterile dosage form is a plus)
- Sound technical understanding with experience in chemical/microbiological analytics/QC (incl. method validation/equipment qualification) for liquid and solid products (preferably incl. sterile products)
- Familiar with laboratory equipment, QC, testing and sampling
- Good oral and written communication skills in English and preferably as well in German
- Ability to work independently in a matrix environment
Workplace: Basel (onsite)
Workload: 80 - 100%
Start date: as soon as possible, according to the agreement
Duration: permanent position
Please apply online. For further information about the position, please contact Ms Nicole Blum (+41 (0)61 270 80 25 or nicole.blum[@]kellyservices.ch).