Document Controller

Overview:

Our client in the biopharmaceutical manufacturing industry is seeking an experienced Document Controller II to manage and maintain controlled GMP documentation. The successful candidate will ensure document accuracy, compliance, accessibility, and adherence to regulatory standards while supporting quality and operational excellence across the organisation.

Location: Tuas, Singapore

Duration: Until 31st December 2026

Key Responsibilities:

Document Management

• Administer the document management system (DMS) for SOPs, batch records, protocols, reports, and other GMP-controlled documentation.
• Process document initiation, revision, review, approval, issuance, and distribution workflows.
• Ensure document version control, archiving, retention, and retrieval activities comply with GMP and Good Documentation Practice (GDocP) requirements.

Compliance & Quality Assurance

• Maintain accurate and current documentation in accordance with internal quality standards and regulatory requirements.
• Track document review and approval timelines and follow up with stakeholders to ensure timely completion.
• Support regulatory inspections and audits by ensuring documentation is organised, complete, and readily accessible.

Stakeholder Collaboration & Training

• Collaborate with cross-functional teams to manage periodic document reviews and updates.
• Provide training and guidance to employees on document control procedures and DMS usage.
• Act as a key point of contact for document-related queries and compliance requirements.

Continuous Improvement

• Identify opportunities to enhance document control processes and system effectiveness.
• Support implementation of document management improvements and best practices.

Requirements:

• Diploma or Degree in Life Sciences, Biotechnology, Quality Assurance, Engineering, or a related discipline.
• 4 to 8 years of relevant experience in document control, quality assurance, or regulated manufacturing environments.
• Experience managing controlled GMP documentation within the pharmaceutical, biopharmaceutical, biotechnology, or healthcare industry.
• Familiarity with document management systems (DMS) and electronic quality management systems.
• Strong understanding of GMP, GDocP, and regulatory compliance requirements.
• Excellent organisational, coordination, and attention-to-detail skills.
• Strong communication and stakeholder management abilities.

Preferred Skills:

• Experience supporting regulatory audits and inspections.
• Knowledge of pharmaceutical or biopharmaceutical manufacturing processes.
• Proficiency in electronic document management platforms.
• Continuous improvement and process optimisation experience.
• Ability to manage multiple priorities in a fast-paced regulated environment.

We regret to inform that only shortlisted candidates will be notified.

Job Reference: R25150511 Cammy Li Xin Hui

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544