
Senior GMP Auditor
4 days ago
Our company seeks an experienced professional to plan, conduct, document and report on GMP audits. The successful candidate will ensure compliance with regulations, standards and quality agreements.
- Key Responsibilities:
- Plan and execute comprehensive GMP audits in accordance with our procedures and applicable regulations;
- Document and report audit findings and recommendations;
- Provide technical guidance and training on audit activities;
- Ensure appropriate escalation of critical findings and support immediate follow-up measures;
- Maintain current knowledge of regulations, standards and guidance documents.
The ideal candidate will have the following skills and qualifications:
- At least 10 years of broad experience in Pharmaceutical or Medical Device Industry;
- Strong understanding of QA/QC management and manufacturing principles;
- Excellent communication and interpersonal skills;
- Ability to work independently and as part of a team;
- Sound judgement in interpreting and applying regulations and standards.
This role offers the following benefits:
- Opportunity to work on high-profile projects;
- Professional growth and development opportunities;
- Competitive salary and benefits package;
- Chance to make a meaningful contribution to the industry.
Additional information:
- Experience and/or interaction with local Health Authority and sporadically with other Health Authorities;
- Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
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