Quality System Specialist (Pharmacist)

Baxter Manufacturing (Thailand) Co., Ltd.

Baxter Manufacturing (Thailand) Co., Ltd. (Pluak Daeng)

Rayong, Thailand

If you have a desire to learn, grow and innovate, you can find purpose and satisfaction at Baxter, and make a contribution to a greater good. Whether you’re interested in medical devices, pharmaceuticals or biotechnology or all three Baxter offers the opportunity to explore the path that’s right for you. Our combined expertise in these three areas is unique and it differentiates us from other companies in the healthcare industry. Our employees around the world are connected by an enduring commitment to save and sustain lives. It’s this higher purpose that binds us as a company and as global citizens. To continue our commitment to meet the healthcare needs of Thailand, we are now seeking talented and driven people with scientist and pharmacist backgrounds for the roles in our new Peritoneal Dialysis Manufacturing Facility.

Detail posisi

Vantive is a new company focused on kidney care, built on Baxter's legacy. The Quality System Specialist (Pharmacist) will play a crucial role in ensuring product quality and compliance with regulatory standards.

Kewajiban

• Work with all departments in implementing and complying with Quality Systems and cGMP requirements.
• Execute the activities of sections or with responsibility for results in terms of product safety, quality, and efficacy.
• Review production batch record and analytical results preparing for release for sale.
• Involve/support team for investigation of any problems related to product safety, quality, and efficacy.
• Support necessary training or coach team for any quality issue.
• Handling of product complaint/FCA’s.
• Coordinate with the customer and team for investigation for product complaint.
• Responsible to follow up the corrective and preventive action of product complaint issue.
• Evaluate new suppliers and maintain existing suppliers.
• Coordinate between supplier and team for supplier corrective actions.
• Conduct supplier audit for new supplier evaluation and maintain existing suppliers.
• Handling of internal and external audits.
• Documentation control.
• Manage and control training in BAXU system.

Kualifikasi

• Bachelor of Pharmaceutical with Pharmacy License.
• At least 1 years of experience in Quality System or any related Pharmacist role in a Pharmaceutical or Medical Device Manufacturer.
• Having knowledge in GMP, PIC/S., or ISO9001.
• Ability to interface with all levels of employees, supervisory & management.
• Strong communication and people skills.
• Knowledge of GMP for medical/ pharmaceutical manufacturing environment.
• Good command of English and Computer literacy.
• Strong analytical and problem-solving skills.