- Jalan RT 9 Selayang Selangor Malaysia
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
QUALIFICATIONS:
EXPERIENCES:
CHARACTERISTICS:
JOB PURPOSE:
RESPONSIBILITIES:
- Report to the Head of Production on the production performance and address issues related to manufacturing or packaging operations.
- Ensure all activities adhere to GMP, GDPMD, GDP, ISO Standards and other regulatory requirements.
- Lead and assist the Head of Production in planning and executing production schedules to meet targets.
- Manage inventory records and prepare recovery reports for Dangerous Drugs (DD), covering receipt, manufacturing, distribution, and disposal. Coordinate with Bahagian Perkhidmatan Farmasi KKM for routine submissions and annual DD quota applications.
- Handle matters related to DD quotas, controlled drugs procurement, and licensing, including rejected DDs and disposals, in collaboration with Bahagian Perkhidmatan Farmasi KKM.
- Prepare and update SOPs/WIs and other documents related to manufacturing and packaging operations.
- Conduct training sessions, monitor competency in SOPs/WIs, and evaluate production personnel's performance.
- Provide leadership to motivate staff, maximize productivity, and maintain consistent quality in compliance with GMP standards.
- Monitor staff discipline to prevent output issues caused by misconduct or absenteeism.
- Participate in audits or visits by auditors, suppliers, customers, and external service providers in production.
- Review and approve BMR/BPR contents, ensuring alignment with current practices and identifying areas for improvement.
- Conduct final reviews of completed BMR/BPR documents before submission to QA and ensure their accuracy and completion.
- Ensure all manufacturing and packaging activities align with BMR/BPR requirements and are completed promptly.
- Monitor product quality through in-process controls and implement quality assurance programs to meet production standards.
- Notify the Head of Production of any deviations or non-conformances during manufacturing or packaging operations.
- Provide input for investigations into OOS results, product failures, or complaints related to equipment and processes.
- Follow up with supporting departments on issues causing production delays and recommend actions to prevent recurrence under CAPA.
- Assist the Head of Production in closing planned change controls and ensuring effective implementation.
- Participate in internal quality audits, CAPA closures, risk assessments, and propose improvements.
- Ensure adherence to company policies and collaborate with the team to achieve company objectives.
- Undertake any other duties as directed by the Immediate Supervisor and Management as and when required.
Pay: RM2,500.00 - RM3,500.00 per month
Benefits:
Ability to commute/relocate:
Education:
Experience:
Work Location: In person
Peringatan Penting
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