Description
As a Qualified Person (QP) the successful candidate will work within a team of QPs and will perform all the normal duties of a Qualified Person within a Pharmaceutical unit, to include:- Ensuring that the local Quality System (QS) is adhered to and that Standard Operating Procedures (SOP's) are in place for all GxP related activities and that compliance with GxP regulations is maintained through training and internal audits.
- To perform duties of the Qualified Person in compliance with all applicable EU GMP regulations and directives.
- To manage QS activities and any issues arising, such as non-conformances, out-of-specifications, complaints and recalls ensure compliance at all times with FCL GMP and all relevant EU regulatory and legislative requirements.
- Making representations to management, if necessary in writing, whenever standards appear to be falling short of Good Manufacturing Practices.
- To assist in the development of a right first time, quality culture.
- Drive the continuous improvement of the Quality System and strengthen quality awareness using tools such as internal audit and coaching.
- Support batch release activities within the regulatory and corporate framework to ensure timely release of products including: Support and input into order processing (from a clinical perspective)
- Participate in management of critical monitoring systems
- Using problem solving skills to identify, document and resolve issues.
Qualifications and Education:
- A 3rd level life sciences degree qualification ideally Pharmacy or Chemistry and Biology.
- Approved IMB QP status or eligibility for the QP role
- Minimum 5 years relevant experience in a licensed Pharmaceutical facility with a full ML / ML Specials of which 3 years are performing a Qualified Person or equivalent senior role.
- Experience of aseptic pharmaceutical production gained within a senior role and an in-depth understanding of GMP and QA systems are essential.
If you would like to apply for the position please contat Sarah Irvine on or reply with a copy of your up to date CV.