Pharmaceutical Compliance Expert

vor 10 Stunden

Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit

We are seeking a highly skilled Pharmaceutical Compliance Expert to join our team at ITech Consult AG. The successful candidate will support and own Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections.

The ideal candidate has a Master's degree in Pharmaceutics, Analytical Chemistry, or a related field and minimum of 2 years of experience working in a GMP environment. Strong knowledge of GMP regulations and guidelines is essential, as well as excellent organizational, communication, and problem-solving skills.

CAPAs and Deviation Management:

  • Lead and manage CAPAs and actions from deviations, ensuring timely and effective implementation.
  • Conduct thorough investigations of deviations to determine root causes and develop appropriate CAPAs.
  • Document all CAPA activities in compliance with GMP regulations and company procedures.

GMP Support:

  • Maintain inspection readiness by continuously improving compliance processes and documentation.
  • Collaborate with QC-Capability Leads (QC-CLs): work closely with them to ensure alignment on CAPA implementation and compliance improvements.
  • Provide expert guidance and support to QC-CLs in addressing GMP issues and enhancing quality systems.

Quality System Improvements:

  • Identify areas for improvement within the quality systems and lead initiatives to enhance compliance.
  • Develop and update SOPs (Standard Operating Procedures) and other quality documentation as needed.
  • Conduct training sessions and workshops to reinforce GMP compliance across the organization.

Monitoring and Reporting:

  • Monitor the effectiveness of implemented CAPAs and GMP actions.
  • Compile and present regular reports on CAPA status, trends, and improvement initiatives to senior management.

The perfect candidate will have hands-on experience with additional analytical techniques, previous experience in a leadership or project management role, familiarity with electronic laboratory information management systems (LIMS, LES, SAP), and fluency in English. German language skills are an asset.

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