QA Lead

QA Lead

  • Apothecary
  • Contract

Requirement:

  • Apothecary with minimum 2-3 years experience
  • Responsible, hard worker, fast learner, and strong leadership
  • Able to work individually and with team as well
  • Have received training and understand the Good Manufacturing Practices (CPOB)
  • Fluent in English both speaking and writing

Job Description:

  • Providing input to the QA Manager in making the Validation Program and matters related to Validation for the preparation of Budget Quality Assurance
  • Prepare process validation protocols and reports for the production scale and pilot scale for existing products, validate procedures for cleaning equipment and machines
  • Coordinate with related Supervisors in carrying out Process Validation, Validation of equipment and machine cleaning procedures and Validation of Supporting Facilities
  • Coordinate with the IT Department in preparing and implementing computerized system validation.
  • Monitor the implementation of sampling, testing and inspection during the validation process in accordance with SOP.
  • Responsible for conducting CPOB self inspection in the area of PT Medifarma Laboratories
  • Maintain Change Control and Quality Deviation Report (QDR) documentation
  • Coordinating and tracking CAPA related to audits, change control and QDR
PT Medifarma Laboratories

Medifarma Laboratories is a pharmaceutical company based in Indonesia and an affiliate of United Laboratories, Inc., the biggest pharmaceutical company in the Philippines and a sister company of Darya-Varia Laboratoria, Indonesia. With its head office in Depok, on the southern outskirts of Jakarta, Indonesia’s capital, the Medifarma production facility is located in a complex that houses such big-name multinational pharmaceutical companies as Bayer Health Care, Glaxo Smith Kline, Pfizer, etc.