Senior QC Executive

• Ensure all protocol of analysis (POA) / test protocols (TP) for FG testing and raw material; and SOP/ WI used in QC laboratory are valid and effective.
• Assist in review the POA /TP for FG and raw material which prepared by QC Executives before final review by QC Manager / Assistant QC Manager
• Assist in review the analytical method validation (AMV) protocol and report conducted by TS/R&D (FG and raw material) chemical testing before final review by QC Manager
• Assist in review the analytical method transfer (AMT) protocol prepared by TS for FG and raw material chemical testing before final review by QC Manager / Assistant QC Manager
• Responsible in preparing the AMT report upon completed the method transfer form TS (Transferring unit) and to report any discrepancy or variance from the activities.
• Well understand on how to evaluate and review the monograph method which then to be translate into in-house POA / TP for FG and raw material routine testing.
• Involve and support in correspond any regulatory enquiry with regards to FG and raw material testing and POA/TP; Assist the QC Manager/Assistance Manager to prepare the commitment / justification letter for any variation registration or any correspondence/ notification requested from authorized registration countries (as when needed)
• Assist in monitoring the laboratory and its activities safe operation of equipment and to be in strict compliance with GLP by ensuring proper maintenance of laboratory equipment in good working order, timely replenishment of primary reference standard, standardization of secondary reference standard and standardization of volumetric solution, informing laboratory personnel of correct procedure in handling hazardous chemical, providing the necessary safety tools and gadgets and proper supervision of experiments.
• Contact person for any relevant issue in analytical and safety of laboratory
• Lead on the feasibility study for new raw material testing introduce in QC Laboratory which include prepare the protocol, and reports before the method included in the POA/ TP.
• Lead the lab personnel for any related matters for software application issues (such as integration of chromatogram, create project, create report template, create method, lost connection issue), analytical trouble shooting which related to analytical reagent preparation, calculation.
• As part of main person in investigation of any OOS, deviation related to QC testing.
• Responsible to ensure all laboratory equipment calibration and preventive maintenance are updated and notify the person in charge for further action.
• To participate actively in self-inspection programmers organized by QA department
• In charge inventory for chemical used in QC laboratory. Ensure all chemicals are within the expiry date and ensure the chemical available in all time for operation support testing.
• Responsible to lead and advise the execution of laboratory equipment & apparatus used in QC laboratory
• In the absence of QC Manager & Assistant QC Manager, to carry out all managerial works related to registration documentation and full observation on the related section operation & management.
• To review any other related document with regard with laboratory documentation section
• Responsible to lead and advise all QC team which related to analytical testing and QC chemical laboratory matters.

Job Requirement

• Bachelor of Science (Analytical Chemistry) Honors or equivalent discipline
• Minimum 3 years working experience in this/related field
• Well knowledgeable in GLP and QC laboratory environment.
• Well understand in monograph (BP, USP, EP, etc.);
• Well understand in AMV & AMT concept including assay, identification, related substance, impurities, etc.; and
• Knowledgeable in handling and troubleshooting HPLC & GC (for Open Lab and LabSolutions software)
• Adequate problem solving and analytical skills with demonstrated ability to manage several investigations.
• Ability to effectively plan and organize work activities and prioritize task completion to adhere to schedules and deadlines in stability program.
• Ability to work with multi-departmental team and personnel at various levels in the facility.
• Excellent supervisory skills with the ability to coach and mentor staff in order to develop skills and competencies required to meet business needs.
• Strong interpersonal and communication skills: oral/written and listening.
• Pharmaceutical GMP knowledge.
• Proficiency in Microsoft Office programs.
• Behavioral Competencies:
• Initiative, Commitment, Interpersonal Effectiveness, Productivity, Decision Making.
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of success.
• Take action with great speed and efficiency no matter the task.
• Embrace change with enthusiasm.

Job Type: Full-time

Pay: RM4,000.00 - RM5,500.00 per month

Benefits:

• Free parking
• Meal allowance

Schedule:

• Monday to Friday

Work Location: In person