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.,
The Chemist GC Analysis is responsible for performing GC analysis and documenting the same in compliance with cGMP, cGLP, EHS requirements, and defined operating procedures. You will be required to properly take over shift operations as per defined procedures as a reliever. In terms of GC Systems & Analysis, you will need to go through requisite procedures, plan and prioritize activities based on the work plan received from the supervisor. It is essential to ensure Cylinder status and GC column fixation and stabilization before starting the analysis. Additionally, you will be responsible for the preparation of system suitability solutions, standard solutions, and test solutions as defined in the procedures. Calibration of GC Equipment, evaluation of system suitability, and submission of chromatographs for review are also part of your responsibilities. You must adhere 100% to cGMP and cGLP practices in line with 21 CFR Part 11 and EHS requirements applicable to the QC laboratory. Timely reporting of abnormalities/deviations to the immediate supervisor/appropriate authorities is crucial. Regarding GC Documentation, you are required to record raw data related to system suitability solutions, standard solutions, test solutions, analytical and calibration results. Live recording of each activity, including instrument logbook, column usage log, working standard/reference standard/impurities reconciliation, is essential. Handing over completed documents to the reviewer/ongoing documents to the reliever is also part of your duties. In terms of GC Maintenance, troubleshooting day-to-day issues with respect to instruments with the support of an in-house service engineer is important. Successful completion of assigned trainings and application of the same at the workplace is also required. The minimum educational requirement for this role is a B.Sc. in Chemistry, while a preferred qualification is an M.Sc. in Chemistry. A minimum of 2 years of hands-on experience on Software and Instruments (Make n Model) is required, with a preference for 4 years of experience. The candidate should be aware of quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies. Competency requirements for this role include functional knowledge on Software and Instruments, analytical thinking, quality focus, and trouble-shooting skills. Behavioral competencies required are attention to detail, proactive attitude, and problem-solving skills.,
Role Overview: 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. Key Responsibilities: - Follow defined procedures for shift operations including Gowning Procedure, raw material indenting, Material Reconciliation Record update, Intermediate material collection, Utilities availability check, raw material verification and charging, production process execution, process parameter recording in Batch Manufacturing Sheet, cleaning and process validation, and Filtration Activities - Adhere strictly to cGMP practices, 21 CFR regulations, and EHS requirements - Maintain Housekeeping, Hygiene, Pest Control, dispense samples to QC, perform packing activity, and dispatch finished material to stores - Report abnormalities/deviations timely to the supervisor/appropriate authority - Record all activities in Batch Manufacturing Sheet and other documents, handover completed documents to Shift Incharge/ongoing documents to reliever - Provide support to plant maintenance staff, coordinate for preventive maintenance, ensure temperature, pressure, humidity, resolve breakdowns, and complete assigned trainings Qualifications Required: - B.Sc. in Chemistry (M.Sc. in Chemistry preferred) - Minimum 2 years of experience in production and quality systems, regulatory and cGMP guidelines, and EHS requirements in Pharmaceutical API companies Additional Company Details: N/A,
As a Team Member in Chemical Research & Development at the Research & Development department focusing on Peptide Synthesis, your role involves performing chemical synthesis of molecules. You will be responsible for process development, process validation, and transfer to production units. **Key Responsibilities:** - Conduct literature search and collect MSDS. - Perform lab experiments and document the results. - Interpret spectral data and maintain documentation of lab experiments. - Manage documents such as patents, literature, and analytical reports. - Engage in discussions with analytical chemists and DQA regarding analytical results and methods. - Monitor and account for chemical usage and raw material availability. - Calibrate lab equipment like weighing balance, pH meter, and driers. - Update immediate supervisor on lab experiments. - Maintain lab notebook and document experimental results. - Ensure availability of solvents, reagents, and indent to warehouse. - Manage effluent generation from lab experiments. - Monitor plant batches round the clock during process validation. - Perform Manual Solid Phase Peptide Synthesis on Medium and commercial scale. - Purify solid phase products and synthesize impurities and reference standards for analytical method development. - Implement safety measures and adhere to Good Laboratory Practices and Laboratory Safety Norms. **Qualifications/ Experience Requirements:** - Education: M.Sc. in Organic Chemistry (Preferred) - Experience: Minimum 2 years of prior work experience in R&D Department of an API manufacturing company. - Competency Requirements: Functional knowledge in Coupling Reagents, Documentation, GLP, safety compliances, Plant scale-up, Solid Phase Synthesis, Solution Phase Synthesis, and Purification. - Behavioral competencies include Results Orientation, Customer Centricity, Collaboration & Teamwork, Problem Solving, Planning, Communication, and Continuous Learning.,
Manager - Project Management Job Description: Determine and define project scope and objectives Develop and manage a detailed project schedule and work plan Collaborate with cross-functional project team and other internal and external stakeholders for project delivery Manage project issues for timely resolution and project risks for effective mitigation planning Manage project resources in an effective and efficient manner Monitor project costs to meet budget based on project scope and resource requirements Monitor project progress, perform critical path analyses & scenario planning and adjust as needed Share project communications to cross-functional teams in a transparent and timely manner to integrate various parts of a project Maintain strong relationship with external customers and own customer satisfaction scores for assigned projects Measure project performance to identify areas for improvement to deliver projects within defined KPIs Provide project updates on a consistent basis to various internal and external stakeholders about strategy, adjustments, and progress Utilize industry best practices, techniques, and standards throughout entire project execution