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

Roles & Responsibilities

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

Job Requirements:

• 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 melissa@recruitexpress.com.sg

Melissa Zhang Zhiqi (Mezzo)
CEI No: R2197564
Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599

Tell employers what skills you have

Operational Efficiency
SOP Development
Implementation of Compliance Requirements
Production
Batch Processing
Reviewing
Process Manufacturing
Preparation
Data Integrity
project work instructions
Windows Forms
Quality Assurance Procedures
Field Studies
producing documentation
Project Management Professional
Quality Assurance Processes