Senior Quality Assurance Executive (Pharma)

An exciting Senior Quality Assurance Executive job has arisen in a leading pharmaceutical firm in Ho Chi Minh City Vietnam.

About the Senior Quality Assurance Executive Role:

You will take the responsibilities to provide quality operations in the Vietnam Local Country and is responsible for ensuring quality compliance of the local GxP activities; you will work in close partnership with local stakeholders to support Vietnam’s strategy while maintaining compliance to health authority regulations and company’s quality requirements. You will work in close partnership with local stakeholders to support Vietnam’s strategy while maintaining compliance to health authority regulations and company’s quality requirements.

Key Responsibilities:

• Implement company quality system, quality plan and ensure on-going compliance to quality standard and procedure. Setting up local QMS as required by local regulations
• Implement supplier quality program in accordance to our supplier quality management expectation
• Accountable and oversee the management of local quality activities to support quality operations
• Quality activities include but not limited to: product release, complaints handling, deviations, change controls self-inspection, training, control of GxP documentation, quality risk management, in-country testing requested by health authority, support new product launches, quality oversight of local GMP/GDP activities etc
• Organises / partakes in internal audits (self-inspection) in cooperation with other functions
• Performs other tasks and duties which may be assigned by the immediate supervisor from time to time
• Provide quality expertise and resolution of all product quality issues originating in conjunction with other functions (ie. Regulatory Affairs, Medical, Business Unit, GMS). Timely escalation of reportable events in accordance with processes
• Participate and lead the implementation of integrated GxP enterprise systems (TrackWise, SAP etc)
• Influence quality strategy cascaded from global quality roadmap, and align to business plan
• Drive and strengthen the quality culture
• Prepare SOP and dossiers for GSP warehouse application (FIE)
• Handle QA activities supporting FIE warehouse operations
• Provide oversight of supply requisitioning, storage, issue, distribution, packing and shipping processes in a warehouse environment
• Coordinate with warehouse team and related departments to create, review and improve the standard operation procedure (SOP) and management procedures at warehouses
• Make internal audit plan; periodically/ irregularly check for compliance with quality, security, safety regulations at warehouses
• Document quality assurance activities, such as inspections, measurements and internal audits

To succeed in this role, you must have good communication skills in English.

Key Requirements:

• University Degree or A Bachelor’s degree in Pharmacy, General Medicine or Biology
• Pharmacist Practice Certificate – Import, export, wholesaler in pharma vaccines and biological products
• A minimum of three to five years of relevant QA
• Strategic thinking, strong communication with various levels of internal & external stakeholders
• Good risk assessment, troubleshooting & problem solving, coaching skills

Our client is a multinational pharmaceutical company. It is the largest pharmaceutical company in Asia and one of the top 20 largest pharmaceutical companies in the world by revenue.

If you are driven and looking for a new challenge, this is the role for you.

Apply today.

Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.