- Responsible for quality assurance operational activities including managing batch release activities for incoming shipments, local redressing activities, trade returns and write offs, quality related complaints or enquiries and product recall. Work closely with appointed third party service providers and resolve any operational related issues in a timely manner.
- Responsible for maintaining compliance to the Pharmaceutical Management System (PQS) and Regulatory Compliance System, and supporting compliance activities by driving innovation and continuous improvement
Information and Documentation Management:
- Ensure accurate, timely and thorough data entry for Affiliate regulatory activities on relevant Roche systems
- Manage product information updates with respect to Roche and local regulatory requirements and for Roche databases
- Ensure files are managed properly and archive documents are complete and easily retrieved
- Good housekeeping of Quality Assurance areas and inventory, including Filing Rooms
- Responsible and accountable to ensure SOP is updated as per required on a timely manner
- Clearance from Quality Assurance Lead is required for all matters related to quality matters, except routine on-going activities