Quality Control Operations Specialist

4 days ago


Kampung Baharu Nilai, Negeri Sembilan, Malaysia Novugen Full time

About Novugen

Novugen is a leading healthcare company with over 30 years of experience in the industry. We specialize in venturing into strategic businesses and developing world-class facilities across the globe. Our global presence and expertise empower us to meet complex challenges in delivering hard-to-source pharmaceutical products.

We operate manufacturing facilities in Bandar Enstek, Malaysia, which are the first USFDA-approved facilities in Southeast Asia. We are also vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting stringent regulatory standards.

Our team is united by a shared vision, with talented individuals from diverse backgrounds working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity.

The role of Senior Associate Manager, Quality Control involves overseeing Quality Control activities such as GLP, QMS, and Equipment calibrations/preventive maintenance as well as continuous process improvement programs. Responsibilities include:

  1. To observe and follow all rules, regulations, and procedures available in the QC Laboratory.
  2. Conduct trainings, including new employee trainings in the QC Laboratory.
  3. Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
  4. Maintain laboratory instrumentation required for testing.
  5. Prepare Method validation / Method transfer / Method verification / PQ protocol and report.
  6. Review of test data, calibration data and report any deviations to supervisor.
  7. Usage decision of Raw materials and packing materials in SAP.
  8. Procure chemicals / Standards / Columns and maintain inventory for routine analysis.
  9. Planning of samples (i.e., Raw materials, Excipients, packing materials, In-Process, Finished Goods, Microbiology, Stability, water and miscellaneous samples) for analysis.
  10. Ensure stability samples loading and pull-out as per schedule.
  11. Maintain calibration / preventive maintenance schedule and ensuring activity been completed as per schedule.
  12. Review logbook, work allotment and review of analytical activity.
  13. Conduct investigation and participate in Physio-chemical lab incidents, OOS, OOT, and Deviations.
  14. Initiate and closures of change control/CAPA.
  15. Review and approval of Standard Operating Procedures, validation protocols, and reports.
  16. Review and approval of Standard Testing Procedures and Specifications.
  17. Prepare master Record of analysis (ROA) and User Requirement Specifications.
  18. Review trending on water testing and environmental testing.
  19. In-charge of chemicals, standards and reagent monitoring and inventory in QC Laboratory.
  20. Participate in qualification, calibration of instrument and equipment.
  21. Monitoring the temperature for Incubators, Refrigerator and Cooling cabinet.

About You

  1. Must possess a Degree in Pharmacy, or equivalent. Having master's would be considered a vital asset.
  2. Minimum 10 years' related experience from Pharma, FMCG, and Healthcare industries.
  3. Knowledge of GLP and QMS in pharmaceutical quality control and GMP requirements.
  4. Relevant hands-on experience in handling Quality Control instruments (HPLC, GC, UV, KF, FTIR, etc.) and troubleshooting.
  5. Investigation and proposal of appropriate CAPA's for notifications such as Lab incidents, OOT, and OOS.
  6. Proficient in Handling of Empower software/Skills related to audit trail review of chromatographic and standalone instruments.
  7. Relevant experience on qualification of working standards/reference standards and analytical method validations.
  8. Strong intrapreneurial skills and mindset from start-up to established organization.
  9. Proficient in Microsoft Office Suite.


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