Batch Record Specialist

Batch Record Specialist

Contract: 12 months | Location: Singapore

The Batch Record Specialist will support manufacturing documentation activities within a regulated pharmaceutical manufacturing environment. The role is suitable for fresh graduates or candidates with limited industry experience who possess strong attention to detail and an interest in GMP manufacturing.

Key Responsibilities

• Review and revise Batch Manufacturing Records and related production documents.
• Update documents based on approved process, equipment and procedural changes.
• Ensure batch records are clear, accurate, consistent and compliant with established documentation standards.
• Perform document formatting, proofreading and data-verification checks.
• Support the routing of documents for review, approval and issuance.
• Maintain document versions and ensure obsolete records are appropriately controlled.
• Work with Manufacturing, Quality and technical teams to resolve documentation queries.
• Support the correction of documentation discrepancies and follow up on outstanding information.
• Assist with SOP, work instruction and manufacturing-form revisions where required.
• Maintain accurate documentation trackers and provide regular progress updates.
• Follow GMP, data-integrity and document-control requirements.
• Support other manufacturing-documentation activities assigned by the team.

Requirements

• Diploma or degree in Biotechnology, Pharmaceutical Science, Chemical Engineering, Biomedical Science, Life Sciences or a related discipline.
• Fresh graduates are welcome to apply.
• An internship or project experience within pharmaceutical, biotechnology, medical-device or regulated manufacturing environments would be advantageous.
• Basic understanding of GMP and good documentation practices is preferred.
• Strong written English and proficiency in Microsoft Word and Excel.
• Meticulous, organised and able to identify inconsistencies in detailed documents.
• Comfortable working with multiple documents and completing work within agreed timelines.
• Able to communicate effectively and collaborate with Manufacturing and Quality stakeholders.