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Jobs or company...
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Executive, Quality Assurance (Vendor Qualification)

RM 3,200 - RM 4,000 / 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 role will be responsible for execution of the day-to-day Vendor Qualification Quality Assurance activities at Novugen Oncology Sdn Bhd.

Key Responsibilities:-

  • To perform vendor qualification for all raw material and primary packaging material.
  • To perform outsource service qualification for all contract services.
  • To assist and support the vendor audit.
  • To coordinate the vendor complaint with closure.
  • To register Manufacturer Part Number (MPN) in SAP system.
  • To coordinate with auditors to review and close the audit report and follow up with vendor for closure of corrective action and preventive action plan.
  • To prepare and review the Vendor Master List (Approved/ Provisionally Approved) for API, Excipients, and Packaging Material.
  • To prepare a Quality Technical Agreement for vendor of API, Excipient, PPM, and outsource services.
  • To prepare and monitor the periodic performance of vendor as per yearly schedule.
  • To prepare requalification yearly schedule and review the documentation.
  • To participate and provide support during external and regulatory authority inspection.
  • To prepare or review Standard Operating Procedure (SOP) that related QA department.
  • To review and monitor overall activities related to QMS such as change control, deviation, corrective action and preventive action, Quality Risk Management, Annual Product Quality review, Market complains, Product recall, etc.

About you

  • Candidate must possess at least a Bachelor's Degree, in Science (Chemistry, Pharmaceutical Technology, Biotechnology).
  • Minimum 1 year of working experience preferably in Pharmaceutical Manufacturing/ Medical Device industry.
  • Fresh Graduate with relevant internship experience are welcome to apply.
  • Proficient in Microsoft Office Suite.
  • Able to work in shift.
  • Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Job Type: Full-time

Pay: RM3,200.00 - RM4,000.00 per month

Schedule:

  • Monday to Friday

Application Question(s):

  • How long is your notice period?
  • How much is your expected salary?

Education:

  • Bachelor's (Preferred)

Experience:

  • Pharmaceutical Manufacturing Industry: 1 year (Preferred)

Work Location: In person

Expected Start Date: 04/07/2025