Responsible for planning and execution of API and intermediates according to pre-approved instructions and raw materials, manpower according to the requirementResponsible for prepare, approve, improvement, continuous review and upgradation of existing production SOPs.Responsible for change controls, deviations / OOS / complaint / OOT, validations, qualifications, calibrations and investigations and evaluations. Trainings and implementing cGMP & Safety, Hygiene in production areas. Responsible for handling of Spray dryer and Homogenizer.Facing the customer audits, regulatory audits and conducting self inspections inter departments New product introduce in the plant and establishment the process for commercial with the help of R & D. Review of technology transfer documents related to production and implement accordinglyResponsible to ensure material handling without spillage and to protect product and deterioration.Involvement in quarterly and Annual product quality review.To Conduct, HAZAOP and Risk assessment of product, system, equipment, item, process as per standard procedure.Ensure Strict adherence to safety, health & environment.Ensure Data integrity
JOB RESPONSBILITIES ON QUALIFICATION OF EQUIPMENT, FACILITY & UTILITIES - QA RESPONSIBILITIES: Ensuring of preventive maintenance of all equipments carried out as per schedule. Review of calibration certificates. Review of all equipment and utilities qualification documents (URS,IQ,OQ and PQ). Review of requalification protocol and reports for all equipments as per schedule. Review of temperature mapping protocol and report as per the schedule. Preparation of product quality review as per SOP. Review of preventive maintenance and calibration schedules and checklist. Issuance, retrieval and archival of registers to respective departments. Line clearance for equipments, clean room area and repacking area during product-to-product change over. Review of Water analysis reports and Microbiology reports. Ensure Data integrity. Conducting trainings. Review and compliance of engineering department and conducting GMP walk through audit. Preparation and review of Standard Operating Procedures. Involving in investigations and review of Deviations and others QMS activities. Involving in Internal audits. Handling of document control system.
Handling of different unit operations like Batch charging, Solvent receiving & Charging, Layer separation, Work up, Distillation & Sparkler filtration, Transfer the reaction mass, Crystallization, Centrifugation, drying, milling, sieving and packing etc. Follow the Instructions as per BMR. Timely completion of Batch as per the Schedule given by department Head / Designee. Raw material cross verification before charging the Batch. To Co-ordinate with QC during batch execution and equipment cleaning to get the analytical report / results. Ensure the cleaning, sanitization as per procedure and recording in document. Follow up of Safety and cGMP during the production. Follow the SOPs during manufacturing process. Good documentation practice & Online entry in BMR and ECR. Updation of usage log, Weighing balance log. Personal hygiene. Prior intimation to Engineering department and QC department for good support. Before handling any raw materials or solvents SDS of respective raw materials should know. Co-ordinate with other production employees for smooth operations. Ensure Data Integrity & Training. Any other work allotted by Head Production / Designee. Desired Candidate Profile 2 -7 years of experience in the chemical manufacturing industry with expertise in Production Planning, Shift Planning, Manpower Handling, Daily Production Planning, Handling, Monitoring & Cross Functional Coordination, Bachelor's degree in Chemistry (B.Sc) or Chemical Engineering (B.Tech/B.E.). Strong understanding of chemical processing techniques and quality control measures.
Pre(Roles and Responsibilities Manage daily production planning, ensuring the timely execution of tasks. Oversee cross-functional coordination for smooth shift operations. Handle manpower effectively, allocating resources efficiently. Monitor and control daily production targets, identifying areas for improvement. Plan and execute shift schedules to meet productivity goals. Follow the Good Documentation Practice and cGMP guidelines during production. Execution of Equipment qualifications. Execution of Production planning, Handling and monitoring unit operations (Reactions, Distillation, Crystallization, Centrifugation, drying, milling, sieving, and packing), Spray dryer (Closed Loop Circuit Spray Dryer) handling and operation. Desired Candidate Profile 5 -12 years of experience in the chemical manufacturing industry with expertise in Production Planning, Shift Planning, Production Supervising, Manpower Handling, Daily Production Planning, Handling, Monitoring & Cross Functional Coordination, Bachelor's degree in Chemistry (B.Sc) or Chemical Engineering (B.Tech/B.E.). Strong understanding of chemical processing techniques and quality control measures.
Responsibilities: Lead and manage the project & engineering department, Develop and implement engineering strategies, policies, and procedures to optimize operational performance and ensure compliance with regulatory requirements. Leading projects and involving cross-functional teams across site as per given timelne with engineering design, considering Safety, GMP and Good quality requirements, Manage the projects & maintenance of pharmaceutical manufacturing equipment, and facilities, ensuring adherence to quality standards and best practices to ensure zero downtime. Oversee repair, and calibration of manufacturing equipment and facilities to minimize downtime and ensure uninterrupted production. Developing detailed project plans, timelines, budgets, and managing project scope. defining project objectives and deliverables. Identify and resolve technical issues, project delays, and other challenges that may arise during the project lifecycle. Co-ordinate with customers, consultants, main/sub-contractors and suppliers on project related work including obtaining confirmation and purchase orders. Assure all completed projects meet customer and quality requirements in accordance with job specifications and scope Stay abreast of industry standards, regulations, and advancements in pharmaceutical projects & engineering to drive innovation and maintain competitive advantage. Provide leadership and mentorship to project & engineering staff, fostering a culture of continuous learning, development and high performance. Monitor and analyze key performance indicators (KPIs) to assess project & engineering department performance and identify areas for improvement. Delegate tasks and responsibilities to appropriate personnel at site during project & engineering work. Develop and implement comprehensive energy management strategies and initiatives to optimize energy consumption, reduce energy consumption, and minimize environmental impact across pharmaceutical facilities. Responsible for effective working of critical utilities like purified water and HVAC Systems installed at site are maintained as per functional /designed and GMP requirement. Ensure to train project & engineering team and minimize breakdowns by following good engineering practices and training the subordinates for the same. Ensure the instrumentations of process, utilities and systems installed at site are calibrated as per the frequency and procedure and are maintained. Ensure the effective planning and implementation of civil activity. building maintenance as per schedule. Review, verification and approval of engineering documents, Change Control, deviations, risk assessment, incident and layouts. Ensure the operation, preventive maintenance and monitoring of electrical & Utility systems/ equipments including DG sets, UPS systems and Transfomer, HT, LT, MCC panels & breakers & UPS. Coordinating with govt authorities for organization statutory requirements such as PCB, Electricity, Factory inspector and Boiler inspector. Ensure data integrity, good engineering practices and good documentation practices in projects & engineering.
Responsibilities: Lead and manage the project & engineering department, Develop and implement engineering strategies, policies, and procedures to optimize operational performance and ensure compliance with regulatory requirements. Leading projects and involving cross-functional teams across site as per given timelne with engineering design, considering Safety, GMP and Good quality requirements, Manage the projects & maintenance of pharmaceutical manufacturing equipment, and facilities, ensuring adherence to quality standards and best practices to ensure zero downtime. Oversee repair, and calibration of manufacturing equipment and facilities to minimize downtime and ensure uninterrupted production. Developing detailed project plans, timelines, budgets, and managing project scope. defining project objectives and deliverables. Identify and resolve technical issues, project delays, and other challenges that may arise during the project lifecycle. Co-ordinate with customers, consultants, main/sub-contractors and suppliers on project related work including obtaining confirmation and purchase orders. Assure all completed projects meet customer and quality requirements in accordance with job specifications and scope Stay abreast of industry standards, regulations, and advancements in pharmaceutical projects & engineering to drive innovation and maintain competitive advantage. Provide leadership and mentorship to project & engineering staff, fostering a culture of continuous learning, development and high performance. Monitor and analyze key performance indicators (KPIs) to assess project & engineering department performance and identify areas for improvement. Delegate tasks and responsibilities to appropriate personnel at site during project & engineering work. Develop and implement comprehensive energy management strategies and initiatives to optimize energy consumption, reduce energy consumption, and minimize environmental impact across pharmaceutical facilities. Responsible for effective working of critical utilities like purified water and HVAC Systems installed at site are maintained as per functional /designed and GMP requirement. Ensure to train project & engineering team and minimize breakdowns by following good engineering practices and training the subordinates for the same. Ensure the instrumentations of process, utilities and systems installed at site are calibrated as per the frequency and procedure and are maintained. Ensure the effective planning and implementation of civil activity. building maintenance as per schedule. Review, verification and approval of engineering documents, Change Control, deviations, risk assessment, incident and layouts. Ensure the operation, preventive maintenance and monitoring of electrical & Utility systems/ equipments including DG sets, UPS systems and Transfomer, HT, LT, MCC panels & breakers & UPS. Coordinating with govt authorities for organization statutory requirements such as PCB, Electricity, Factory inspector and Boiler inspector. Ensure data integrity, good engineering practices and good documentation practices in projects & engineering.
Role & responsibilities 1. To perform day to day assigned activity of R&D project as per plan. 2. Working for multi step synthesis. 3. Setting up reaction and collecting reaction data and analytical data. 4. Setting up Lab reaction for doing optimization of reaction with reference to mole ratio/volume/Time /Temperature and other important process parameters. 5. Doing User test of Raw materials. 6. Doing Chromatographic techniques like TLCs and Column Chromatography. 7. Following and Maintaining of R&D documentation as per GMP. 8. Understanding currently established SOPs and following them. 9. Handling of Lab records and Document. 10.Following and Maintaining of R&D lab to current GMP norms. 11.To train the Officers and Trainees. 12.Following the daily glassware cleaning activity. 13.Following the daily checkup for equipment working condition and calibration status. 14.Following the personnel and lab safety. Preferred candidate profile We are hiring only Male candidate -
Role & responsibilities 1. Preparation of Drug Master File for US, EU and Row countries according to year plan. 2. Preparation and submission of Annual Reports, Amendments and updates to filed DMFs. 3. Preparation and Submission of responses to queries from customer and regulatory authorities. 4. Preparation of Technical information package (TIP) based on customer requirement. 5. Adequacy review of documents required for Drug Master File & TIP preparation like BMR, process validation reports etc. 6. Coordination with R&D, Quality Control and Quality Assurance to collect required documents. 7. Evaluation of impact of changes to the submitted DMF’s. Preferred candidate profile Only API - Industry Experience candidate required.