Quality Assurance Manager
My client a growing Healthcare Manufacturing company now require an experienced Quality Assurance Manager.
The Quality Assurance Manager has a primary role in assuring that products manufactured at the Midlands site are done so in accordance with cGMP’s and pertinent corporate and regulatory requirements. They will also support the introduction and expansion of new drug product platforms across the site. They will support operational readiness activities in preparation of product launches. The QA Manager reports to the site’s Quality Director.
This is a permanent role based in The Midlands commutable from parts of both Dublin and Galway and it comes with a very good salary with good benefits with great potential opportunities
Responsibilities of Quality Assurance Manager
- Provide quality expertise to the site and ensure operations are in compliance with cGMP
- Manage QA team through QA Specialists to provide quality and compliance support for the site
- Ensure Qualified Person support for site and global batch release
- Provide required metrics and support for internal and supplier management audits
- Effective interaction with other departments on matters related to investigations and finished batch releases. In particular, close contact maintained with the QC, Manufacturing, Engineering and Supply Chain.
- Internal and Supplier Management Audits
- Regulatory and Corporate audit support
- Quality System compliance and improvements
- Excellent working knowledge of risk based validation philosophies, Design of Experiments (DOE) and root cause analysis.
- Operational experience of quality systems in a dynamic manufacturing environment.
- Ability to lead/provide input into technical investigations
- Technical knowledge of sterile manufacturing and pharmaceutical plants
- Understanding of Quality Management Systems and cGMP for US and EU
- Excellent process understanding of the various stages of sterile manufacturing through to inspection and packaging.
- Knowledge of project management fundamentals.
Requirements of Quality Assurance Manager
- Degree in Science or related area (Chemistry, Microbiology or Pharmacy preferred)
- 5 – 7 years’ experience working in the pharmaceutical sector including sterile manufacturing with experience of Ophthalmic Products desirable..
- 3 - 5 years’ experience in management of QA
- Project Management Experience
- Hosting of Regulatory and Corporate Inspections
- Qualified Person status desirable
To apply please click apply below or call 01-2302400