Quality Control Chemist

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 47,000 - 71,000; Full time

Job summary

Xepa-Soul Pattinson Malaysia Sdn Bhd in Malacca seeks a chemist to support QC testing and documentation in a GMP-compliant environment.

The role requires a Bachelor’s degree in Science and at least 1 year of relevant experience or outstanding academic results; membership in the Malaysian Institute of Chemistry is preferred.

You will assist in sampling, testing, data reporting, and ensure ALCOA+ practices are applied across QC activities in a leading pharmaceutical manufacturer.

Qualifications

• Bachelor’s Degree in Science or related fields (minimum).
• At least 1 year of relevant chemist experience; or outstanding GPA 3.8+.
• Membership/Licentiateship of the Malaysian Institute of Chemistry or equivalent is preferred.

Responsibilities

• Ensure compliance with safety rules, GLP, ISO/IEC standards, and GMPs.
• Plan, organize, and supervise sampling, quality inspection, testing and reporting within stipulated time frames.
• Review and release QC documents, data, reports, and certificates as required.
• Assist in Equipment lifecycle activities: qualification, calibration, verification, preventive maintenance.
• Support inventory management of chemicals, standards, consumables, and chromatographic columns.
• Provide briefing/training for new staff and interns on procedures and requirements.
• Maintain ALCOA+ practices in logbooks, time stamping, real-time recording and procedures.
• Investigate non-conformances and assist in investigations and reporting.
• Ensure documentation and related QC data, test methods, results, specifications are up-to-date.
• Contribute to training and qualification of QC personnel and interns as needed.
• Assist in maintaining and updating QC documentation and procedures.
• Support QA and Analytical Technical Service teams as required.

Education

Bachelor's degree in Science or related fields

Job description

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 associate 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.

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).

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.