Job Description

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\xe2\x80\x94where your purpose accelerates our mission.

Essential Duties & Responsibilities:

Handling of Product Quality Complaints (PQCs) & Medical Device Reports (MDRs) Management in Malaysia:

• Following the applicable procedures on complaint handling process per Corporate, regional, and local procedures
• Collecting relevant product complaint information (Using call scripts when applicable)
• Coordinating sample shipment when applicable
• Identifying potential therapeutic product adverse event information and understanding the requirements for notifying appropriate Pharmacovigilance Units
• Submitting regulatory reports when applicable to Authority
• Ensuring appropriate responses are provided to the customer where required
• Training local functions on product complaint processes and regulatory requirements

Field Corrective Actions (FA\xe2\x80\x99s) Management

• Ensure implementation, execution and follow-up of FAs according to Corporate SOPs
• Be the contact person with Health Authority

JDE Expert User

• Be an expert of distribution related aspects in JDE
• Part master maintenance
• Batch recall reports
• Hold \xe2\x80\x94 local coordinator
• Release products for distribution in Malaysia
• Returned goods management
• Product traceability, tracking and accountability, as required

Quality Management System (QMS)

• Implementation and maintenance & Documentation implement at country level applicable QMS and SEA procedures
• Ensure all relevant SOPs are in place to meet QMS requirements, GDP standards and local regulations
• Ensure documentation life-cycle management in Malaysia

Internal Audits & External Audits Management

• Manage the annual internal audit program
• Perform/ document internal audits of country
• Support and drive the execution of corrective actions
• Perform audits of the third parties involved (e.g. distributors, wholesalers)
• Ensure successful outcome of external inspections by Competent Authorities
• Manage external quality audits for GDPMDS

Supplier Quality Processes Management According to Applicable SOPs

Management of Quality Trainings for Employees & Third Parties and Ensuring Records Availability

Distributor Program Maintenance

• Manage the List of Distributors
• Execute appropriate training and audits

Additional Responsibilities may Include but Not Limited to

• Define and control of quality aspects of third party warehouses
• Participation in quality projects
• Manage the allocated budget

Qualifications:

• Ability of understanding country specific regulations and general quality requirements
• Ability to liaise with different functions involved: e.g. TS, Regulatory, PV
• Ability to liaise with multicultural teams
• Very good spoken and written English
• Good interpersonal and communication skills
• People/Project management skills
• Computer skills (Word, Excel, Power Point, corporate software)
• Subject Matter Expert on Data Privacy

Education & Experience:

• The function requires a degree in Pharma, Chemistry or similar degree in scientific fields
• Ideally, 7 years of experience

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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