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Commercial Quality Manager
1 week ago
- Pharmaceuticals
RESPONDSIBILITIES
Mission:
- Provide quality and compliance support for the product portfolio in Vietnam.
- Ensure ongoing compliance of the company BU Vietnam QMS.
- Lead and coordinate the resolution of quality, regulatory, medical and product safety issues affecting products in market.
Primary Responsibilities:
- LOCAL QUALITY MANAGEMENT SYSTEM (QMS) _
- Responsible to support the Country Manager and leadership team to enable them to develop and implement the local Quality Management System (QMS) to ensure fully compliant products.
- Work with local functions to develop and maintain all relevant local procedures in line with the requirements of the Global company Quality Manual & associated policies, relevant codes of practice and GMP/GDP and local requirements.
- Ensure that BU QMS is maintained in a state of inspection readiness.
- Ensure processes are in place to assess the adequacy and effectiveness of the local BU QMS.
- Ensure that improvements to products and procedures can be identified and fixed.
- The individual should understand:_
- The current regulations related to Medicines/Medical Devices/Health Food/Cosmetics and Hygiene products in relation to storage and distribution
- Good Storage and Distribution Practice for company products.
- SPECIFIC INVOLVEMENT IN QMS PROCESSES_
- Change Management: Facilitate the development and maintenance of robust and effective locally based change control system to ensure compliant Market Authorizations.
- Training: Ensure all BU Functional team in commercial organization are aware and trained on the relevant local and global quality procedures.
- Product Recall as per the Critical Quality Events and Product Recall SOP establish and communicate responsibilities. Participate in mock recall exercises to confirm adequacy of the local recall procedure.
- Complaint management: Manage quality complaints from commercial functions and customers by carry out investigation and implementing corrective / preventive actions (CAPA) to prevent recurrence. Supporting Consumer Relation (CRM) team (if required) on consumer complaints.
- Internal / Cross auditing: Responsible for conducting audit programs covering BU QMS, Distribution Centers (DC), Embellishers, and other service providers under scope of responsibility of Commercial Quality.
- Maintain a Fit-ForPurpose
QMS:
Report level of compliance of local BU QMS through periodic Management Review Meetings to local management team.
- DC's and EMBELLISHERS _
- Responsible for initial compliance assessment and approval of Distributors & Embellishers handling RB Products.
- Support the preparation of Technical Agreements (TAs) for Distributors & Embellishers.
- INTERFACE WITH REGIONAL/SUPPLY QUALITY_
- Work with regional and Supply Quality teams to ensure implementation of appropriate controls to ensure consistent quality of products
- Work with the regional and Supply Quality teams to analyses country product data, CAPA and postmarket surveillance information to facilitate Annual Product Quality Reviews.
- SUPPORT INSPECTIONS BY REGULATORY AUTHORITIES _
- Support local business units in the preparation for and responses to inspections by Regulatory Authorities. Ensure that Corrective and Preventive Action's (CAPA) if any, are resolved in a timely manner.
REQUIREMENTS
- Degree of pharmaceutical sciences or degree of sciences
- At least 3 years of experience working in a quality AND/OR regulatory compliance function in a Nutrition, Healthcare, Hygiene, Pharmaceutical, FMCG, or Medical Device related industry.
- Experience in developing and maintaining QMS in a Nutrition, Healthcare, Hygiene, Pharmaceutical, Food, or Medical Device related industry.
- Good understanding of regulatory requirements relevant to a regulated products in Vietnam.
- Clear understanding to ensure local business operations do not compromise the quality of products and can demonstrate compliance with GDP.
For more information, please contact:
- Ms.
Nguyen Thi Hong Tham Ext:
510
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