GMP Deviation & CAPA Investigator

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

Job summary

Recruit Express Pte Ltd in Singapore is seeking a GMP-conscious professional to support manufacturing readiness, prepare and revise Master Batch Records (MBRs), and manage change requests.

You will review procedures, perform risk assessments, assist in deviation investigations and CAPA, and coordinate with cross-functional teams to ensure timely closure of quality records. This role requires a Diploma or Degree in Biotechnology or related fields and experience in pharmaceutical manufacturing.

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

Quality systems

Risk assessment

Education

Diploma or Degree in Biotechnology / Biopharmaceuticals / Chemical Engineering / Life Sciences

Tools

Master Batch Records (MBRs)

CAPA processes

Deviation management

Job description

Recruit Express Pte Ltd in Singapore is seeking a GMP-conscious professional to support manufacturing readiness, prepare and revise Master Batch Records (MBRs), and manage change requests.

You will review procedures, perform risk assessments, assist in deviation investigations and CAPA, and coordinate with cross-functional teams to ensure timely closure of quality records. This role requires a Diploma or Degree in Biotechnology or related fields and experience in pharmaceutical manufacturing.