Qc Executive
2 days ago
**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 is a must.
- 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**: Permanent
Pay: RM3,500.00 - RM4,700.00 per month
Schedule:
- Monday to Friday
Supplemental Pay:
- Yearly bonus
Ability to commute/relocate:
- Senai: Reliably commute or planning to relocate before starting work (preferred)
Application Question(s):
- What is your expected salary range?
- How long is your notice period?
- Where are you located?
**Education**:
- Bachelor's (preferred)
**Experience**:
- pharmaceutical industry: 2 years (required)
- managing or perform testing for stability sample: 1 year (required)
- handling of QMS: 1 year (required)
- handling of QC inventory: 1 year (required)
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