QA&ra Manager

4 months ago


กรงเทพมหานคร, Thailand BAXTER Full time

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**Summary**:Member of Thailand Leadership team.

Responsible for ensuring compliance to Product release/ Labelling process followed at Baxter controlled warehouse and implementation and control of product complaints management for products sold in the Thailand market.

As a RA head responsible to anticipate and articulate current and future regulator expectations for successful outcomes, including precedence and policy shifts where appropriate. Interpret and communicate regulations and ensure compliance. Manage timely product registration

As a Quality Management Representative for Thailand responsible to effective implementation of the regulations for Good Distribution Practice of Pharmaceutical Products (GDP). Maintain the GDP certificate to continue Baxter permit for Pharma business.

Implements the quality systems procedures and manages quality compliance.
- Responsible for Field Action (FA) such as customer notification letters, product on hold and product recall activities.
- Manage all the customer issues reported and timely reporting of received information through CMS and uses it for improvements in products and services; act with customer in mind.
- Responsible to compliance to MDR (Medical Device Reporting) regulation including the reporting requirements for foreign safety information to Thai MOH every six months (Thai MOH implemented new regulation in 2021 and report to be issued in twice a year).
- Responsible for local NCR and CAPA management and implementation of change control.
- Manage quality related activities for Warehousing, Distribution and Technical service center. Implementation of Quality Management of Third part warehouse and control of labeling activities.
- Perform supplier audits and manage supplier quality for Thailand.
- Participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
- Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations. For example, manage the new product registrations and license renewal as per Medical Device Control Department (MDCD) of Thai FDA. Coordinate with Global Baxter Department supplying medical device to Thailand and arrange to get submission document for classification and align the submission pathways.
- Represent or lead the RA function on assigned cross-functional project teams.
- Monitor applicable regulatory requirements; assure compliance with Baxter and external standards. For example, implement the requirement of medical devices labeling which include Product label and IFU for Thailand specific information e.g., Local license number, Local MAH, etc.
- Establish appropriate communication within RA and other functions primarily at project level.
- Review promotional material or SOP’s for compliance with local and global regulations.
- Establishes and maintains effective relationships with internal customers and gains their trust and respect.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

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