- JOB SUMMARY
Play a role of team leader and responsible for the sections/ areas under his/ her care. Coordinate technical and administrative work such as checking, receiving and registration of samples, sorting of samples to the test areas, arrangement of repeat samples and urgent samples in the various test sections, accurate data entry, generating the reports, and timely delivery of results and reports, without compromising on the quality, accuracy and procedures. Responsible for method validation and method development under his/ her respective area. Manages the manpower allocations under his/ her sections/ areas of care.
2. ESSENTIAL DUTIES
- Ensure the operational responsibilities are performed as required by the QC department KPI or as per sample priority, due date or in a timely manner to which is relevant.
- Ensure the results are checked, plan samples to ensure the results are met on time.
- Decide for repeats arrangement and validate results on time for reporting to meet the turnaround time.
- Plan and manage annual leave among peers and subordinates such that there is always sufficient crew to cover the Lab operational requirement at all times.
- Report to QC Lab Manager/ Supervisor on all matters related to analytical method validation and analytical method development or improvement for existing starting materials and finished products.
- Deputy for QC Manager/ Supervisor to review and approval of checklist and report of the Chemist section.
- Establish, manage, plan, schedule and execute analytical method validation and analytical method development or improvement programs for existing starting materials and finished products following regulatory requirements.
- Establish analytical method validation protocol, execute and prompt reporting analytical method validation reports on timely manner.
- Responsible to establish and manage all the analytical method validation and method development or improvement related documentation system and archival.
- Responsible to review and establish finished product and starting material test procedures, specification and COA in accordance with latest official monographs/pharmacopoeia.
- Responsible to train and qualify QC chemists and lab technician on development or improved analytical methods for existing starting and finished products.
- Direct assistance to the Validation Team in process validation, cleaning and other qualification or validation, in which laboratory testing support is required.
- Lead Lab OOS Investigations in his/ her area of care and produce investigation report
- Participate in troubleshooting laboratory equipment failure and provide proposals for improvements.
- Work towards achieving the QC department KPI.
- Ensure save working environment at QC department.
- Comply and work towards meeting the company's quality, health safety and environment objectives and policies.
3. MINIMUM QUALIFICATION REQUIREMENTS
3.1. Education
Minimum University Degree (with basic background in Science)
3.2. Experience
Minimum 2 years of experience in Laboratory operation and management
3.3. Skills
- Working knowledge of routine and specialized procedures and tests in specified area of specialty (e.g. Analytical Science and Instrumentation)
- Computer literate and possesses good communication skills to allow fluent communication
- Familiar with Microsoft office (Excel) and Power point
- Team player
- Able to perform the job independently
- Possess good planning, coordinating, managing and time management skills
- Able to engage with cross functional team and external stakeholders
- Self-motivated and proactive - Fully committed to improving the lab performance - Improvements / modification to workflow and quality improvement.
-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.
