Regional Quality Assurance Manager
1 month ago
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
- At least 5-7 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)
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