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Quality Assurance Manager for Selatox Bio Pharma

Manager
2024-12-03


※ Submit your Application (Submit Your CV) to: https://linktr.ee/daewoong_pharmaceutical

 

Quality Assurance Manager
Location: Cikarang

 

Responsibilities

  • Developing and implementing quality assurance policies and procedures.
  • Ensure compliance with GMP and ensuring the quality system is implemented in accordance with the latest regulations.
  • Ensure the fulfillment of GMP technical requirements or regulations of the BPOM related to the quality of the finished product.
  • Evaluate and approve product stability data and other registration document data as well as managing other Pharmaceutical Industry Licenses in accordance with the provisions of the Ministry of Health and BPOM of the Republic of Indonesia.
  • Assess and decide on deviation handling and change control.
  • Handle drug complaints, product rejections, and drug recalls.
  • Carry out duties as a responsible person for Pharmacovigilance in the company.
  • Release or reject finished products for sale by considering all related factors.
  • Coordinate and ensure the implementation of calibration, qualification, and validation programs conducted in the company.
  • Conduct annual product quality assessments to evaluate product quality.
  • Initiate and participate in internal and external audit implementations (audits to suppliers, drug manufacturers, and laboratories on a contract basis, Toll-Out Partners).
  • Provide approval and conduct monitoring of material suppliers, drug manufacturers, and analysis based on contracts.
  • Coordinate and ensure the implementation of personnel training programs within the company.

Requirements

  • Bachelor’s degree (or higher) from a recognized Faculty of Pharmacy
  • Minimum of 3 years of experience as a Quality Manager in the Pharmaceutical Industry
  • Preferably a Senior Manager specializing in Quality Control/Assurance or equivalent
  • Proficiency in English (oral & written) and strong computer skills (Microsoft Office)
  • Korean language proficiency is a plus
  • Ability to embrace challenges, critical thinking to resolve arising issues with a business focus
  • Good interpersonal and communication skills
  • Active involvement in professional organizations would be an added advantage

 

※ Submit your Application (Submit Your CV) to: https://linktr.ee/daewoong_pharmaceutical