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Coordinate with relevant department to prepare and welcome external audit team, synthesize CAPA report to submit to Audit team as required timeline
Testing management.
Product complaint contact point.
Prepare QMD procedures.
Audit local suppliers / supplier evaluation follow up
Prepare GSP/GDP/ISO/Goods safety and Hygiene Dossiers
Change control.
Risk management for medical devices.
Trains and initiates training program for the proper implementation of the approved quality regulations.
CAPA follow up.
Be responsible for pharmacovigilance (local safety officer – LSO): training, manage and report adverse events.
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.
Yêu Cầu Công Việc
Bachelor’s degree in Pharmacy, with participation in professional pharmaceutical training programs
Solid understanding of pharmaceutical law and relevant regulations
Experienced in GSDP, ISO standards, and validation practices
Strong internal audit skills with close CAPA follow-up
Effective control of product quality and labelling compliance
Problem-solving skills with a win-win approach
Proactive mindset with strong business acumen
Good English communication skills (both written and spoken)
Calm, assertive personality; willing to travel when required
Địa điểm làm việc
Hồ Chí Minh
Công ty TNHH Mega Lifesciences, Lô IV13 KCN Tân Bình, Đường CN2, Tây Thạnh, Tân Phú, Hồ Chí Minh