GMP Specialist

m/f/d, Basel-Stadt

We are seeking a highly skilled and detail-oriented GMP Expert to join our client's team. The successful candidate will support and own the Corrective and Preventive Actions (CAPAs) and actions arising from deviations and GMP inspections. The role involves working closely with QC-Capability Leads (QC-CLs) to maintain and improve compliance within our IMP QC operations.

The perfect candidate has a MSc in Pharmaceutics, Analytical Chemistry, or a related field and minimum of 2 years of experience working in a GMP environment. It is really important that the candidate also has strong knowledge of GMP and the ability to work effectively in a fast-paced, team-oriented environment.

Ihre Aufgaben:

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.
Maintain inspection readiness by continuously improving compliance processes and documentation.
Work closely with QC-CLs to ensure alignment on CAPA implementation and compliance improvements.

Ihr Profil:

MSc in Pharmaceutics, Analytical Chemistry, or a related field. A PhD is an advantage.
Minimum of 2 years of experience working in a GMP environment with a strong focus on HPLC and GC analytics.
Demonstrated expertise in analytical method validation, and troubleshooting.
Strong knowledge of GMP regulations and guidelines.
High attention to detail and a commitment to maintaining the highest standards of quality and compliance.

Apply now

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