Work Schedule
Flex 12 hr shift/nights

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse, Will work with hazardous/toxic materials

Job DescriptionPLEASE NOTE: This is a 12-hours rotating shift role
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The incumbent will assist manager to supervise a team to meet production targets/schedules while always maintaining standards of cGMP, safety, and housekeeping. Along with this 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:

• Monitor the production activities and ensure that processes are performing as per process description and SOPs.
• Responsible to complete batch documentation accurately and thoroughly, while adhering to the quality and safety standards, and maintaining a productive, cost-effective process.
• Assist the Production Leader in the day-day production activities. Approve the required production cycles.
• Assist and ensure optimum allocation of personnel and equipment. Liaison with associated departments for day-day issues.
• Report and assist to investigate quality deviations.
• Assist in troubleshooting of related quality deviations and resolving problems that arise during the processing.
• Ensure correctness of completed batch sheets and the timely submission of the same.
• Ensure adherence to cGMP and GDP (Good Documentation Practice).
• Approve and closeout safety work permit.
• Provide oversight during preventive and breakdown maintenance. This includes providing Operations oversight of CM/PM/Calibration activities in the production area.
• Lead Continuous Improvement activities as assigned by manager to improve Quality as well as Efficiency.
• If required, setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, 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.
• If required, perform 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.
• 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.
• If required, carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area as per relevant SOPs and the Batch Record.
• If required, perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing (e.g. bioburden sampling, waler sampling). If applicable, perform chemical and physical tests during the processing of the batch (e.g. pH testing).
• If required, prepare filters for test execution and perform FIT (filter Integrity testing) as per relevant SOPs and the Batch Record.
• 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.
• If required and depending on product requirement, perform chemical and mathematical calculations to determine product potency and endotoxin levels for each batch formulation.
• Any other duties as and when assigned by the Manager.

Requirements:

• Minimum “O” Level, NITEC/ITE education/Diploma in relevant field.
• Minimum 5 years of relevant experiences in pharmaceutical industry.
• 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.