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Specialist, Manufacturing Compliance
vor 1 Woche
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.
Responsibilities:
- Support deviations and participate in floor investigations.
- Collaborate with QA and Packaging or Bulk Operations for thorough assessments and investigations.
- Ensure implementation of assigned CAPAs.
- Author and review manufacturing (bulk/packaging) documents.
- Lead risk assessments and cross-functional teams for risk management.
- Review and approve batch records and associated parameters in the electronic system.
- Conduct complaint investigations linked to Manufacturing.
- Initiate, own, and follow up on change controls related to manufacturing.
- Contribute to continuous improvement and propose solutions.
- Participate in projects and initiatives as directed.
Requirements:
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 8 years' experience in pharmaceutical validation, packaging, or related field.
- Sound knowledge of international regulatory regulations, GxP requirements, and best practices.
- Experienced in Health Authority inspections.
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
- Strong communication, analytical, problem-solving, and project management skills.
- Experience in direct people management.
- Fluent in French and English.
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Val-de-Travers, Schweiz WuXi AppTec VollzeitOverview 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...
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Val-de-Travers, Schweiz WuXi AppTec VollzeitThe 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...
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Val-de-Travers, Schweiz WuXi AppTec VollzeitThe 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...
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