QA & RA Specialist

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

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