Overview
Manage quality operations in the Asia Region ensuring compliance to the Companys standards and local regulatory requirements for their products.
Main Responsibilities
- Asia QA Team representative/QA Lead Quality Management Representative in responsible countries
- Leading operational quality assurance activities in Asia in the importation secondary assembly/repackaging storage distribution of the Companys products
- Develop executive and maintain QMS
- Oversight of CMOs/Suppliers
- Plan perform and ensure successful closures of internal and external audits
- Provide post market support and resolve quality issues promptly
- Drive the continuous supply of quality compliance products
- Provide quality improvement inputs and support to new product introduction/product launches
Requirements
- At least 57 years quality assurance experience in pharmaceutical and/or medical devices company
- Experience in both manufacturing environment and commercial quality
- Experience in quality operation activities (i.e. importation repackaging release storage and distribution) of pharmaceutical and medical devices products (including sterile liquid/solid products cold chain management)
- Fluent in knowledge and application of GxP standards (e.g. Good Manufacturing Practice Good Distribution Practice) ICH ISO9001 ISO13485 PIC/s
- Proven experience of stakeholder management (e.g. distributors regulatory authorities)
- Audit and inspection experience (e.g. internal regulatory authority CMO supplier)
Remote Work :
No