QA & RA Specialist at Baxter International Inc.

Bangkok, , Thailand -

Full Time

Start Date

Immediate

Expiry Date

31 Dec, 25

Salary

0.0

Posted On

02 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management System, ISO 9001, ISO 13485, GDPMD, Good Documentation Practice, Communication Skills, Teamwork, Collaboration, Regulatory Compliance, Medical Device Reporting, Supplier Management, Problem Solving, Proactive Approach, Accountability, Follow Up, Language Skills

Industry

Medical Equipment Manufacturing

Description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Key Responsibilities: As a QA Specialist Responsible for Quality and Compliance management for Thailand, Vietnam and Philippines. Implement the quality systems per Baxter procedures and local regulation with compliance. Manage quality related activities for warehousing and distribution. Cooperate with the Regional Product Post Market Surveillance team to following up the complaint report in timely manners. Escalate information through corporate system and follow up for improvement in product and service; act with customer in mind. Responsible for implement and follow up Field Action (FA) such as customer notification letters, product hold, product correction, advisory notice, or product recall activities. Perform Medical Device Reporting to the local Ministry of Health (MoH) when the quality related issues meet the MoH’s criteria. Escalate Nonconformance Report (NCR) and Corrective Actions/ Preventive Actions (CAPA) through corporate system. Manage related activities and followed up until effectiveness evaluation. Maintain quality related documents and records for TVP cluster. Manage suppliers in related to quality for TVP cluster. Perform supplier setup, re-evaluation, supplier’s change, suppliers’ s corrective actions, or supplier audits. Work closely with stakeholders e.g. RA, BU Heads, Supply Chain, HR, Technical service engineers. Ensure quality systems training to all stakeholders. Authorized Person for product release. As a RA for Advanced Surgery Products, Baxter International Thailand Submit drug importation report and periodic inventory report to Thai FDA for Advanced Surgery products. Approve the monthly inventory report and approve the CoA for custom clearance for Advanced Surgery products. Responsible for new registration and maintain existing registration, variation and renewal for drug and medical device company establishment license. Ensure regulatory compliances of Drug, Medical device and related health product operation following global SOP and local regulations Review promotional material or SOP’s for compliance with local and global regulations. Perform promotional material permission with local regulator as necessary. Keep the information system up to date (RIM, CCDS tracking system, label request. Medical Device controller for Baxter International Thailand to align with Thai FDA regulation. Support Local PV activities for Thailand Support PV with translation of receive adverse events report. Submit ADR to Thai MoH portal. Case follow-up by phone call if needed. Forward the new local regulation to PV team Job Requirements: Valid Pharmacist License in Thailand. 3-5 years work experience in quality role in healthcare industry preferably in a multinational organization Strong verbal and written communication skills Have language skills in Thai and English Understand the basis of Quality Management System e.g., ISO9001 or ISO 13485, GDPMD, or equivalent. Good understanding of Good Documentation Practice. Ability to independently identify quality compliance risks and escalate when necessary Proactive with sense of urgency, accountability, and strong follow up Excellent teamwork and collaboration skills Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.

Responsibilities

The QA & RA Specialist is responsible for quality and compliance management for Thailand, Vietnam, and the Philippines, implementing quality systems and managing quality-related activities. Additionally, the role involves regulatory affairs for Advanced Surgery products, including submissions to the Thai FDA and maintaining compliance with local regulations.