Job Purpose: This position will assist QM manger to ensure the establishment and maintenance of the quality management system to meet WHO GMP, ISO as well as other regulatory and company requirements. This role will supervise team members and provide the on-the-job coach and guidance.
Task & Responsible:
1. Assist QM manger to ensure establishment and maintenance of the quality management system to meet WHO GMP, ISO as well as other regulatory and company requirement including:
- Creating, reviewing & revising QM documents. Properly apply production and operation controls to meet GMP, ISO ad related regulatory requirements.
- Establish and lead the annual audit program (internal, external and division) include unplanned audit and inspection.
- Review and finalize QM final statement on deviation, CAPA, audits at B.TraQs system and customer complaint at SAP system based on the investigations and feedbacks of respective stakeholders.
- Coordinate and follow up the CAPA, Customer Complaints, Audits, Change Control, Risk Management with relevant stakeholders to ensure all matters are solved properly and in accordance with requirements, include verify improvement actions and evidence.
- Act as local medical device and nutrient safety officer, include execute properly relevant SOPs for this responsibility: Recall, HHA, Medico Vigilance.
- Coordinate with relevant stakeholders to ensure the technical registration of BBVN at oversee market to be provided properly ad on time in full.
2. Quality records & reports:
- Respond to provide quality reports: weekly, monthly, quarterly, yearly both local and global sides.
- Control and monitor Quality Indicator Performance and QM dashboard
3. Local Safety Officer
- Maintain and monitor the pharmaco, medico vigilance system
- Follow the responsibility about pharmaco vigilance mentioned in effected SOP
- Perform tasks about pharmaco vigilance, medico vigilance as effected SOP
- Team Management
- Manage Compliance & SQM team and Document & Customer Complaint team
- Supervise, coach, be responsible for performance and career development guidance to team members.
- Control qualification matrix of QM team and define training plan for team accordingly.
- Other tasks
- Project management
- Join the defined meeting planned and unplanned, join training batches
Requirement:
1. Education:
Must have:
- Bachelor degree in Technical background
- Quality background knowledge
- Technical background knowledge
- Standard: ISO 9001, ISO 19011, ISO 14644, GMP
- 5whys analysis
Nice to have:
- Pharmaceuticals background is preferred.
- ISO 13485 is preferred.
- ISO 14001, ISO 45001 - 6 Sigma, SPC
- Vietnam regulatory relating to Medical device and Calibration
2. Working Experience
- Must have: 6 years of related working experience or Master s degree with 3 years of related working experience
- Nice to have: Auditor, QC, Production, RA
3. Skills:
- Fluent in English
- Communication, Auditing, Reporting, Presentation, Troubleshooting, Leadership
- Training and coaching skill
