Documentation & Training Administrator

NUSANTARA PRIME CONSULTING PTE. LTD.; Singapore; Vor Ort; SGD 42.000 - 60.000; Vollzeit

Zusammenfassung

NUSANTARA PRIME CONSULTING PTE. LTD. is seeking a hands-on GMP operations support professional in Singapore.

The role focuses on document execution, training administration, and daily departmental support within established quality systems to ensure GMP compliance and data integrity. Responsibilities include document lifecycle execution, control activities, audit preparation, training coordination, and departmental meeting support, with 12-month duration and potential renewal based on

Qualifikationen

• Diploma or higher in Pharmaceutical Manufacturing, Pharmacy, Biotechnology, Bioengineering, Chemical Engineering, Microbiology, or related fields.
• Basic working knowledge of GMP principles and documentation practices.
• Experience with electronic document and training management systems is an advantage.

Aufgaben

• Support GMP document lifecycle activities (SOPs, OJTs, JCs, SRDs, TRAs, etc.) including initiation, routing for review, implementation, review tracking, and archival.
• Perform department-level document control activities: logbooks, document registration, filing, version tracking, obsolescence handling.
• Support setup and maintenance of GMP documentation under QA guidance.
• Track document status and follow up with owners on actions.
• Assist in preparation of documentation and training records for audits and training activities.
• Maintain audit-ready training records in line with regulatory requirements.
• Coordinate departmental meetings and minutes, action item tracking.
• Support 5S, Kaizen, and continuous improvement initiatives.

Kenntnisse

GMP knowledge

Documentation practices

Attention to detail

Training administration

Ausbildung

Diploma or higher in Pharmaceutical Manufacturing

Tools

MS Office

Electronic document management systems

Jobbeschreibung

Summary:

This role will provide hands-on GMP operational support with a focus on document execution, training administration, and daily departmental support activities. The incumbents will work within established quality systems and procedures, supporting compliance with GMP and data integrity requirements.

Responsibilities:

• Support the execution of GMP document lifecycle activities (SOPs, OJTs, JCs, SRDs, TRAs, etc.) including document initiation support, routing for review/approval, implementation, periodic review tracking, and archival.
• Perform department-level document control activities: logbooks, document registration, filing, version tracking, and obsolescence handling.
• Support the setup and maintenance of GMP documentation under guidance from QA and department leads.
• Track document status and follow up with document owners on pending actions.
• Support document change controls related to updates or revisions.
• Support preparation of documentation and training records for internal and external audits.
• Support and coordinate training activities.
• Maintain accurate and audit-ready training records in line with regulatory requirements.
• Support coordination of departmental meetings (morning, safety, compliance), including scheduling, minutes, and action item tracking.
• Assist in department programs such as 5S, Kaizen, and continuous improvement initiatives.
• Support daily administrative activities including onboarding/offboarding coordination, intern support, and general operations administration.
• Provide operational support for client visits and audits.

Requirements:

• Diploma or higher in Pharmaceutical Manufacturing, Pharmacy, Biotechnology, Bioengineering, Chemical Engineering, Microbiology, or related fields.
• Basic working knowledge of GMP principles and documentation practices.
• Experience with electronic document and training management systems is an advantage.
• Proficient in Microsoft Office applications.
• Detail-oriented, organized, and able to follow procedures accurately.
• Willing to support shift work, weekends, or flexible schedules as required by operations.
• 2-3 years of experience in the pharmaceutical or biopharmaceutical industry.
• Prior experience in GMP documentation, training administration, or operations support is preferred.
• Experience in cleanroom or regulated manufacturing environments is an advantage.

Duration: 12 months, renewable based on performance