Quality Assurance Specialist - Pontypridd, United Kingdom - Just Life Sciences

Just Life Sciences

Verified Company

Pontypridd, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Just Life Sciences are seeeking a Senior Quality Assurance Specialist who will be looking to Provide Technical/Quality Assurance within a Pharmaceutical Manufacturer.

This is a great career opportunity with a view that within 12 months you will be eligible to join the
QP Training programme

Responsibilities

To provide technical Quality support to the Operational departments for new and ongoing projects.
Play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines which assists with regulatory compliance.
To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.
To conduct performance audits and follow up on actions within site business units.
Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)
QA approval of Item Masters.
Batch record compilation and regulatory checks.
Interpret PQR data.
Review and approve Deviations and Change Controls as needed.
To review noncompliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP's), and to initiate and promote quality improvements to preventreoccurrence.
To assist with GMP training within the department and cross site.