Degree in Chemistry, Chemical Engineering or Biology OR Graduate in Science discipline.
1-3 years working experience in pharmaceutical manufacturing industry.
To act as Quality Liaison Person at operational area (ensure GMP compliance, In-Process Quality Checks, involvement in Root Cause Analysis and Deviation Management).
Job Summary:
Responsible for managing the day-to-day quality operations for the Quality Management system. To ensure Quality Management System established and complies with PIC/S, GDP and GDPMD guidelines and other relevant guideline.
Responsibilities:
Manage, monitor and govern the system of Deviation, Corrective Action and Preventive Action (CAPA), Change Control, Investigation Report (IR), Rework/Reprocess/Redress and other system related to Quality Assurance.
Maintain QMS log and capture identification and traceability for Deviation, CAPA, Change Control, IR, OOS, rework/reprocess/redress and other system related to Quality Assurance.
Manage and govern the Deviation, Investigation, CAPA, Change Control and Rework/Reprocess/Redress from issuance until the closure.
Monitor CAPA and continual improvement plan. Ensure relevant actions have been taken and effective.
Assist in coordinating new or changes of product artwork control for all the preprinted packaging material.
Assist in coordinating supplier qualification and supplier evaluation for alternate / new suppliers of materials and service provider.
Manage and coordinate the product complaint received from Regulatory Bodies and customers by acknowledging the investigation and ensure it close within the timeline.
Assist in investigation for any quality issues in the site.
Assist in product recall by ensure it close within the timeline.
Assist in any external audit and provide post-inspection follow up information as requested.
Assist in any external audit closure and ensure relevant actions have been taken and effective.
Assist in conducting risk assessment and risk management in the site.
To support and perform other QA Executive duties when he/she is absent or out of office.
To adhere to company policies and work as a team in achieving company objectives.
To undertake any other duties as directed by the Immediate Supervisor and Management as and when required.
Job Types: Full-time, Permanent
Pay: RM2,400.00 - RM3,500.00 per month
Benefits:
Additional leave
Dental insurance
Flexible schedule
Free parking
Health insurance
Maternity leave
Meal allowance
Opportunities for promotion
Professional development
Vision insurance
Work from home
Ability to commute/relocate:
Rawang (48020): Reliably commute or planning to relocate before starting work (Required)
Education:
Bachelor's (Required)
Experience:
Quality Assurance: 1 year (Required)
Work Location: In person
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