Document Controller II

Position Overview

Our client, a biopharmaceutical manufacturing company located in Tuas, Singapore, is in search of a seasoned Document Controller II to handle and maintain GMP-compliant documentation. The role focuses on ensuring the precision, compliance, availability, and regulatory adherence of documents to support operational and quality excellence.

Key Duties

• Manage the document management system (DMS) encompassing SOPs, batch records, protocols, reports, and other GMP-driven documents.
• Facilitate workflows related to document initiation, revision, review, approval, distribution, and issuance.
• Ensure version control, archiving, retention, and retrieval align with GMP and Good Documentation Practice (GDocP) standards.
• Maintain documentation that adheres strictly to internal quality standards and regulatory mandates.
• Monitor review and approval schedules while coordinating with stakeholders to meet deadlines.
• Assist in regulatory inspections and audits by guaranteeing that all documents are well-organized, comprehensive, and accessible.
• Work alongside multidisciplinary teams to manage regular document reviews and updates.
• Provide training and support on document control policies and DMS utilization to staff.
• Serve as a primary contact for inquiries concerning document control and compliance.
• Identify and pursue enhancements to document control procedures and system efficiency.
• Help implement improvements and best practices within the document management process.

Candidate Requirements

• Educational background: Diploma or Degree in Life Sciences, Biotechnology, Quality Assurance, Engineering, or similar fields.
• Between 4 and 8 years of pertinent experience in document control, quality assurance, or regulated manufacturing sectors.
• Prior experience with controlled GMP documentation in pharmaceutical, biopharmaceutical, biotechnology, or healthcare arenas.
• Familiarity with document management systems and electronic quality management platforms.
• Strong knowledge of GMP, GDocP, and relevant regulatory compliance guidelines.
• Excellent organizational skills with acute attention to detail.
• Effective communication and ability to manage stakeholder relationships.

Preferred Attributes

• Experience in supporting regulatory audits and inspections.
• Understanding of pharmaceutical or biopharmaceutical production processes.
• Proficiency in electronic document management tools.
• Experience with continuous improvement and process optimization in regulated environments.
• Capability to handle multiple priorities efficiently in a fast-paced setting.

Additional Information

This is a contract role lasting through December 31, 2026, based in Tuas, Singapore. Only candidates shortlisted will be contacted.