Description
Qualified Person required for aseptic pharmaceutical facility based in Dublin. As the Qualified Person you will work within a team of QPs and manage all product release, compliance and quality management systems.The job is within a well established and well known pharmaceutical company that is looking to expand their QP team due to new product introduction.
Duties:
- To perform duties of the Qualified Person in compliance with all applicable EU GMP regulations and directives.
- Support batch release activities within the regulatory and corporate framework to ensure timely release of products.
- Ensuring compliance of Quality System and maintained through training and internal audits.
- To manage Quality System activities such as non-conformances, out-of-specifications, complaints and ensure compliance at all times with GMP and all relevant EU regulatory and legislative requirements.
- To assist in the development of a right first time, quality culture.
- Drive the continuous improvement of the Quality System.
Requirements:
- 3rd level degree qualification in Pharmacy, Chemistry or Biology
- Approved QP status or eligibility for the QP role
- 5 years experience in a licensed Pharmaceutical facility
- 3 years experience as a Qualified Person or senior role within QA
- Experience of aseptic/sterile pharmaceutical production within a senior role
This is a salaried position, €65,000-€70,000 DOE.
The contract will initially be for a 6 month period.
If you are interested in this role and meet the requirements contact Meadhbh Langton on or apply with your cv.