Quality Deviation & CAPA Investigator

Recruit Express Pte Ltd; Singapore; On-site; SGD 40,000 - 70,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a quality-focused professional to support GMP manufacturing readiness in a biopharmaceutical environment in Singapore. You will prepare and revise Master Batch Records, update procedures, and assist in deviations and CAPA efforts to maintain cGMP compliance.

The role requires experience with GMP documentation, risk assessments, RCA and change control, and collaboration across Manufacturing and Quality Assurance teams to close quality actions efficiently.

Qualifications

• Min Diploma or Degree in Biotechnology, Biopharmaceuticals, Chemical Engineering, Life Sciences or a related discipline.
• Relevant experience in pharmaceutical, biotechnology or biopharmaceutical manufacturing environments.
• Familiarity with cGMP requirements and pharmaceutical quality systems.
• Experience in GMP documentation, Master Batch Records (MBRs), deviation management and CAPA will be an advantage.
• Knowledge of root cause analysis (RCA), risk assessments and change control processes is preferred.

Responsibilities

• Support manufacturing readiness activities, including preparation and revision of Master Batch Records (MBRs), change requests and other GMP documentation.
• Review and update manufacturing procedures, work instructions and controlled documents to ensure compliance with cGMP requirements.
• Conduct operational risk assessments and coordinate pre-campaign training to ensure manufacturing readiness.
• Support deviation investigations, including root cause analysis (RCA), impact assessments and implementation of Corrective and Preventive Actions (CAPA).
• Coordinate and follow up on deviation records, quality-related tasks, rejected materials and audit findings to ensure timely closure.
• Assist in product impact assessments and investigations to support batch review and lot disposition.
• Collaborate with Manufacturing, Quality Assurance and other cross-functional teams to resolve operational and quality-related issues.
• Ensure all activities and documentation comply with site procedures, regulatory requirements and GMP standards.

Skills

cGMP knowledge

CAPA

Root cause analysis

Risk assessment

Documentation proficiency

Cross-functional collaboration

Education

Diploma in Biotechnology

Degree in Biopharmaceuticals/Life Sciences/Chemical Engineering

Tools

MBR documentation

Deviation management

Regulatory documentation

Job description

Recruit Express Pte Ltd is seeking a quality-focused professional to support GMP manufacturing readiness in a biopharmaceutical environment in Singapore. You will prepare and revise Master Batch Records, update procedures, and assist in deviations and CAPA efforts to maintain cGMP compliance.

The role requires experience with GMP documentation, risk assessments, RCA and change control, and collaboration across Manufacturing and Quality Assurance teams to close quality actions efficiently.