QA Operations Compliance Specialist

Company Description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Innovate with intention.

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

Welcome to AbbVie!

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 AbbVie Biologics department meet the standards required for marketed and investigational drug products.
• Ensuring that products and aseptic process simulations manufactured at AbbVie 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.

Qualifications

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

Additional Information

AbbVie 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