5/03 【知名生化科技研發業 】Quality Assurance (QA) Sr. Specialist / Manager (819)
- 新北市汐止區
- 3年以上
- 大學
Accountabilities 1. Maintain a comprehensive Quality Management System (QMS) to achieve quality objectives. These include but not limited to: -Oversee QMS activities such as customer complaints handling, deviation management, CAPAs, change controls and quality risk management etc. ensuring they are timely and effectively executed. -Maintain supplier quality management program through timely supplier qualification / requalification audits, follow-up of required actions / CAPAs, and so on. Host regular meetings with the suppliers where applicable. -Manage documentation and training. -Monitor quality-related metrics ensuring their compliance with the set targets -Host quality councils -Coordinate self-inspections and support regulatory authorities' inspection / internal audits 2. Establish and coordinate the local medical quality governance activities that include: -Oversee pharmacovigilance activities ensuring its compliance with relevant GxP regulation. -Oversee and support documentation management and training management in medical quality. -Support qualification of the local diagnostic laboratories and other medical affairs / PV relevant suppliers performing GxP activities. 3. Support cross function activities / projects when required ensuring quality regulations and requirements are followed. 4. Act as the local quality lead during the absence of QA Head 5. Communication with the health authorities in timely and effective manner ensuring smooth release of products and efficient resolution of critical quality issues requiring health authorities' approval.