Batch Record Creation Lead

PSC Biotech; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

PSC Biotech in Singapore is seeking a detail‑oriented professional to lead Change Records for new batch records and SOP updates in a GMP environment.

You will coordinate CAPAs, continuous process improvements, and root‑cause analyses with SMEs, review GMP documentation, and support product changeovers to uphold regulatory compliance and stable production. Strong English communication and teamwork are essential.

Qualifications

• Bachelor’s degree in a relevant life science field (biology, biotechnology, biochemistry).
• Experience in a GMP environment is preferred.
• Strong attention to detail and ability to work independently or in a team.
• Excellent written and verbal English communication.

Responsibilities

• Lead and execute Change Records for creation of new batch records and SOPs.
• Support Change Records assessment and GMP documentation review.
• Coordinate and facilitate small to medium projects to ensure compliant production.
• Lead Continuous Process Improvements, CAPAs and root-cause analysis with SMEs.
• Provide planning, coordination, and performance improvement for manufacturing processes.

Skills

Attention to detail

Organizational skills

Communication skills

English proficiency

Education

Bachelor's degree in life science

Job description

Boon Lay Way, Singapore | Posted on 09/18/2025

• Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production
• Support Change Records Assessment and GMP documentation Review.
• Responsible for providing support to the assigned manufacturing operations by developing, coordinating and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations.
• Lead and execute Continuous Process Improvements, CAPAs and Change Records in assigned area
• Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over.
• Lead project teams to trouble shoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance.
  
• Collaborate with multidisciplinary teams to achieve project objectives.
  
• Assist in experimental design and troubleshooting as needed.
  

Requirements

• Bachelor's degree in a relevant life science field (biology, biotechnology, biochemistry).
• Previous experience in a GMP environment is preferred.
  
• Strong attention to detail, organizational skills, and the ability to work independently or in a team.
• Excellent communication skills, both written and verbal, in English.
  
• Adherence to safety protocols and regulatory compliance.