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 Executive, Packaging Development is responsible to support the execution of technology transfer activities by preparing and reviewing technical documents, assisting in scale-up and validation, and collaborating across functions, ensuring data integrity and compliance with cGMP in pharmaceutical manufacturing.

Key Responsibilities:

Assist to develop, design cost effective and review packaging solutions for products such as Master Packaging Records, considering factors such as product stability, safety and regulatory requirements. Assist to evaluate and select packaging materials that meet pharmaceutical industry standards and regulatory requirements, including considerations for compatibility with drug formulations and container closure systems. Ensure packaging designs comply with relevant regulations and guidelines from regulatory bodies such as NPRA, FDA or others globally. This includes requirements for labeling, child resistance, tamper evidence, and serialization. Implement quality assurance processes to maintain consistent packaging quality, including developing packaging specifications, and implementing appropriate controls. Assist in packaging development projects from concept through to commercialization, collaborating with cross-functional teams including R&D, regulatory affairs, production, and quality assurance. Responsible to maintain accurate documentation of packaging development activities, prepare and review of all packaging development SOPs, specification and STP. Identify and implement opportunities for packaging standardization and automation in order to improve cost. Evaluation of packaging materials and execution of trials. Supporting to cross functional teams to achieve the project timelines. Investigations related to packaging (development and operation) issues. Conducting batches at CMOs (if required) Review of artworks and ensuring the approved artworks feasibility with respect to operations. Support to production for change part qualification. Any other ad hoc tasks assigned by the management

About you

Must possess a Degree in Pharmacy, Packaging, Technology Transfer, or equivalent. Having Master's, MBA, or PHD would be considered a vital asset. Preferably candidate with 2-3 years' related experience from Pharma, FMCG, and Healthcare industries. Has knowledge of pharma packaging requirements and cGMP requirements. Understanding of Pharma packaging components, packaging process, packaging equipment and packaging analytical testing. Proficient in Microsoft Office Suite. Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.
Job Type: Full-time

Pay: RM3,000.00 - RM3,900.00 per month

Application Question(s):

How long is your notice period? (Months) What is your expected salary? (RM)
Experience:

R&D Technology Transfer / Packaging: 2 years (Preferred) Pharmacy/FMCG/Healthcare industries: 2 years (Preferred)
Work Location: In person