Description
A global healthcare company is currently seeking a QP to work in their new site in Dublin.Requirements:
- Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive /EC & /EC and EU GMP Annex 16.
- Assist in the coordination of the QA operational duties relating to product disposition.
- Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.
- Ensure product release procedures comply with current regulatory and company requirements.
- Ensure product periodic quality reviews are performed in timely manner and are reviewed and appropriate actions implemented.
- Approve declaration of GMP for API's.
- Ensure continued effectiveness of site Quality System through regular self-inspections and spot checks.
- Review of results from on-going stability studies and ensure appropriate actions are implemented.
- Review equipment qualification and process validation protocols.
- Perform technical assessments of contract manufacturing facilities and equipment vendors.
Requirements:
- Meets qualification requirements for a QP as listed in EU Directive /EC.
- Previous experience of certifying medicinal product (previously or currently listed as a QP on an EU manufacturing licence).
- 5 year plus quality experience in pharmaceutical industry encompassing manufacturing and packaging operations.
- Working knowledge of EU and US GMPs
- Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
- Good team working and strong communication skills across functions and organization.
- An ability to work flexibly in a changing environment.
- Good attention to detail and priority management essential.
If you are interested in this great opportunity please apply below with an up to date CV.