RESPONSIBILITIES

• Develop and implement training plans for factory-wide employees on GMP (basic and advanced), external training, and manage training programs of other departments.
• Plan and organize appraisal work (coordinate with other departments) on production processes, equipment cleaning processes, auxiliary systems (HVAC, RO water, distilled water, compressed air).
• Periodically control and monitor the environment, water, and compressed air.
• Control and monitor calibration, inspection, and maintenance of equipment and auxiliary systems.
• Check standard operating procedures (SOPs), original production documents/processes, and job descriptions before approval by the Factory Director.
• Monitor the drug production process throughout from the time of importing raw materials for production, packaging until the finished product is shipped.
• Monitor the control of production conditions (temperature, humidity, pressure, cleanliness…) and check during production.
• Check the test report of raw materials (used for production and import-export), packaging, finished products and sign to approve storage or discard.
• Review and sign off batch records and finished product release orders, standard operating procedures, test reports, protocols, appraisal/evaluation reports, and other professional documents under the Quality System quality, such as Quality Manual, Overall Appraisal Plan…
• Monitor product stability testing.
• Check batch record setup and storage.
• Monitor quarantine and preservation (raw materials for production and import-export, packaging, intermediate products, products awaiting packaging, finished products).
• Monitor the application of the code system on equipment, raw materials used for production and import-export, packaging, and finished products.
• Coordinate with the Purchasing department to evaluate raw material and packaging suppliers to have a basis for selecting NCC.
• Monitor the management of the entire system of documents and GMP records.
• Review and resolve non-conforming products and discrepancies occurring in the factory, warehouse, and QC.
• Manage and control changes affecting product quality or GMP systems.
• Manage and control returned goods/complaints from customers.
• Manage and control product recalls when there is a recall decision from the MOH authorities.
• Manage risk assessment to prevent incidents from occurring and improve the system.
• Organize internal inspection work throughout the factory.
• Annual product review to have a plan to improve products.
• At the beginning of each month, report to the Factory Director on the situation and results of assigned work.
• Perform other tasks requested by the Factory Director.
• Update new circulars and decrees (related) of the Ministry of Health and implement them.

REQUIREMENTS

• Level:
  – Graduated from University with majors related to Pharmacy.
  – English reading comprehension.
• Experience:
  – Have 2 years or more in a similar position, majoring in Pharmacy.
  – Experience in GMP approval of Pharmaceutical factories.
• Character:
  – Agile, enthusiastic, ready to work when required.

BENEFITS

• Full welfare regimes according to Vietnamese state regulations include: Social insurance (100% of salary), health insurance, unemployment insurance, unemployment insurance 24/24.
• Allowances and Company policies: Lunch money, per diem, support payments according to the collective labor agreement, periodic health checks, vacation travel, team building, training to improve qualifications, Accident insurance….
• Bonus: Holidays 2/3, 27/2, 8/3, 4/30 & 5/1, 9/2, Lunar New Year…, bonus 13th, 14th month salary depending on the Company’s performance.
• Evaluate KPI once every quarter, each time bonus from 0.5 – 1 month salary depending on work performance evaluation.
• Leave regime (12 days of leave), holidays according to state regulations.
• Annual salary increase.