Operation Supervisor - GMP Document & Training Management

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in Singapore is seeking an Operation Supervisor to oversee GMP documentation and training management. The ideal candidate will have 3–5 years of experience in a GMP-regulated environment and strong communication skills. This role offers a collaborative environment and opportunities for professional growth in biopharmaceutical manufacturing.

Benefits

GMP & Production Skills Training

Hands-on GMP Workshops

Professional Development

Leadership Development

Monthly Academic Seminars

Qualifications

• 3–5 years of experience in a GMP-regulated environment.
• Knowledge of document and training management is preferred.
• Flexibility to support shift-based or weekend operations.

Responsibilities

• Oversee the lifecycle of GMP-controlled documents.
• Administer and maintain training systems.
• Track and report key operational indicators.
• Uphold strict adherence to GMP and compliance protocols.

Skills

Knowledge of GMP principles

Strong written and verbal communication skills in English

Excellent teamwork

Organizational abilities

Problem-solving skills

Education

Diploma or higher in Pharmaceutical Manufacturing

Pharmaceutical Engineering

Medicine

Pharmacy

Biotech

Chemical Engineering

Microbiology

Tools

Microsoft Office

MasterControl

iGrow

Job description

Operation Supervisor (GMP Documentation & Training Management)

Location: 2 Tuas View Drive, Singapore 639059
Reports to: Senior Manager, DP Operation

About the Role

We are seeking a proactive and detail-oriented Operation Supervisor to support our Drug Product (DP) operations. This role is pivotal in ensuring the robustness of our GMP management systems, particularly in documentation control, training program administration, and departmental operations.

The ideal candidate will bring 3–5 years of experience in a GMP-regulated environment, a strong grasp of quality and compliance systems, and the ability to coordinate across multiple functions effectively.

Key Responsibilities

1. GMP Documentation Management

• Oversee the end-to-end lifecycle of GMP-controlled documents (e.g., SOPs, OJTs, SRDs, TRAs) — from creation and review to approval, implementation, and archival.
• Collaborate with the QA team to set up and maintain the GMP documentation system for the Singapore Tuas site.
• Serve as the system owner and full-license user for MasterControl (MC), ensuring accuracy, compliance, and timely updates.
• Facilitate document review and approval workflows, providing editorial and compliance support to document owners.
• Coordinate with cross-functional departments on documentation matters and monitor progress of GMP document setup programs.
• Lead the Job Competency (JC) creation and tracking program.
• Manage change controls (CCs), CAPAs, and document updates in accordance with GMP and Data Integrity (ALCOA+) principles.
• Prepare and present documentation and training records during internal, client, and regulatory audits.

2. Training Management

• Administer and maintain training systems (MasterControl and iGrow) — assign curricula, track completion, and generate compliance metrics.
• Ensure timely onboarding, requalification, and refresher trainings for all employees.
• Maintain audit-ready training records in compliance with GMP and regulatory standards.
• Oversee delivery of GMP, safety, technical, and compliance training (classroom, OJT, and e-learning).
• Work with SMEs and department representatives to develop and update role-based training curricula and Job Competency frameworks.
• Support training effectiveness evaluation through assessments and knowledge checks.

3. Departmental Operations & Administrative Support

• Track and report key operational indicators (e.g., training compliance, CAPA closure rates).
• Coordinate departmental meetings (morning briefings, safety meetings), including agenda preparation, minute-taking, and action tracking.
• Support various continuous improvement programs (Kaizen, 5S, Lean Six Sigma, WBS, PSP).
• Manage day-to-day administrative operations — intern supervision, onboarding/offboarding, attendance, overtime, and leave tracking (via Gaia system).
• Provide support for client visits, site tours, and audit coordination.

4. Compliance & Continuous Improvement

• Uphold strict adherence to GMP, EHS, and cleanroom protocols.
• Support regulatory and client audits, including live demonstrations and document retrieval.
• Contribute to revising and improving SOPs and work processes to align with GMP requirements.

Qualifications

• Diploma or higher in Pharmaceutical Manufacturing, Pharmaceutical Engineering, Medicine (note: replaced to maintain original but placeholder removed), Pharmacy, Bioengineering, Biotechnology, Chemical Engineering, Microbiology, or a related discipline.
• Knowledge of GMP principles and document/training management systems (e.g., MasterControl, iGrow) preferred.
• Proficient in Microsoft Office and experienced in handling documentation systems.
• Strong written and verbal communication skills in English.
• Excellent teamwork, organizational, and problem-solving abilities with a strong sense of accountability.
• Flexibility to support shift-based or weekend operations as required.

Experience

• 3–5 years of experience in the pharmaceutical or biopharmaceutical industry.
• 2–3 years of hands-on experience in GMP documentation and training management preferred.

Training & Development Opportunities

We offer a structured development pathway to enhance your technical and professional growth:

• GMP & Production Skills Training – Build expertise in DP manufacturing operations.
• Hands-on GMP Workshops – Including aseptic techniques and media fill qualifications.
• Equipment Familiarization – Learn key operational systems and assets used in production.
• Professional Development – Gain exposure to Lean, Kaizen, and continuous improvement tools.
• Safety & Compliance Training – Comprehensive EHS training led by experienced instructors.
• Monthly Academic Seminars – Learn from leading scientists and industry experts.
• Leadership Development – Management skills training conducted by senior executives and professional trainers.

Why Join Us?

This role offers the opportunity to play a key part in shaping and maintaining the operational excellence of our GMP manufacturing site. You will work in a collaborative and growth-focused environment, gaining valuable experience across documentation, training, and compliance functions — essential skills for long-term career advancement in biopharmaceutical manufacturing.