Posted: 11h ago
The role
QA Operations Compliance Specialist
Location: Ballytivnan, Sligo.
Responsibilities
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 procedures, specifically relating to the operations function to ensure compliance is maintained at all times.
Qualifications
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.
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.
#J-18808-Ljbffr
