Quality Operations Compliance Specialist

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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