My client, a leading Biopharmaceutical company is seeking a GMP Compliance Senior Expert with a thorough and practical judgement in the interpretation and application of regulations to ensure high product quality and compliance and perform high standard audits of manufacturing & non-manufacturing sites and quality systems.
If you are interested in this new opportunity, please send your CV to Fabrice Akakpo at fabrice.akakpo@secpharma.com and I will contact you for a confidential conversation.
Responsibilities include:
* Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
* Plan and perform audits according to the requirements led down in the respective Company Quality Module. Audits include: pre-qualification audits, routine GMP surveillance audits (both System Based audits and audit focused on special areas/functions e.g. on Stability Program), for cause audits, mock inspections (as part of the site inspection readiness program).
* Conduct pre-approval/pre-submission project reviews and "mock" pre-approval inspections.
* Prepare audit reports according to Company requirements and timelines.
* Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to company Quality Directive on Management Escalation and divisional procedures.
* Act as GMP compliance consultant for Pharma QA projects, GMP trainings, task forces, continuous improvement projects etc.
* Review and revise relevant procedures, as needed
* Maintain state of the art knowledge of regulations
* Support development/training of site inspection management capabilities.
* Support HA commitments and global commitments/initiatives as an outcome of inspection findings.
* Support update of Quality Modules, annual Training Plan and annual Audit Program as a result of audits and inspection trends
Minimum requirements
* Graduate degree in Chemistry, Pharmacy, Microbiology, Engineering or another related science
* Languages: Excellent oral and written English communication skills.
* 10 years broad experience in Pharmaceutical Industry or a related regulated industry.
* Operational experience should include manufacturing, QA/QC management, development or other relevant experience e.g. working at a regulatory health authority.
* Auditor certification by an industry recognized body e.g. ASQ and excellent knowledge of regulatory requirements.
* Willingness to travel approx. 60% of the time
* Expertise in Aseptic manufacturing, expertise in other areas (Clinical/Pharmacovigilance QA) would be additional plus
* Pre-approval inspections incl. Expertise in Compliance and Health Authority Interaction, Microbiology.
* Strong interpersonal skills
* Sound and practical judgement in the interpretation and application of regulations and standards.
* Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese)
If you are interested in this new opportunity, please send your CV to Fabrice Akakpo at fabrice.akakpo@secpharma.com and contact me directly on 0044(0)2072556665 for a confidential conversation.
If you are not looking for an opportunities at present but know a friend or colleague that is, please pass my details forward.
