This role ensures all products leaving the site—both marketed and investigational—meet company, regulatory, and end-user quality standards. It provides quality and compliance oversight to Operations, supporting the manufacture of products in accordance with site policies and procedures.
Key Responsibilities:
* Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
* Review/Audit of completed Batch Records.
* Review of Manufacturing Logs as required.
* Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
* Completion of Incoming Raw Material checks, including product status maintenance (as required).
* Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
* Administration of Quality Logs, e.g. QA Hold, Sample Request.
* Lead operations floor daily walk around of manufacturing areas.
* Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
* Other support as deemed necessary
Essential Requirements
* Third level degree in a science, quality or engineering discipline.
* Ideally previous experience in a quality role
* A minimum of three years’ experience in a quality/operations role in a highly regulated GMP environment. Experience in biologics manufacturing is highly desirable.
* Experience in aseptic processing gained within either a quality or operations role is highly desirable.
* A strong knowledge of regulatory requirements is required.
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