
Search by job, company or skills
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
Job ID: 146326095