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Jobs or company...
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Executive, Quality Control

RM 3,000 - RM 3,900 / month
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About us

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities 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. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impact lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the role

The Executive, Quality control to be perform the Quality control activities such as GLP, QMS and Equipment calibrations/preventive maintenance, as well as continuous process improvement programs.

**Role is available in both Novugen Pharma & Novugen Oncology Manufacturing Plant

Key Responsibilities:-

  • Assist the QC Manager / Supervisor in the management and administration of the QC Laboratory.
  • Executing the tasks/analysis assigned by the respective supervisor.
  • Performing analysis as per STP/GTP and SOP to produce repeatable and reproducible results.
  • Responsible to verify the safety data sheet (SDS) before execution of any activity as applicable.
  • Preparation of SOP’s / protocol and participation of QC Instrument/Equipment qualifications.
  • Responsible to ensure good documentation practice in all QC documents and ensure real-time documentation completion.
  • Ensure the cleanliness of working area, verification of calibration status, maintenance of workspaces and preventive maintenance status of the instruments before initiating the analysis.
  • Perform the sampling of raw materials, packaging materials and water samples.
  • Perform the analysis of water samples, raw materials, packaging materials, in-process, finished and stability samples as per predefined procedures.
  • ·Responsible for preparation of analytical method transfer / validation / pharmacopoeia method verification protocol preparation and execution and then followed by report compilation and approval.
  • Responsible to perform calibration Instrument’s / Equipment’s as per schedule.
  • Responsible to update calibration / preventive maintenance schedule as on when activity completes.
  • Responsible for working standard qualification and maintenance of working standard / reference standard.
  • Responsible to follow cGLP and cGMP practices.
  • Participate in the investigations such as OOT, OOS, lab incidents and deviations etc.
  • Responsible to ensure chemical inventory and availability of MSDS & COA at laboratory area.
  • Perform other related duties as assigned from time to time based on company needs.
  • Responsible to perform microbiological analysis of Raw Material, Packaging Material, In-process, and Finished Product samples according to current analytical protocols.
  • Responsible to perform media preparation for analysis.
  • Responsible to perform water system analysis and environmental monitoring analysis as per plan schedule.
  • In-charge of chemical and reagent monitoring and inventory in laboratory.

About you

  • 3 to 5 years’ related experience from Pharma, FMCG, and Healthcare industries.
  • Has knowledge of GLP and QMS in pharmaceutical quality control and GMP requirements.
  • Has relevant hands on experience in Handling of Quality control instruments (HPLC, GC, UV, KF, FTIR..). and troubleshooting.
  • Knowledge about Laboratory investigation initiations such as Deviation, OOT and OOS.
  • Proficient in Handling of Empower software/Skills related to audit trail review of chromatographic and standalone instruments.
  • Has relevant experience on qualification of working standards/reference standards and analytical method validations.
  • Strong intrapreneurial skills and mindset from start up to established organization.
  • Proficient in Microsoft Office Suite.
  • Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Job Type: Full-time

Pay: RM3,000.00 - RM3,900.00 per month

Benefits:

  • Free parking

Schedule:

  • Monday to Friday

Work Location: In person

Expected Start Date: 04/07/2025