Commercial Quality Senior Specialist

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—where your purpose accelerates our mission.

Key Responsibilities :

• Appoint as designated person/QMR for GDPMD (if applicable)
• Compliance with Quality Management System:
• Local Documentation Coordinator (coordinate implementation at local level of corporate documentation, author and publish SOPs, SOP periodic review)
• Support Internal audit program planning and execution
• Deviation Management (NCR/CAPA) initiator, owner, investigator or task assignee as needed
• Change Control initiator, owner or task assignee as needed
• Learning professional (support training planning and carry out reporting)
• Support preparation and execution of Quality/Management Reviews
• Customer Eligibility checks
• Ensure readiness to External audits for assigned quality system

• Interact with authority or certification body for assigned quality systems
• Support Distribution operations:
• Carry out transactions in the Enterprise Resource Planning (ERP) JDE to ensure adequate inventory control, traceability, tracking and release of goods
• Incoming, First of Code, Quarantine, Hold, Returned, Special importation and Unlicensed good controls
• Local Supplier Management:
  • Quality oversight of warehouse, distribution and third-party operations (if applicable)
    • Support establishment of Quality Agreements
    • Supplier deviation management (SCAR)
    • Local Complaint Coordinator (if applicable)
• Maintain Quality Management System to ensure compliance to company requirement and local GDP regulation for both drugs and medical devices.
• Maintain and execute Post-Market Surveillance, including but not limited to product complaint handling, FCA, product recall.
• Manage local SOP and process on internal company system, including SOP review, product release, 3PL management, supplier management, document management, change control, internal/external audit, NCR/CAPA/SCAR.
• Support distribution operations
• Conduct quality training and handle ad-hoc projects
• Communicate with BU and global team on a timely basis
• Report, follow-up and trend product complaints.
• Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
• Reply to customer complaints, queries related to quality, presentation to customer on quality.
• Responsible for release of Finished Goods with temperature controlled and after routine redressing.
• Responsible for redressing instruction.
• Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
• The incumbent will be expected to perform other duties as assigned during employment under Baxter.

Job Requirements :

• At least 5 years of relevant experience in medical devices, pharmaceutical and biologics
• Quality assurance experience within a healthcare commercial/business environment
• Regional experience will be an advantage
• Familiarity with Quality system
• Good understanding of GDPMD
• Ability to multitask and prioritize
• Good interpersonal and communication skills & technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to identify compliance risks and escalate when necessary