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: Senior Manager- Quality
Job description
1. Able to monitor and manage of day to day administration of QC & QA functions in factory.
2. Liaison work with Drugs Control for renewal of License.
3. Responsible for effective Implementation of GMP as per Schedule-M guidelines.
4. To Release / Reject each batch of incoming and outgoing materials.
5. To prepare, control and operate the expenses as per approved norms.
6. To maintain and control the printed labelling text matters.
7. To prepare and maintain Approved SOP in the plant and maintain Master Formula methods updated.
8. Review of Inprocess results and necessary feed back to production incase of deviation.
9. Carrying out Periodic Audit at vendor places and depot.
10. To organise and conduct GMP Audits and Training programmes and maintain records thereof.
11. CGMP & GLP enforcement and training.
12. Responsible for handling of products complaints.
13. Able to Control and monitor the production operations without any deviation from approved norms.
14. Responsible for plant Environmental Health and Safety aspects.
15. Ensuring that processes needed for the Quality Management system are established, implemented, and maintained.
16. Reporting on the performance of the quality management system and any need for improvement, and
17. Ensuring the promotion of awareness of customer requirements throughout the Baxter unit.
Candidate Profile
1. Graduate/ Postgraduate in Science or Pharmacy.
2. Minimum 10 to 15 years of experience of working in a reputed Pharmaceutical company. Minimum 5 years in leadership position and minimum 5 years of experience in sterile products.
3. Experience of working in a managerial role in a MNC is desirable
4. Good understanding of Quality Assurance & Quality Control requirements of sterile products.
5. Good understanding of Microbiology concepts, process validations, facility & equipment qualifications.
6. Conversant with Schedule M, EU, PICs & US FDA cGMP guidelines about sterile products.
7. Should be able to provide leadership to Quality team as well as cross functional team in matters related to GMP.
8. Good written & oral communication skills, pleasant personality.
Additional Information:
Experience: 10-15 Years
Location: Alathur (50 kms. from Chennai)
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
End Date: 14th March, 2014
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