Executive, Quality Control

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 eight 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 the 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, impacting lives across the world.

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

About the role The Executive, Quality Control will oversee Quality Control activities such as calibration, verification and standardization and comply with GMP, GLP procedures and other regulatory requirements.

Perform analysis as per SOP and STP to produce repeatable and reproducible results.

Verify the safety data sheet (SDS) before execution of any activity as applicable.

Preparation of SOPs / protocol and participation of QC instrument / equipment qualifications.

Ensure the cleanliness of the working area, verification of calibration status, maintenance of workspaces, and preventive maintenance status of the instruments before initiating the analysis.

Management of chemicals, HPLC and GC Column, reference standard and working standard as per the SOP.

Perform sampling and 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 / pharmacopeia method verification protocol and execution, followed by report compilation and approval.

Perform calibration instruments / equipment as per schedule and update preventive maintenance schedule when activity is complete.

Responsible for working standard qualification and maintenance of working standard / reference standard.

Participate in the investigations such as OOT, OOS, laboratory incidents, and deviations.

Responsible to ensure standard inventory and management for laboratory usage.

About you

The candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree in Chemistry, or equivalent.

Ideal to have at least 1 year of working experience as Chemist / QC in the pharmaceutical industry but fresh graduates are encouraged to apply!

Experience in QC analytical activity, in-process, finished product & stability, sampling and testing raw material and method validation, and verification.

Knowledge of QC instruments, like HPLC, GC, UV Spectrophotometer, KF, particle size analyzer, etc.

Good understanding of chemical analysis, dissolution, disintegration testing and stability activity.

Excellent team player and good communication skills

Familiar with Good Documentation Practice (GDP), Good Manufacturing Practice (GMP), and Good Laboratory Practice (GLP) requirements.

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