We are looking for an experienced Quality Manager to lead and develop the Quality Function for our clients in County Kerry. You will be responsible for the management of the Group’s Quality area and to support the Regulatory affairs team in the preparation of MA applications and dealing with other issues related to the product Regulatory life cycle.
- Managing the Quality Control and Quality assurance functions of the business.
- Further developing the in-house Quality & QA systems associated with existing product manufacture and supply including:
- Raw material and packaging specifications
- Manufacturing processes & Production Batch records & process validation data
- Analytical methods and Method validation Studies
- Stability Studies
- Technical agreements with CMO’s and API and packaging suppliers
- Auditing, training, doc control
- Customer and Quality complaints management
- Managing and Supporting product life cycle regulatory issues including, national phases of licencing, post marketing changes/variations, amendments, renewals and system oversight etc.
- Supporting reg team needs for documentation re Part 2/CMC for further marketing authorization applications. Completing on Part 1 admin sections of MA applications.
- Manage liaison as needed with CMO’s, API suppliers, providing technical and quality inputs on Quality, QA matters, including change controls, process deviations etc
- Liaise with Supply Chain in all Quality related issues and support the risk mitigation strategy and plan.
- Other duties relating to pharmaceutical aspects of the products that may arise.
- Science degree in a related pharmaceutical discipline.
- Experience working in a senior role in a GMP quality system.
- Prior experience managing a quality team in a GMP environment.
- Demonstrated knowledge of GMP, HPRA & FDA Regulation
This is a full time, permanent position. A mixture of remote working and on-site attendance can be offered. Salary is open to negotiation and in the region of €65 – €78,000. For further information please email me directly