Our global pharmaceutical client is looking for a Quality Manager/QP to join their team based in Offaly. This person will act in the capacity of a Qualified person to support, improve, and maintain the quality management system.
Responsibilities:
- Manage Quality Operations, Batch Disposition team and Regulatory Affairs professionals.
- Ensure compliance with cGMP regulations for batch records and testing operations.
- Maintain QP register and Quality Technical Agreements for batch release.
- Provide real-time support during manufacturing.
- Improve product quality and quality systems, including Annual Product Quality Reviews.
- Review and approve change controls, analytical data, and non-conformance events.
- Support regulatory inspections and manage Site License registration.
- Coordinate internal and external audits and support new product introductions.
- Stay updated on cGMP regulations and contribute to strategic development and continuous improvement initiatives.
- Collaborate with ESQA group and contract filling CMO.
Requirements:
- BSc, MSC in chemistry, engineering or related field and QP qualified with previous QP release experience
- Minimum 5 years experience within a pharmaceutical environment
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
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