QA Manager

Chi tiết - QA Manager

QA Manager

  • Industry: Pharmaceuticals & Medical Science
  • Form of work: Fulltime
  • Field: QA/QC
  • Posted date 24/04/2024
  • Location: Ho Chi Minh
  • Expired date: 31/05/2024

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CONTACT

Company Contacts:

Person in charge:

RESPONSIBILITIES

  • Develop and implement training plans for factory-wide employees on GMP (basic and intensive), 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, and finished products and sign approval for warehousing or disposal.
  • Review and sign off batch records and finished product release orders, standard operating procedures, test reports, protocols, appraisal/evaluation reports, and other specialized 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.

REQUIREMENTS

  • Qualification: University graduate with majors related to Pharmacy.
  • Basic English communication and reading comprehension level
  • Experience: 4-5 years or more in a similar position, specialized in Pharmacy
  • Have experience in GMP approval of Pharmaceutical factories
  • Agile, enthusiastic, ready to work when required.

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