Job Description

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 Associate Executive, QA (Qualification & Validation) is responsible for planning, executing, and reviewing qualification and validation activities across the facility to ensure compliance with regulatory requirements and company policies.

Key Responsibilities:

Plan, execute, review and support for qualification and validation project throughout the facility including utilities and equipment qualification, process validation, cleaning validation and hold time study. Coordinate with relevant departments to provide support for qualification/ validation activities. Support in-process quality assurance related activities. Prepare protocols, execute and review all necessary data generated from the qualification/ validation activities. To prepare or review APEX documents related to Validation/ Qualification such as but not limited to Validation Master Plan (VMP), Cleaning Validation Master Plan (CVMP). To execute FAT at vendor location. To provide support during external or regulatory authority inspections. Ensure all aspect of qualification and validation adhere to required policies and procedures and ensure compliance to applicable regulatory requirements. Perform other related duties as assigned by reporting manager from time to time based on organizational needs. Maintain and update revalidation/requalification calendar. Prepare or review Standard Operating Procedure. Recommend qualification and validation strategies, priorities and resources to ensure meet required timelines. Provide support during internal, external or regulatory authority inspections. Ensure all aspect of qualification and validation adhere to required policies and procedures and ensure compliance to applicable regulatory requirements. Provide support/ execute activities related to Quality Management System such as but not limited to change control, deviation, failure investigation etc. Support in reviewing batch related document such as batch records, scale up protocol/ report, etc. Perform other related duties as assigned by reporting manager from time to time based on organizational needs. To support review of drawings and layouts for equipment and manufacturing facility.

About you

Candidate must possess at least a Bachelor's Degree, in Science (Chemistry, Pharmaceutical Technology, Biotechnology). Preferably fresh graduates with good academic records or with 1 year of relevant working experience in Pharmaceutical Manufacturing. 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 RM2,250.00 per month

Ability to commute/relocate:

Bandar Baru Enstek: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):

Please state the length of notice period (if any). Please state your salary expectation.
Work Location: In person