Quality System Specialist (Pharmacist)

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

Position: Quality System Specialist (Pharmacist)
Location: Nikom Amata City, Rayong

Report to: Quality System Supervisor

Main product: Peritoneal Dialysis (Dialysis Fluid)

Job Scope:

Quality System Specialist is responsible for reviewing production batch record and analytical results preparing for release for sale batch release (Batch Release) and conducting audit checks with the company's current quality systems and technologies to ensure adherence to regulatory policies and internal guidelines.

Job Responsibilities:

• 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.

Qualifications:

• Bachelor of Pharmaceutical with pharmacy license.

• At least 2 years of experience in Quality system or manufacturing in a Pharmaceutical or Medical Device Company or regulated industry.

• 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.

Benefit & Welfares:

• Pharmacist License Allowance

• Housing & Transportation Allowance or Shuttle Van provided.

• Canteen, OT, Provident Fund, Health Insurance

• Fixed Bonus, Variable Bonus

• Etc.

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.

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