A multinational, specialty pharmaceutical and medical device company anchored by a collection of world-class franchises and more than 22,000 employees worldwide are looking for a QA Specialist to join a QA team based out of their Dublin site. The organisation develop, manufacture and market a broad range of branded and generic pharmaceuticals, over the counter (OTC) products and medical devices, which are marketed in more than 100 countries.
The Position - Contract - Hybrid
This QA Specialist position will have responsibilities relating to the management, development and administration of the Global Quality Management System (QMS) and QMS operational procedures. Responsibilities include:
- Preparation, implementation and ongoing maintenance of the QMS systems and operational procedures, policies and other related documentation, in compliance with applicable legislation, regulations and regulatory guidance.
- Management of third parties (External Manufacturing Organizations (EMOs) and affiliates) including regular review and auditing of their Quality Management Systems either by organisation personnel or through the management of audits contracted to qualified third parties, to ensure compliance with applicable legislation and regulations.
- Annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
- Batch record review to verify compliance with GMP and Market Authorisation prior to batch release.
- Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
- All applications must have a Degree in Science or a related discipline.
- Minimum of 5 years' experience working Quality Assurance in the Health Care Industry.
- Excellent working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
What's on offer:
- Exciting long-term daily rate contract role within a leading global healthcare company
- Opportunity to work within a global leader giving you access to build your portfolio within the medical device industry
- Potential for a long term opportunity within the organisation
To discover more about this opportunity, apply now or contact Laura Gallagher at HRM on +353 91 782 113 for a confidential discussion.