Compliance Specialist

Vor 4 Tagen


Basel, Basel-Stadt, Schweiz Talentify Vollzeit
About the Role

In this challenging role as Compliance Specialist, you will be responsible for ensuring the highest level of compliance with Good Manufacturing Practices (GMP) regulations.

Key Responsibilities:
  • Review and approve documents related to analytical methods, method validations, specifications, risk assessments, deviation reports, investigations, change control records, and stability reports.
  • Develop and maintain quality agreements that define clear quality expectations and standards.
  • Provide technical support to departments on GMP-related matters, offering expert guidance and solutions.
  • Conduct self-inspections to identify areas for improvement and ensure adherence to GMP standards.
  • Oversight of quality control processes for Synthetic Molecules Drug Substance and Drug Product operations to ensure compliance with regulatory requirements.
  • Facilitate training sessions and workshops for staff to improve their understanding of GMP requirements and quality standards.
  • Identify and assess potential risks in production and packaging processes, implementing strategies to mitigate these risks.
  • Drive initiatives for continuous improvement in quality processes, leveraging data and feedback to enhance overall quality performance.


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