I am working exclusively with Global Blue-chip client in their current need to find the next key member for their Quality Compliance team. This is a fantastic opportunity to take a lead in various strategic projects and activities with a company that consistently invests and innovates. You are a highly skilled and successful individual with a background in Quality and regulatory compliance.
In this role you will
- Act as the as the Audit and Inspection Subject Matter on site
- Act as the lead for your department for design and improvement as part of global processes
- Act as a key point of contact for the site for all domestic and international Regulatory inspections, including planning for site inspection readiness
- Take an active and visible role in site inspection CAPA activities
- Lead site based internal audit programs
- Maintain Site Master File
- Consolidate Product Quality reports for Product Quality Lead
- Provides delivery of onsite nonconformance investigations and change controls
- Review site cGMP documents to ensure compliance to regulatory commitments
What you will bring:
- Degree in Chemistry, Chemical Engineering or related field
- 5-8+ years of relevant work experience in GMP the pharma
- Experience working with drug product manufacturing
- Expertise in GxP Regulations and standards
- Track record of successfully coordinating functional project teams and delivery
- ability to lead and influence across varies sites, regions and stake holders
- Experience leading and managing audits and inspections
Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).
