GMP Deviation & CAPA Investigator I

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a detail-oriented professional to support manufacturing readiness in a cGMP environment in Singapore. You will assist in preparing and revising Master Batch Records (MBRs), change requests and other GMP documentation, while ensuring procedures and work instructions align with regulatory standards.

The role also involves reviewing manufacturing procedures, performing risk assessments, coordinating pre-campaign training, and supporting deviation investigations

Qualifications

• Diploma or degree in a relevant field
• Experience in pharmaceutical/biotech/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.

Education

Diploma or Degree in Biotechnology, Biopharmaceuticals, Chemical Engineering, Life Sciences or a related discipline

Job description

Recruit Express Pte Ltd is seeking a detail-oriented professional to support manufacturing readiness in a cGMP environment in Singapore. You will assist in preparing and revising Master Batch Records (MBRs), change requests and other GMP documentation, while ensuring procedures and work instructions align with regulatory standards.

The role also involves reviewing manufacturing procedures, performing risk assessments, coordinating pre-campaign training, and supporting deviation investigations