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Process Assistant, Production

  • Full Time, onsite
  • Oncogen Pharma (Malaysia) Sdn Bhd
  • Bandar Baru Enstek, Malaysia
Salary undisclosed

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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, impacting lives across the world. Together, we are shaping the future of healthcare and changing lives everywhere. About the role The Process Assistant is responsible for operating and maintaining production dispensing/granulation/compression and packing machinery, ensuring compliance with SOPs, GMP, and safety guidelines. The incumbent must be able to perform in-process tests, document records, troubleshoot issues, and meet production schedules. The role also involves assisting with minor machine repairs and adapting to other production activities as required. Key Responsibilities: - Control • To strictly adhere to SOP, GMP and Safety procedures. In any event of any accident, ensure it is reported to the superior and Safety Officer. Training • To ensure relevant training both theoretically and practically (on-the-job) on GMP and SOP procedures are adhered to. Planning/Productivity • To ensure production work floor able to meet the monthly/weekly/daily schedule and given production productivity target. At same time quality assurance guideline must be followed adequately. • To operate, handle and clean the OSD machineries. • To ensure line clearance is completed before starting any process. • To carry out the in-process tests and record the data into BMR. • To troubleshoot the problematic products in given section as instructed by Line Leader or Supervisor. • To perform minor repair of machine under supervision of Line Leader. • To inform Line Leader if encountered machine breakdown event. Documentation • To ensure all the rooms and machines logbooks / cleaning checklists are updated on-time. • To ensure and monitor all the temperature and humidity logbooks are updated on-time. • To ensure BMR / BPR is filled up as per cGMP practices. About you. • Have a Technical Certificates or Diploma in Pharmaceutical, Engineering or equivalent. • Minimum 1-3 years of experience in a manufacturing environment, preferably in pharmaceuticals or a related industry. • Knowledge and experience in adhering to GMP and SOP guidelines in a production setting. • Experience in completing and maintaining accurate production documentation. • Applicants must be willing to do shift work. • Applicants must be willing to work in Bandar Enstek.