QC MI&S Specialist ( Pharmaceutical MNC, GMP, Medical)

QC MI&S Specialist (Pharmaceutical MNC, GMP, Medical)

Responsibilities:

1. Support QC Method launch activities with QC and other sites/functions.
2. Coordinate QC method documents changes for regulatory submission.
3. Author regulatory submission documents.
4. Perform trending for laboratory invalid assays.
5. Lead and drive invalid results and trend violation investigations independently.
6. Serve as Site SME of global procedure for invalid results, conducting local training and communication with global procedure owner.
7. Lead method-related investigations for unexpected results independently.
8. Support Site SME of global procedure for unexpected results in conducting local training and communication with global procedure owner.
9. Prepare control assignment Protocol/Report for controls as required.
10. Support Site SME of global procedure for critical materials in conducting local training and communication with global procedure owner.
11. Lead and drive control trend rule violation investigations independently.
12. Author qualification protocol and qualification report for critical materials.
13. Coordinate new/revised compendial document assessments on local methods and raw material.

Education and Experience Requirements:

1. Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.
2. A minimum of 3-5 years experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.
3. Six Sigma Greenbelt training would be helpful.
4. Demonstrated experience in method validation, method transfer, method verification, and unexpected results investigation.
5. Demonstrated ability to collaborate with cross-functional or cross-sites to achieve objectives.