募集要項
- 仕事内容
-
1) Provide strong support team management for GQP Head on day-to-day basis
2) Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply
Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
3) Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local
regulation and the Sun Pharma Quality Management Systems and provide reports as required
4) Implement, report and monitor CMO Quality Metrics and ensure identification and
implementation of improvements needed through routine review
5) Manage (initiate and investigate) all significant quality issues associated with Drug Products
or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls,
counterfeits and product tampering, stability failures, etc.) appropriately and in a timely
fashion
6) Provide support to develop/implement/maintain/improve QMS in line with local regulation
and Sun Pharma QMS
7) Perform other duties as assigned
- 応募資格
-
- 必須
-
+5 years of experience in QA/QC of Pharmaceuticals and/or Medical Devices;
+5 years of related experience in a GMP/GQP environment;
JLPT N1, business level English.
- 雇用形態
- Full-time
- 勤務地
- Tokyo
- 年収・給与
- Up to 15.00 million yen
