Specialist, Manufacturing Compliance

vor 1 Woche

Couvet, Schweiz WuXi AppTec Vollzeit

The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she is the manufacturing referee for the batch record creation and revision in PAS-X electronic system.

This is a Role with Long-Term Potential

  • Initiate deviations and participate in or lead floor investigations. Collaborate with QA and Packaging or Bulk Operations to ensure thorough assessments and investigations.
  • Follow up and implement assigned Corrective and Preventive Actions (CAPAs).
  • Author and review manufacturing (bulk/packaging) documents, including specifications, working practices, Forms, and logbooks. Monitor approval flow within electronic documentation system and facilitate input from all stakeholders to ensure timely updates and approvals.
  • Lead risk assessments and risk management cross-functional teams (from draft to approval).
  • Act as a manufacturing referee for the batch record creation and revision in PAS-X electronic system: provide manufacturing input, conduct required testing and manufacturing execution to support batch record testing and qualification. Review and approve the batch record and associated Parameters value list (PVL) in PAS-X system.
  • Conduct complaint investigations linked to Manufacturing.
  • Initiate, own, and follow up on change controls related to manufacturing (bulk/packaging). Coordinate stakeholders involved.
  • Contribute to continuous improvement by proactively identifying issues, collecting input from the operational team, and suggesting solutions.
  • Participate in or lead projects and initiatives as instructed by the Head of manufacturing (bulk/packaging Operations.
  • Act as a quality system and GMP Documentation referee for the manufacturing (bulk/packaging Ops Team and as a key Bulk/Packaging team representative for QA Ops.
  • Support the Head of Packaging Operations in actively monitoring Quality and performance metrics and proposing improvement measures.

Experience / Education

  • BS/MS in Engineering/Technical discipline or equivalent experience
  • 8 years' experience in pharmaceutical validation, packaging, or related field

Knowledge / Skills / Abilities:

  • Solid understanding of current international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines, and GAMP
  • Experienced in Health Authority inspections (preparation, process, presentations, response drafting, etc).
  • Understanding of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Strong ability to collaborate effectively across functional areas and levels to achieve outcomes,
  • Effective verbal and written communication skills,
  • Strong analytical, problem-solving, influential, and deductive skills,
  • Ability to work with tight deadlines and multiple activities simultaneously,
  • Excellent organizational and project management skills,
  • Successful experience in direct people management,
  • Proficiency in French and English

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