Description
A global Biopharmaceutical leader is currently looking for an experienced QA Specialist to join their team on a new build project based in Ireland.The responsibilities of the successful QA Specialist will include:
- 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.
- 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 eg Trackwise or similar.
- Technical writing skills required.
- Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.