LSC have a great contract opportunity for a Quality Auditor to join a top 10 Pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Ensure that the batch has been manufactured and tested in accordance with current GMP Guidelines Directive 2003/94/EC, EC Guide to GMP for medicinal products and/or the FDA Code of Federal Regulations.
- Ensure that the batch is released according to the relevant Annex to the Rules and Guidance for Pharmaceutical Manufacturers and Distributors. In particular Annex 13 - Investigational Medicinal Products and Annex 16 - Certification by a Qualified Person and Batch Release.
- Work with the Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including.
- Application of Quality Risk Management to all process and systems.
- Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply.
- Documentation preparation, review & approval to support operations.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Qualified Person status achieved. Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA) is desirable.
- Proven experience within the Pharmaceutical industry in a QA/QC/Compliance role.
- Excellent knowledge of regulations and sources of regulatory information
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Contact Grainne Hodnett in LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert!