Job Description

How Will You Make an Impact? Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers How Will You Make an Impact Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . What will you do The incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and the safety regulations. Responsibilities Setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, fully automatic Lyophilizser, Autoclave, parts and vial washers, depyrogenation tunnel, Formulation process, HMI and automatic CIP/SIP processes and inspection and packaging line equipment (e.g. AVIM, labelling and carton machine etc.) as per relevant SOPs and the Batch Record. Responsible for formulation activities of production batches as per relevant SOPs and the Batch Record. This includes formulation and/or dispensing of all the available Drug substance(s) and excipients. Responsible for Parts preparation, washing and sterilization of materials. Responsible for packaging and transfer of the final product to Freezer as per relevant SOPs and the Batch Record. Complete all the relevant training before executing any task all the time and every time. Responsible to perform all the materials and process (SAP) transactions at each manufacturing process steps as per relevant SOPs and the Batch Record. For aseptic operations strictly follow aseptic techniques and practices practice as per relevant SOPs. Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area as per relevant SOPs and the Batch Record. Perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g. bioburden sampling, water sampling). If applicable, perform chemical and physical tests during the processing of the batch (e.g. pH testing). Timely completion of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice). Transfer materials for manufacturing a batch as per relevant SOPs and the Batch Record. Prepare filters for test execution and perform FIT (filter Integrity testing) as per relevant SOPs and the Batch Record. Provide for the loading/unloading of the loads/batch from the equipment during production activities as per relevant SOPs and the Batch Record. Perform stock check of consumables and inform Manager/Lead technician for required materials. Follow safety and quality compliance at all times and communicate in a timely manner to the superior if any anomalies are observed. Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable. Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician. Any other duties as and when assigned by the Manager. If required, perform Microbial sampling and swabbing of room and equipment. Liaison external vendors for instrument calibration and maintenance. If required and depending on product requirement, perform chemical and mathematical calculations to determine product potency and endotoxin levels for each batch formulation. Perform visual inspection, labeling and packaging on finished drug products. Perform in-process sampling on semi-finished drug products. Conduct in-process inspection and checks. How will you get here Education Minimum 'O' Level, NITEC/ITE education/Diploma in relevant field. Experience 3 to 5 years of relevant experiences in pharmaceutical industry. Clean room with sterile or aseptic processing knowledge and experience. Knowledge, Skills, Abilities Good understanding of safe working practices and cGMP. Highly motivated to work in pharmaceutical Industry. Able to work as a team. Able to work rotating shift.