(Sr.) QA Manager (歡迎身心障礙人才申請)
- 台北市中山區
- 5年以上
- 大學
**Please apply through the Workday website: https://novartis.wd3.myworkdayjobs.com/Novartis_Careers/job/Taipei/QA-Manager_REQ-10001512 - "The future of medicine is here." At Novartis, we are reimagining medicine to improve and extend people's lives. We are working hard to produce breakthroughs and address unmet needs for patients with devastating diseases, including genetic disorders and certain deadly cancers. Dreaming and let's change the world together! 【Job Description】 · Ensure compliance of the NCQ organization with cGMP. · Ensure compliance of regulatory requirements and the Novartis Quality Manual and Policies. · Ensure compliance of batch release for commercial products and exceptional management meet KQI and KPI. 【Major Accountabilities】 · Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements. · Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits. · Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country. · Establish a good working relationship with the Supply Chain Management (SCM) and RA departments. · Ensure that coordinated contact is maintained with the Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance. · Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process is in place. · Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards. · Ensure NCQ readiness for all GMP regulatory inspections. · Manage external inspections, complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures. Support / participate in NEM cases as required. · Ensure conduct of adequate training at the NCQ for all GMP and GDP related activities by defining, planning and supporting training activities. · Handling and follow-up customer complaint investigations. · Controlled drug monthly on-line reporting. · Engagement in NCQ project, initiatives and plan. · Other: tasks assignment by manager.