Operations Supervisor - GMP Documentation & Training Management

WUXI XDC SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

A global pharmaceutical company is seeking an Operation Supervisor in Singapore. This role entails managing GMP documentation, designing training programs, and ensuring compliance with quality systems. The ideal candidate should have 3-5 years of experience in a GMP-regulated setting and a diploma in relevant fields. Strong communication and problem-solving skills are essential for this position, along with proficiency in Microsoft Office. This role offers a dynamic work environment with opportunities for professional development.

Benefits

Production Skills Training

GMP Hands-on Training

Monthly Academic Reports

Qualifications

• 3-5 years of experience in the pharmaceutical industry.
• 2-3 years of relevant experience in GMP documentation and training management.
• Strong English language skills.

Responsibilities

• Manage the entire lifecycle of GMP-controlled documents.
• Design and oversee training programs for compliance with GMP.
• Compile and analyze key quality and operational indicators.

Skills

GMP documentation management

Training program design

Quality systems understanding

Problem-solving skills

Collaboration skills

Education

Diploma or higher in Pharmaceutical Manufacturing or related fields

Tools

Microsoft Office

Gaia system

Job description

Operation Supervisor

Location: 2 Tuas View Drive, Singapore639059

Reports to: Senior Manager, DP Operation

Job Summary

This role is pivotal in maintaining the robustness of our GMP management through expert management of GMP documentation and training programs, while also providing critical support for departmental operations. The ideal candidate will have approximately 3-5 years of relevant experience in a GMP-regulated environment, a solid understanding of quality systems, and a proven ability to manage multiple responsibilities effectively.

GMP Document Set-up, Management & Control

• End-to-End document lifecycle management: Managethe entire lifecycle of GMP-controlled documents (e.g., SOP, OJT, SRD, TRA etc.,) from initiation, through review, approval, effective implementation, periodic review/update, to obsolescence.
• Responsible for designing, implementing, and overseeing training programs to ensure compliance with Good Manufacturing Practices (GMP), regulatory requirements, and organizational competency standard. Moreover, this role involves strategic training planning, execution, and improvement in department operations.
• Collaborate with QA team to set-up GMP documentation system for SG Tuas site.
• In charge of department document management, including organizing, registering, and archiving materials, among other duties
• Document system stewardship: serve as a full license user and owner for the Master Control (MC). Ensure the system is maintained accurately and efficiently.
• Lead department GMP document set-up program and follow closely with team and QA.
• Weekly update to department leadership team the status of GMP document set-up program.
• Lead department JC creation program in a timely manner.
• As POC to coordinate with different departments in terms of GMP documentation management.
• Facilitate the document review and approval workflow. Provide editorial support to document owners to ensure clarity, consistency, and compliance with SOPs and regulatory requirements.
• Review and/or execute change controls related to documentation updates in a timely manner.
• Ensure all document management practices strictly comply with GMP, Data Integrity principles (ALCOA+).
• Prepare and present training records and metrics during internal and external regulatory inspections. Act as SME for the training system during audits.
• Any other duties as and when assigned by the Manager or supervisor.

Training Management

• Manage the MC and Igrow system. Including assigning curricula, tracking completion, sending reminders, and generating training metrics and reports for management review.
• Ensure new hiring onboarding, requalification, and refresher training are conducted as per schedule
• Maintain training records in compliance with regulatory and governmental standards (audit-ready documentation)
• Oversee the delivery of GMP, safety, technical, and compliance training (classroom, on-the-job, e-learning etc.)
• Collaborate with different department POCs or SMEs to develop, update, and maintain role-based training curriculum and JC to ensure they are current and effective.
• Assist in the development and implementation of training effectiveness methods beyond simple completion (e.g., practical assessments, knowledge checks)

Departmental Operations Management

• Compile, analyse, and report on key quality and operational indicators (KPIs) for the department, such as training compliance and CAPA on-time closure.
• Coordinate departmental morning meetings, safety & compliance meeting, including scheduling, agenda preparation, minute-taking, and tracking of actions items to completion.
• Support leadership team to manage DM, Kaizen, WBS, PSP, 5S, Lean Six Sigma program.
• Manage department daily administrative operation, such as interns’ management, orientation of new hirers, on/off board process, team building, working environment management etc.,
• Attendance, OT & shift, leave management by using Gaia system.
• Clients visit and audit support.

Compliance & Continuous Improvement

• Strictly adhere to SOPs and EHS protocols (cleanroom gowning, sanitization procedures)
• Support client/regulatory audits through live process demonstrations and document retrieval.
• Support the revise of relevant operating procedures and related files in accordance with GMP requirements

Qualifications

• Diploma or higher in PharmaceuticalManufacturing, Pharmaceutical Engineering, Pharmacy, Bioengineering,Biotechnology, Chemical Engineering, Microbiology, or related fields.
• Knowledge of GMP is preferred, with expertisein GMP document and training management being an advantage.
• Possess a solid foundation in pharmacy andbiotechnology, with proficiency in Microsoft Office.
• Strong English language skills and the ability to proactively analyze and solve problems that arise in the workplace.
• Good communication and expression skills.
• Effective team collaboration, efficientexecution, and a strong sense of responsibility.
• Flexibility to work on day, afternoon, or night shifts, and on weekends as part of shift rotations, depending on production scheduling needs.

Experience

• 3-5 years of relevant experiences in pharmaceutical industry.
• 2-3 years of relevant experience in GMP documentation and training management role.

Training Opportunities

• Production Skills Training: Helps you quickly meet the technical qualification requirements for your current position.
• GMP Hands-on Training: Media fill qualification, Grade A isolator behaviour
• Equipment Usage Skills Training: Familiarize yourself with the facilities and equipment involved in DP.
• Vocational Training: Become familiar with thecharacteristics and mechanisms of various biopharmaceutical R&D and production, master the skills of efficiently and reasonably managing time, and enhance your core competitiveness.
• Safety Awareness and Professional Training:The company offers a comprehensive system of safety training materials and experienced instructors.
• Monthly Academic Reports: World-renowned scientists and experts are invited to deliver lectures.
• Management Skills Training: Provided by company executives and renowned training institutions to improve employees' practical and theoretical knowledge.