Quality Control Chemist

Duties and Responsibilities:

1. To ensure compliance to safety rules, Good Laboratory Practices, MS ISO/IEC 17025, ISO9001, ISO13485, EU GMP, PICs/GMP and other applicable Standards in Xepa-Soul Pattinson.

2. To participate in any self-inspections, internal and external audits to assure conformity to the applicable Standards.

3. To plan, organize and supervise sampling, quality inspection, internal or external testing and reporting of the final results is performed as per stipulated time frame.

4. To support any QC testing activities whichever is required and perform QC test reports compilation.

5. To review and release In-coming inspection report, Quality job sheet, Analytical raw data, Analytical report, Certificate of Analysis (if applicable), Stability study (SS) summary and other QC related test reports after due diligence checks for correctness and accuracy.

6. To ensure alertness and readiness on ALCOA+ concepts among the team for example logbooks usage adherence and update, time stamp, on real time recording, adhere to the written and approved procedure and etc.

7. To prepare/ revise/ review any related QC documentation such as QC data, Test method, Test result/ report, Specification, Procedure, Work instruction, Master-list, Method verification and validation protocol and report, Additional study, Data Trending, Regulatory request and etc. (as if required).

8. To escalate to the QC Manager or Analytical Technical Service Manager in the event of Non-conformance, failure, deviation or any abnormalities and participate in investigations and reporting.

9. To assist and support compliance of Equipment lifecycle; Equipment Qualification, Calibration, Verification, Preventive maintenance and obsoletion is performed as per requirement and procedure.

10. To assist in maintaining and supporting in inventory management of Chemical, Reference standards/ Cultures, Consumables, Chromatographic Columns, Lamps and accessories etc.

11. To assist in briefing/ training/ qualification for new laboratory personnel and interns comply to the training needs, requirement and procedure.

12. As an Approval Signatory by Standards Malaysia (if required), and the appointed effective date will be referred to the approval letter from the Standard Malaysia.

Minimum Requirements:

1.     A Bachelor’s Degree in Science or other relevant fields (minimum).

2.     At least 1 year of relevant experience as a chemist; or outstanding academia result of Grade Point Average of 3.8 or above.

3.     Membership/Licentiateship of the Malaysian Institute of Chemistry or equivalent (preferred).