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

Recruit Express Pte Ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company in Singapore is seeking a QC MI&S Specialist to support QC Method launch activities and regulatory submissions. The ideal candidate will have a degree in Chemistry, Biochemistry, or Biotechnology, along with 3-5 years of experience in a pharmaceutical environment. Responsibilities include leading investigations, coordinating document changes, and collaborating cross-functionally. This role is critical to ensuring compliance and quality standards in the laboratory.

Qualifications

• Degree in Chemistry, Biochemistry, Biotechnology or Diploma in related field.
• 3-5 years of experience in Pharmaceutical or Biopharmaceutical manufacturing.
• Demonstrated experience in method validation and unexpected results investigation.

Responsibilities

• Support QC Method launch activities.
• Coordinate QC method documents changes for regulatory submission.
• Lead investigations for invalid results and trend violations.

Skills

Method validation

Collaboration

Six Sigma Greenbelt

Education

Degree in Chemistry/Biochemistry/Biotechnology

Job description

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

Singapore | Posted: Dec 15, 2025

Responsibilities

• 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.