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
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