Purpose

Support manufacturing operations in the resolution of events and documentation discrepancies.  Provide guidance for product/process impact analysis, investigations and risk based evaluations in support to plant events. 
Responsible for implementing and maintaining the effectiveness of the Quality System.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility.
• Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
• Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; change management and risk management documents.  Ensures all documents are in compliance with Abbvie global procedures and regulatory requirements.
• Approves calibration requests, calibration out of tolerance and preventive maintenance records.  Ensures that these documents have appropriate justifications according to product /process limits established.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
• Provide support to the Compliance team during internal and external audits as required.