Description
IMP Qualified Person QP - Dublin - up to € per dayOptimus Life Sciences is working with a multinational bio-pharmaceutical client to find a Qualified Person to join their manufacturing site. Reporting directly to the Head of Quality, you will primarily focus on the batch-release of steriles.
Tasks:
* Provide QP batch-release of product(s) to market.
* Provide easy to follow release procedures which provide a consistent, secure, structured approach that has been repeatedly reviewed during MHRA inspections.
* Provide support to QA department ensuring quality standards and systems follow regulatory and global requirements.
* Global auditing of third party manufacturing, testing, packaging and labelling facilities as required in support of QP declarations for export into the EU.
Requirements:
* A life science degree
* Certified as a Qualified Person under MHRA regulations.
* Wide ranging technical knowledge and experience within the pharmaceutical industry.
* Industry experience in a site producing sterile/solid-dose/IMP pharmaceutical products under EU and US standards including quality management experience.
* Experience cooperating with other QPs
* A good track record with the FDA, MHRA, EMEA and other regulatory agencies.
If you are interested, please get in touch!!