QA Operations Compliance Specialist

Innovate with intention.

Science is at the heart of what we do. People are at the heart of why we do it.

Welcome to Abb Vie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

We are recruiting a QA Operations Compliance Specialist to join our site in** Ballytivnan, Sligo. Are you intrigued? Do you want to learn more?**

A snapshot of your key responsibilities as a QA Operations Compliance Specialist would be:

• Ensuring that all products leaving Abb Vie Biologics department meet the standards required for marketed and investigational drug products.
• Ensuring that products and aseptic process simulations manufactured at Abb Vie Biologics meet the requirements of the end users, regulatory authorities and of the company.
• Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.
• Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
• Reviewing/Audit of completed Batch Records.
• Reviewing 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).
• Providing Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
• Administration of Quality Logs, e.g. QA Hold, Sample Request.
• Leading operations floor daily walk around of manufacturing areas.
• Driving continuous improvements and simplify site processes and procedure, specifically relating to the operations function to ensure compliance is maintained at all times.

What you will need:

• 3rd level qualification in a relevant Science degree
• Minimum 3 years’ experience in a similar quality role
• Pharma/ regulated GMP background is essential
• Ability to work under own initiative and to meet tight deadlines

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html