QA Manufacturing Compliance Specialist

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

In Abb Vie Ballytivnan
, we are recruiting for a QA Manufacturing Compliance Specialist to join our team. This position will report into the Quality Operations Lead and support the Quality Assurance team. The QA Manufacturing Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and Abb Vie requirements.

The QA Manufacturing Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management.
This role requires shift work.

What you will do:

• Ensure that all products leaving Abb Vie Biologics Ballytivnan meet the standards required for marketed and investigational drug products.
• Ensure that products and aseptic process simulations manufactured at Abb Vie Biologics Ballytivnan meet the requirements of the end users, regulatory authorities and of the company.
• Provide quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
• Provide quality oversight during the aseptic processing of products, including aseptic intervention observation.
• Lead / Assist 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 Line Clearance activities.
• 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).
• Finished product status maintenance, including labelling 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 always maintained.
• Other support as deemed necessary.

What you will need:

• A third level qualification in a science, quality or engineering discipline.
• Minimum 3 years’ experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment (Biologics desirable).
• A strong knowledge of regulatory requirements is required.
• Excellent written and verbal communication skills with a strong attention to detail.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

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