Quality Manager
Quality Manager
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Job Description
Job Description
Responsibilities
- Support China quality lead for quality management systems implementation and maintenance to make sure it complaint to company QMS and local regulation requirements
- Be responsible for maintenance/change application process of Drug Distribution License and MD Distribution License
- Provide critical support to ensure related process is in place which meets GSP requirements
- Support inspection / Audit readiness to ensure Health Authority inspections and Divisional inspections
- Conduct the company quality system internal audit investigation on the audit findings and CAPAs development for quality management system continuous improvement.
- Manage GSP/GDP Training system to ensure training and qualification to related employees are sufficient and comprehensive
- Be the key person on 3PL distribution quality lifecycle management contact to ensure the product quality during storage maintenance and transportations etc.
- Lead Drug Annual reporting process and working with RA PV and SCM etc. to make sure timely submission
- Be responsible for product local release activities to ensure timely delivery of products
- Perform other related duties as assigned by management
Required Education Experience and Skills
- At least have bachelor degree of pharmaceutical or related education background
- Must be the China Licensed Pharmacist
- At least 5 years of experience of quality compliance or other relevant experience in pharmaceutical industry
- Prefer to have working experiences in MNC pharmaceutical Drug Distribution company
- Effective English skills for communication in verbal and writing
- Effective communication skills
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Womens Health expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Employment Type
Full Time
