QA Operations Manager

Reporting to the QA Director, the QA Operations Manager will ensure that sterile products (New Product Introduction (NPI) and Commercial) are manufactured, filled and released at AbbVie Biologics Ballytivnan (ABB) meet the regulatory requirements for patient safety and efficacy and comply with Regulatory Authority Requirements that the product is been released too.

Main duties and responsibilities:

• Ensure that all NPI and Commercial Products manufactured at AbbVie Biologics are in accordance with the relevant GMPs. 
• Ownership and Accountability for the Management and oversight for effective product transfer of NPIs and transfer to commercial manufacturing processes within AbbVie Biologics.
• Management of site QPs and Manufacturing Quality Assurance (MQA), including NPI and Commercial batch release, product performance and regulatory support.
• Ensuring that sterile and aseptic products manufactured ...

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