Quality Operations Compliance Specialist
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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