Executive/Senior Executive, Engineering Compliance (Quality Assurance)

About us

Novugen is a wholly owned subsidiary company of a UAE-based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast experience in venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. We bring hard-to-source and technology intensive products to the market.

Our manufacturing facility in Bandar Enstek, Negeri Sembilan is the FIRST USFDA approved pharmaceutical manufacturing facility in Malaysia and the only in Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from Finished Products R&D and manufacturing.

The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We strive to innovate new concepts to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity.

Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2026, competing in global markets. Through our passionate teams and continuous investment in R&D, we aim to provide early access to affordable medicine of the highest quality. This is our commitment to change lives worldwide.

About The Role

• Prepare and Review various GMP documents (not limited to) as following:
• Planners for various activities like Preventive Maintenance, Sanitization, Calibration and other related activities.
• Standard Operating Procedures and Protocols.
• QMS documents like Risk Assessment, Change Control, Deviation, CAPA, and Impact Assessment.
• To maintain the breakdown maintenance related documents and records.
• Issuance of various controlled formats for the execution of operation and maintenance related activities.
• Archival of the executed engineering documents in good condition.
• Handover the executed documents to QA as and when required.
• Prepare and maintain the Quality Service Agreements with outsource vendors. Ensure the agreements are in valid state.
• Act as departmental training coordinator and ensure the concerned persons are trained on SOPs as defined in Training Need Identification.
• Coordinate with various cross functional departments for the engineering compliance related activities.
• Prepare the necessary documents for engineering compliance related actions items. This includes (but not limited to) Internal and external audit observations response, CAPA, Change controls, deviation, risk assessment etc.
• Attend the necessary internal and external trainings as and when required.
• Take necessary actions to maintain the better compliance in engineering department by periodic review of the various engineering documents.
• Ensure that the adherence of the various operation, maintenance and calibration schedules to ensure it is carried out within due date.
• Preparation and review QRA, Impact assessment documents, CFT documents etc.
• Perform other related duties as assigned from time to time based on company needs.

About You

• Bachelor's Degree in Engineering or a related discipline.
• 1-2 years of experience for Executive/ 2-3 years of experience for Senior Executive in engineering documentation and compliance within a GMP-regulated manufacturing environment.
• Good knowledge of GMP, QMS, and quality documentation (CAPA, Change Control, Deviation, Risk Assessment, SOPs).
• Familiar with maintenance, calibration, and preventive maintenance planning.
• Strong documentation, coordination, and organizational skills.
• Good communication skills with the ability to work cross-functionally.
• Detail-oriented with a proactive approach to compliance and continuous improvement.

Pay: From RM3,000.00 per month

Work Location: In person