Assistant Manager, Quality Control

Full Time, onsite
GoodScience Sdn Bhd
Selayang, Malaysia

RM 4,500 - RM 6,000 / Per Mon

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JOB PURPOSE

To maintain continuous Quality Control operation and other activities related with QC lab operation in QC division. To be responsible for timely inspection, sampling, testing and reporting of sample according to company policies & fully compliance with PIC/s Good Manufacturing Practice, coaching and leading the team in achieving organization objectives and targets.

KEY ACCOUNTABILITIES

Assist in managing, directing, planning and responsible to all QC lab analyst, and all other QC personnel on their directive on sampling, testing and reporting activities to ensure continuous control and right inspection, testing and to check and review results of all starting materials, packaging materials, intermediate, bulk, finished products not limited to retention samples, stability studies, environmental monitoring and water system monitoring.
Assist in executing, implementing and maintain all other on-going laboratory activities & requirements by ensuring all in accordance with cGMP compliance.
Assisting in approving or rejecting raw materials, packaging materials, intermediate and bulk according to current specification. To discuss with QA on non-conforming prior to final status.
Assisting to review finished products according to current specification prior to batch release by QA.
Assisting to counter check, monitor and maintain all the related QC records and approved documents within the documentation management system.
To conduct on-job-training for laboratory staff on relevant topics and update training record accordingly. To plan competency program for lab analyst under probation and need for supervision personnel.
To lead QC team in identification and recommendation for process improvements as part of a team within or inter-department in order to ensure continuous improvement.
To lead QC team in QC document preparation for internal/external or customer/regulatory inspections related with national regulation.
To conduct internal investigations and troubleshooting related to QC quality management system eg Out of Specifications, incidents & deviation investigations, non-conformity, CAPA etc.
To support and ensure proper QC documents to HRS to comply with regulatory requirements for product registration.
To monitor laboratory operations such as equipment calibration, verification and preventive maintenance.
To ensure method validation performed are complying to protocols and predetermined specification.
Responsible for testing of other samples collected from process validation, cleaning validation, method validation and change parts as per protocols.
To ensure qualification of lab equipment and change control management as per site Quality Management System.
To liaise directly to external service providers/customer on the operation issues.
To monitor and responsible in validity and kept up to date of working standard, test reagent, volumetric solution, inventory on supplies for QC orders involving devices & chemical reagents and all related master list as and when needed.
To participate in relevant project such as material assessment/ sample evaluation and department meetings via input, hands on, feedback and execution of assigned tasks.
To monitor, make an improvement, if necessary, and maintain the work environment cleanliness & tidiness and safe complying with safety and pharmaceutical regulation.
To involve in all audit applied by the company and ensure corrective actions are taken in timely manner & all QC division perform accordingly.
To adhere to company policies and work as a team in achieving company objectives.
To be responsible for staff development, training, discipline, working attitude and performance according to company procedures, policy, and employment law.
To ensure adequate and effective training for staff towards achieving the desired competency level.
Ensuring effective communication between departments and maintain an environment of continuous improvement.