Contract Document Specialist (MNC/ West - Up to $5.5K) #HZO

Location: West

Duration: 1 yr contract

Job Scope

• 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

• Min. Diploma in any relevant field
• Min. 1 -2 years relevant experience in documentation preparation in pharma industry
• Any project management experience is also preferred

Interested candidates may apply by submitting their updated resume to Sign in to view email

Melissa Zhang Zhiqi (Mezzo)

CEI No: R2197564

Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599