Responsibilities -Responsible in review inspect and manage all process related jobs and manufacturing equipment for project Liaise with the supplier for process equipment purchased directly by Oncogen RMG FBD Tablet Compressor Coater Roller Compactor Blister Pack Machine Bin Blender etc Participate in the FAT of process equipment such as RMG FBD Tablet Compressor Coater Roller Compactor Blister Pack Machine Bin Blender Handle the installation testing and commissioning of pharmaceutical manufacturing equipment such as FBD RMG tablet compressor tablet coater and blister packing machine Participate in qualification and validation activities of manufacturing equipment and utility equipment IQ OQ PQ Participate in acceptance test for new water system Distribution System Purified Water System LOOPO cool and WFI hot BWT System if necessary Keeps equipment operational by coordinating maintenance and repair services following manufacturer and rsquo s instructions and established procedures Identify faults investigate production problems and repair equipment quickly and efficiently Work with consultant and rsquo s engineers such as mechanical and civil engineers to ensure all product and system requirement Ensure implementation of HSE Perform other related duties as assigned from time to time based on company needs Requirements -Should have worked in green field projects Excellent in using engineering software such as AutoCAD and Primavera Excellent in checking and reviewing the technical designs and drawings to ensure that they are followed correctly Excellent in providing technical advice and solving problems on site Good in handling and solving the problem or issue arise with minimal supervision Excellent team player and have a good communication skill Able to converse in English and Malaysia national language Candidate must be willing to work at our manufacturing site Bandar Enstek Negeri Sembilan
Type : Company job
Role : Senior Executive
Industry : BioTechnology/Pharmaceutical/Clinical research
Salary : Not Disclosed
Oncogen Pharma is a fully integrated research based pharmaceutical company with a global outlook to cancer treatment. Based in Malaysia, it is one of the fastest growing Pharmaceutical company in the country with the largest portfolio of Oncology products under development. Oncogen Pharma has established the most advanced R&D facilities for developing Oncology APIs and formulations for regulated markets. The diversified and qualified technical team of top professionals from different parts of the world have deep experience & exposure of the development of strategic products for global markets.
Oncogen's API and Formulation plants are set-up close to each other on over 8 acres of land in Enstek Park, Malaysia & are designed by international experts following stringent regulatory requirements by authorities across the globe including USFDA, EMA, PIC/S and WHO. These containment by Design (CbD) facility will have capabilities to develop Solid oral as well as Injectable products for regulated & key emerging markets. They can handle multiple potent products at a time which belong to OEB 4 and 5 categories in full containment fashion addressing needs of safety of product, person & environment. These facility are the first QbD based designed high containment facilities with latest technology and advanced machiniries sourced from top-rated manufacturers from across the world.