Executive, Analytical Quality Assurance

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 Analytical Quality Assurance activities at Novugen Pharma Sdn Bhd.

Key Responsibilities:

• Ensure Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) is in place and facilitate audit requirement for Quality Control.
• To review the Standard Operating Procedures (SOPs), Standard Testing Procedure, Specifications and Record of Analysis related to Quality Control.
• Responsible for conducting the cGMP walkabout in Quality Control & Microbiology Laboratory to ensure Quality Control Laboratory compliance.
• To review and approve all qualification, method validation and method verification documents for Quality Control.
• To review and approve protocol and report for comparable multimedia dissolution profile.
• To review and approve Out of Specification investigation, Out of Trend, Deviation and Laboratory incident and proposed CAPA for Quality Control.
• To review Quality Control Analytical Test Report and Certificate of Analysis.
• To review all documents and Analytical Test results pertaining to Cleaning Validation (CV) / Hold Time study (HTS)/Process Validation (PV) / Exhibit, Scale up and commercial batch.
• Responsible to review the Quality Control related to change control and documents revision.
• 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.
• To participate and provide support during external and regulatory authority inspection.
• To prepare and review the Standard Operating Procedures (SOPs) related to Quality Assurance.
• To provide support in Internal Audit.
• To issue and control distribution of forms and etc.
• To monitor and handle of Reference samples, Control Samples and Test Samples at QA Reference Samples area.
• Perform other related duties as assigned by reporting manager from time to time based on organizational needs.
• Responsible for conducting periodic instrument audit trail review activity. (Empower and standalone instrument)

About you

• Candidate must possess at least a Bachelor's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology).
• Minimum 3 years of working experience preferably in Pharmaceutical Manufacturing/ Medical Device industry.
• Good technical knowledge and exposure in handling Lab Instruments.
• 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: From RM2,700.00 per month

Work Location: In person