QA Compliance Specialist
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
This role will design and implement a plan to ensure complete compliance to cGMP and all regulatory requirements. The plan will ensure audit readiness and successful MOH outcomes for licensure for non-commercial site and inspection readiness for commercial site.
- Implement a comprehensive compliance plan for site licensure. Ensure all quality systems are in place and robust. Prepare the site for PAI and licensure activities. Train and supervise the preparation of SMEs for presentation to MOH.
- Perform internal audit of Quality and operations systems for compliance with MOH guidances and requirements.
- Provide support, expertise, and direction to the DSO sites during regulatory audits and inspection. Develop strategies to ensure successful audit and inspection outcomes for QRM and DI. Provide SME input in terms of CAPA and Investigations.
- Provide assistance with the implementation and coordination of the Internal Audit program. Perform audits as part of the team. Follow up on the implementation of all action items arising from audit observations to ensure timely completion.
- Act as a back up for maintaining the approved supplier list and ensure all material used in GMP activities have complete qualification packages. Perform vendor/supplier or third party audits in collaboration with corporate audit group or as needed.
- 7-10 years in a Compliance/QA role in the Pharmaceutical or medical device industry.
- BA / BS degree
- Strong user of Excel, BMS/SCADA, and IT systems
- Prefer experience in a GMP regulated environment
- Experience with Regulatory and Internal Inspections.
- Solid knowledge of regulatory requirements for biopharmaceutical / pharmaceutical processing, cGMPs.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.