Job Purpose:
Leading a team of Chemistry Laboratory personnel and operating the laboratory according to the Quality Management System, testing our products to the required quality standards; and fully compliant to regulatory requirements, right first time. To remain impartial to all other pressure from conflict of interest, judgement from financial personnel and shared resources pressure
Job Responsibilities:
- 1.Plan, execute, and document analytical method validation and verification activities in accordance with approved protocols and regulatory requirements.
- 2.Perform analytical testing of raw materials, in-process products, finished products, stability samples, and utilities according to approved specifications and test methods.
- 3.Review analytical methods, support method lifecycle management, and recommend laboratory equipment, chemicals, and reference standards as required.
- 4.Investigate laboratory deviations, OOS/OOT results, and implement appropriate CAPA.
- 5.Prepare, review, and maintain validation protocols, reports, SOPs, specifications, and other controlled laboratory documents.
- 6.Support laboratory equipment qualification, calibration, and maintenance activities.
- 7.Monitor regulatory and pharmacopeial updates and ensure compliance with GMP, GLP, ISO, PIC/S, and other applicable regulatory requirements.
- 8.Provide technical support and training for analytical method validation activities.
- 9.Perform other duties assigned by the immediate supervisor or management.
Job Types: Full-time, Permanent
Pay: RM3,000.00 - RM4,600.00 per month
Benefits:
- Dental insurance
- Health insurance
- Maternity leave
- Parental leave
Ability to commute/relocate:
- Puchong: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person