The Shift Chemist at Pharma Manufacturing department is responsible for achieving the desired production yield of pharmaceutical APIs by ensuring all production activities in the shift comply with cGMP, cGLP, EHS requirements, and specified operating procedures. You will be required to properly take over shift operations as per defined procedures. This includes following the Gowning Procedure before entering the pharma area, indenting raw materials from stores, updating balance in Material Reconciliation Record, collecting Intermediate material, ensuring availability of Utilities before charging the batch, verifying and charging raw material quantities, executing production process, recording process parameters progressively in Batch Manufacturing Sheet, participating in cleaning and process validation during batch startup process, and carrying out Filtration Activities. It is essential to adhere 100% to cGMP practices in line with 21 CFR, as well as EHS requirements applicable to the production shop floor. Maintaining Housekeeping and Hygiene in the shop floor area, ensuring Pest Control, dispensing required samples to QC, performing packing activity, and dispensing finished material to stores for dispatch are also key responsibilities. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authority is crucial. You will be responsible for live recording of each activity in Batch Manufacturing Sheet and other records, as well as handover completed documents to Shift Incharge/ongoing documents to reliever. Additionally, providing support to plant maintenance staff for preventive maintenance schedules, coordinating with plant maintenance team to ensure temperature, pressure, and humidity, resolving breakdowns during the shift, and successfully completing assigned trainings are part of the role. The ideal candidate should have a minimum of a B.Sc. in Chemistry (preferred M.Sc. in Chemistry) and at least 2 years of experience in production and quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies. Key competencies required for this role include the ability to understand systems and processes, execution, optimum utilization of resources, attention to detail, teamwork, and problem-solving skills.,
As a Team Member in Chemical Research & Development at the Research & Development department, specifically in the Peptide Synthesis sub-department, your primary role is to perform chemical synthesis of molecules. This involves process development, process validation, and transferring the processes to production units. Your responsibilities include conducting literature searches, collecting MSDS, performing lab experiments, documenting experimental results, and interpreting spectral data. You will also be responsible for maintaining various documents such as patents, literature, and analytical reports. Collaborating with analytical chemists and DQA on analytical results and methods is an essential part of the role. To ensure the smooth functioning of the lab, you will need to account for chemical usage, availability of raw materials, and perform calibration of lab equipment like weighing balance, pH meter, and driers. Keeping track of regular solvents, reagents, and managing effluent generation from lab experiments are also part of your duties. In addition, you will be required to perform Manual Solid Phase Peptide Synthesis of Peptides on various scales, ranging from medium to commercial scale with minimal supervision. This includes purification of solid phase products, CGMP activities, synthesis of impurities, and degradation impurity standards for analytical method development and validation. Safety awareness and implementation are crucial aspects of this role, and you must strictly adhere to Good Laboratory Practices and Laboratory Safety Norms. Continuous learning and staying updated with industry trends are essential for success in this position. To qualify for this role, you should have an M.Sc. in Organic Chemistry and a minimum of 2 years of experience in the R&D Department of an API manufacturing company. Preferred qualifications include 6 years of experience and knowledge of Process R&D and scale-up processes. In terms of competencies, you should have a strong understanding of coupling reagents, documentation, GLP, safety compliances, plant scale-up, solid phase synthesis, solution phase synthesis, and purification. Behavioral competencies such as results orientation, customer centricity, collaboration & teamwork, problem-solving, planning, and communication are also essential for this role. Continuous learning and professional development are encouraged to excel in this position.,
The Shift Incharge in Pharma Manufacturing is responsible for achieving the desired production yield of pharmaceutical APIs. This role involves carrying out production activities, material management, and manpower supervision in compliance with standard operating procedures, quality standards, and safety norms. Key Responsibilities: - Proper takeover of shift operations as per defined procedures - Following gowning procedures before entering the pharma area - Ensuring receipt of raw materials from stores and updating material reconciliation records - Collecting intermediate materials from the designated area - Ensuring availability of utilities before charging the batch - Executing production processes, recording parameters, and ensuring adherence to cGMP practices - Ensuring compliance with EHS requirements on the production shop floor - Conducting filtration activities and maintaining housekeeping and hygiene standards - Ensuring pest control in the shop floor area - Dispensing samples to QC and handling packing activities - Facing audits and supervising shift chemists and casual labor - Reporting abnormalities or deviations to the immediate supervisor - Handling documentation activities including record-keeping and handover - Coordinating with plant maintenance for preventive and shutdown maintenance - Ensuring compliance with temperature, pressure, and humidity requirements - Completing assigned trainings and applying knowledge in the workplace Qualifications and Experience: - Education: B.Sc. (Chemistry) minimum, M.Sc. (Chemistry) preferred - Experience: Minimum 6 years, preferred 8 years in production and quality systems, regulatory guidelines, and EHS requirements in pharmaceutical API companies Competency Requirements: - Functional: Understanding systems and processes, execution, and resource utilization - Behavioral: Attention to detail, teamwork, problem-solving, and supervision This role requires a proactive individual with a strong background in pharmaceutical manufacturing, quality control, and regulatory compliance. The Shift Incharge must demonstrate leadership skills, attention to detail, and the ability to work effectively in a team environment.,