Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees.
Post: Team Ldr, Quality-150004QW
Job Description
- Perform and administer quality related activities for Gambro which includes Gambro Sales office and Technical Service Centre.
- Manage and control all SOPs and documents for Gambro.
- Responsible for Quality System of Gambro for SEA.
- Responsible for SEA regulatory bodies GxP compliance.
- Responsible for FCA related actions under Gambro Quality Management System includes customer notification letters, product on hold and product recall activities.
- Manage all product complaint reporting and follow up activities includes investigation result, customer responses and trending.
- Responsible for Internal and External audits for Gambro operations in SEA countries.
- Work closely with QA, RA, BU Heads and Supply Chain partners.
- Provide QMS training for Gambro staff.
- Manage quality related activities for Warehousing, Distribution and Value added services.
- Co-ordinate supplier audits as per supplier quality system for Gambro.
Candidate Profile
1) Must have good verbal and written communication skills
2) Excellent teamwork and coordination skills
3) Good understanding of GxP (eg. Good Documentation Practices, Good Distribution Practices, Good Manufacturing Practices)
4) Good sense of urgency and strong follow up
5) Able to work independently with minimum supervision
Additional Information:
Qualification: Science graduate
Location: Haryana-Gurgaon
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 15th February, 2015
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