Associate Executive, 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 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