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

• Support QC Method launch activities with QC and other sites/functions

• Coordinate QC method documents changes for regulatory submission

• Author of regulatory submission documents 

• Perform trending for laboratory invalid assays

• Lead and drive invalid results and trend violation investigations independently

• Site SME of global procedure for Invalid results which involves conducting local training and communication with global procedure owner

• Lead method-related investigations for unexpected results independently

• Support Site SME of global procedure for unexpected results in conducting local training and communication with global procedure owner

• Prepare control assignment Protocol/Report for controls as required.

• Support Site SME of global procedure for critical materials in conducting local training and communication with global procedure owner

• Lead and drive control trend rule violation investigations independently

• Author for qualification protocol and qualification report for critical materials

• Support Site SME of global procedure for critical materials in conducting local training and communication with global procedure owner

• Coordinator of new/revised compendial document assessments on local methods and raw material

Education and Experience Requirements

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in Chemistry, Biochemistry, Biotechnology.

• A minimum experience of 3-5 years in Pharmaceutical, Biopharmaceutical or related manufacturing environment.

• Six Sigma Greenbelt training would be helpful.

• Demonstrated experience e.g. in the area of method validation, method transfer, method verification, Unexpected Results investigation.

• Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Interested candidates please send a copy of your resume to leonleong@recruitexpress.com.sg 

Leon Leong De Cong
R1551708
Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599