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Quality Control Executive

RM 3,500 - RM 4,700 / month

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Factory in i-Park@Senai Airport City

Key Duties and Responsibilities:

  • Participate in internal GMP/GDPMD audits.
  • Assist in monitoring OOS, OOT, non-conformance, deviations, and change control.
  • Train and supervise lab analysts, technicians, and inspectors, overseeing testing and analytical activities according to established procedures.
  • Perform Qualified Personnel duties, including reviewing, verifying, and signing off on testing/analytical reports and batch manufacturing documents. Release or reject materials for production and finished product sales, as delegated by the Head of Department.
  • Review and verify testing/analytical reports and batch manufacturing documents via the SAP system.
  • Update specifications, analytical protocols, and QA/QC documents.
  • Monitor stability programs and environmental control programs.
  • Assist in process validation and quality refinement.
  • Recommend the purchase of instruments, chemicals, and consumables.
  • Handle the installation, operation, calibration, maintenance, and repair of instruments.
  • Maintain laboratory safety and housekeeping programs.
  • Prepare and review the quality portion of dossiers for regulatory submissions.
  • Perform labeling checks and highlight discrepancies against stipulated label requirements for export and import.
  • Undertake any other projects or assignments as directed by the supervisor.

Job Requirements:

  • Minimum degree in Chemistry or Science.
  • 2-3 years of relevant working experience in the pharmaceutical industry or GMP facility
  • Positive attitude, self-motivated, and disciplined.
  • Ability to work independently and under pressure.
  • Team player with good analytical skills and experience in a QC laboratory.
  • Experience in managing or performing testing for stability samples is an advantage.
  • Experience in handling QMS (OOS, OOT, Laboratory Incidents, Change Control, Deviations, etc.).
  • Experience in managing QC inventory, procurement, and calibration of instruments is an added advantage.

Job Type: Full-time

Pay: RM3,500.00 - RM4,700.00 per month

Benefits:

  • Additional leave
  • Free parking
  • Maternity leave
  • Meal allowance
  • Parental leave

Schedule:

  • Holidays
  • Monday to Friday

Supplemental Pay:

  • Performance bonus

Ability to commute/relocate:

  • Senai (81400): Reliably commute or planning to relocate before starting work (Required)

Education:

  • Bachelor's (Required)

Experience:

  • Manufacturing: 2 years (Required)
  • GMP: 2 years (Required)
  • Pharmaceuticals / Biotechnology / Medical related industry: 2 years (Preferred)
  • QC Laboratory: 2 years (Required)

Language:

  • English (Required)

Work Location: In person

Application Deadline: 05/20/2025
Expected Start Date: 04/28/2025