The successful candidate will be responsible for:
- Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to manufacturing.
- Acts as quality point person, providing guidance and feedback on quality assurance issues.
- Ensure relevant QA documents and procedures are approved to schedule to support technology transfers and new product introductions.
- Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
- Review and approval of Change control activities to ensure any impact on GMP is appropriately assessed.
- Deliver Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols and reports as required.
- Supports review and approval of quality control documentation for the release of materials on site. Provides oversight of contract laboratories, as required.
- Review and approval of manufacturing batch records to support QP release of drug product in AAMF.
- Supports inspection readiness activities
- Actively contributes to continuous improvement activities.
- Any other duties as required.
- A minimum of 3 years relevant experience within the pharma industry or a related field.
- Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
- Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
- Excellent accuracy and attention to detail
- Good knowledge of relevant computer packages e.g. Trackwise or similar
- Technical writing skills required.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists