Manufacturing Documentation Specialist (Pharma cGMP) / Joo Koon / Contract

Manufacturing Documentation Specialist (Pharma cGMP) / Joo Koon / Contract

 

Role Summary

The incumbent will assist manager to supervise a team to meet production targets/schedules while always maintaining standards of cGMP, safety, and housekeeping. Along with this the incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and the safety regulations.

 

Manufacturing Documentation and Batch Records

• Support the timely preparation, issuance, review, and completion of batch manufacturing records.

• Act as a subject matter expert for batch manufacturing record review and closure in collaboration with Quality Assurance.

• Review completed batch records for accuracy, completeness, data integrity, and compliance with cGMP requirements.

• Support batch disposition and batch release activities by ensuring manufacturing documentation is complete and compliant.

• Maintain accurate manufacturing, production, and quality-related records in accordance with approved procedures.

• Support updates and revisions to SOPs, Work Instructions, forms, and other controlled manufacturing documents.

• Support implementation of process improvements that enhance compliance, operational efficiency, and documentation quality.

• Support maintenance of manufacturing compliance documentation and training records.

• Attend and support internal, client, and cross-functional meetings as required.

 

Technology Transfer Project Management support

• Support end-to-end technology transfer projects from initiation through manufacturing readiness and successful handover.

• Develop and manage project timelines, milestones, resources, budgets, risks, and dependencies.

• Coordinate cross-functional teams including MSAT, Manufacturing, Quality, Validation, Engineering, Regulatory, and Supply Chain.

• Ensure timely completion of transfer protocols, process documentation, validation activities, analytical method transfer, and GMP requirements.

• Identify and resolve technical, quality, schedule, and resource risks, with clear mitigation and escalation plans.

• Provide regular project status updates to stakeholders and senior management, ensuring alignment on scope, timelines, risks, and key decisions.

• Work closely with Manufacturing, Quality Assurance, Engineering, Supply Chain, Technical Operations, and other relevant functions to support multiple projects.

 

 

Requirements

• Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, or regulated manufacturing industry.

• Demonstrated experience working in a cGMP manufacturing environment.

• Experience in manufacturing documentation, batch record review, investigations, CAPA, change control, and quality systems is a plus

• Good knowledge and practical understanding of cGMP requirements.

• Good understanding of pharmaceutical manufacturing Quality Management Systems.

• Good understanding of GMP documentation practices and data integrity principles.

• Attention to detail and ability to review complex manufacturing documentation accurately.

• Proficiency in Microsoft Office Suite, including Excel and data analysis tools.

• Minimum Diploma in a relevant scientific, engineering, pharmaceutical, biotechnology, manufacturing, or related discipline.

• Degree in a relevant discipline