Technical Compliance Specialist

Posted 27 May 2022
Job type Permanent
DisciplineScienceLife Sciences

Job description

For our client, a leading international pharmaceutical group, we are looking for a:

Technical Compliance Specialist

The Technical Compliance Specialist will be part of the global endo QA team, ensuring GMP/GDP compliance of Recordati products across the global supply chain, from API to finished products.

Her/his technical expertise will support Affiliates QA and Regulatory functions to assess changes, deviation, OOS/OOE, stability reports and APQRs coming from Recordati CMOs. She/he will also support the Technology Transfer team in manufacturing and analytical transfers.

Key Responsibilities:

  • Testing methods / specifications life cycle management
  • Technical QA support for Change Control assessment (manufacturing and testing)
  • Technical QA support for OOS, deviations assessment
  • Review and approval of protocol, reports, validation/ qualification
  • Stability testing FUST, review, stab program oversight
  • QA support for transfers and regulatory submission/variation, coordinating requests like reference standards, statements (eg Nitrosamine), GMP documents
  • PQR compilation and annual reports establishment
  • Temperature excursions assessment

Minimum Requirements:

  • Sound technical understanding with experience in chemical/microbiological analytics/QC (incl. method validation/equipment qualification) or equivalent, for liquid and solid products including sterile products
  • Technical education in pharmaceutical manufacturing, sterile dosage form is a plus
  • University degree in Pharmacy, Chemistry or equivalent (desirable) + min 5 years relevant experience
  • Good oral and written English and German skills
  • Ability to work independently in a matrix environment
  • Breakthrough Analysis; being Resilient; Continuous Learning
  • Familiar with Laboratory equipment; Quality Control (QC) Testing and Sampling
  • Quality decision making; Good communication skills
  • Collaboration; result-oriented; problem-solving-oriented, Risk Management

Your Application

Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).