Senior Quality Management Executive

Trains and initiates training program for the proper implementation of the approved quality regulations.
Risk management for medical devices.
Internal audit lead auditor.
Monthly collecting PV updated information from MOH’s web site, to inform Regional PV group and relevant manufacturers to ensure Package insert, label information of imported products be updated timely as MOH’s requirement before reaching the warehouses.
Product complaint contact point.
Prepare GSP/GDP/ISO/Goods safety and Hygiene Dossiers
Change control.
Be responsible for pharmacovigilance (local safety officer – LSO): training, manage and report adverse events.
Control and prepare report of goods recall.
Coordinate with relevant department to prepare and welcome external audit team, synthesize CAPA report to submit to Audit team as required timeline
CAPA follow up.
Validation management.
Prepare QMD procedures.
Testing management.
Audit local suppliers / supplier evaluation follow up

Proactive mindset with strong business acumen
Solid understanding of pharmaceutical law and relevant regulations
Strong internal audit skills with close CAPA follow- up
Bachelor’s degree in Pharmacy, with participation in professional pharmaceutical training programs
Effective control of product quality and labelling compliance
Experienced in GSDP, ISO standards, and validation practices
Calm, assertive personality; willing to travel when required
Problem- solving skills with a win- win approach
Good English communication skills (both written and spoken)

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Cập nhật gần nhất lúc: 2025-09-16 12:25:03