Process Technician, Production

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 API to 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 2025, 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 The Process Technician, Production will be handling few critical equipment with 21 CFR Part 11 compliance namely Granulation Suites, Fluid Bed Processor (Drying, Top Spray and Wurster Bottom Spray process), Roller Compactor (Dry Granulation process), Compression (in specific Fette 3030P and Bilayer Tablet Compress process), Coating, Encapsulation, Blister Packing, Bottle Packing and Serialisation machine in USFDA - GMP plant environment. The incumbent must be well experienced in GMP Pharmaceutical Oral Solid Dosage ecosystem and has a strong credential in completing task as per schedule, meeting target throughput and desired product quality. He or she shall have experience in facing USFDA auditor and able to deliver at compliance state of the equipment at all time. The incumbent will be responsible for direct reports (team of executives and Manager) who will be the conduit for product development cycles, process improvements and overall operational excellence within the production work of scope. Key Responsibilities: - • Responsible to perform daily production activities in the plant in compliance with current Good Manufacturing Practice (cGMP), regulatory mandates and quality requirements. • Responsible to prepare and arrange tasks for the Manufacturing Lines and Packing Lines. • Responsible to handle recipe management, operate and perform troubleshooting for the equipment in Manufacturing Lines and Packing Lines in safe and efficient manner. • Responsible to execute manufacturing and packing process, performing required in-process product quality checks, cleaning of equipment, ancillary equipment, change part and facilities, tablet compression tooling and packing change part management and performing line clearance for product/ batch changeovers. • Responsible to operate other Production's equipment or provide assistant as assigned by superior. • Responsible to check and fill-in batch record, logbook, and other documentations with GMP environment. • Responsible to assist with on-the-job training of other production trainees and operators. • Establishes and maintains effective communication with production and cross-functional team. • Responsible to follow safety guidelines at the workplace. About you • Must possess minimum Technical Certificates in Science, Pharmacy, Pharmaceutical, Engineering or equivalent. • Minimum 5 - 10 years’ related experience from Pharma OSD, industry. • Experience in working with OSD and knowledge on other dosage forms shall be an advantage. • Strong technical skills in Compression, Coating and Encapsulation • Possess knowledge on legal and regulatory framework/ inspections, i.e; USFDA • Proficient in Microsoft Office Suite • High in interpersonal skill