Pharma Internal Audit Support Needed

I need hands-on support to run an internal audit for a pharmaceutical Quality Management System already aligned with ISO 9001 and cGMP requirements. The scope covers planning the audit, interviewing process owners, sampling records on the shop floor, and drafting the final report with clear findings and CAPA recommendations.

Please be ready to demonstrate solid experience performing audits in the pharmaceutical sector—proof of similar assignments will weigh heavily in my selection. Familiarity with ISO 9001, 13485, cGMP, deviation management, change control and document control is critical, as you will be working directly with our existing SOPs and quality documents.

Deliverables:
• Audit plan and checklist tailored to our processes
• On-site or remote execution of the audit, including evidence collection
• Concise audit report summarising non-conformities, observations and opportunities for improvement
• Drafted or reviewed CAPA actions that are practical and compliant

All materials must remain confidential and be delivered on the agreed timeline. If your background matches the above and you can jump in quickly, let’s discuss the next steps.