Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment’s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc.. Qualification- M.Sc. (Chemistry) / B.E. Chemical / B. Tech Chemical.

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the Job Description are to be done, as per the requirement of HOD, by following HOD’s instructions and guidance. 18 Coordination and management of training activity of Manufacturing department. Experience: 1-2 Years Work on shop floor in Manufacturing area Education: B. Pharma Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Description: Entry level role in the Coating Department. Coating Operator is responsible for safely operating the coating equipment and to ensure Coating Operations are completed in adherence to Standard Operating Procedures and maintaining 100% cGMP & compliance. Essential Functions: Records and maintains the production batch record during the coating operation. Observes machine gauges and equipment calibration status and reports any deviations to Coating Supervisor. Operates auxiliary equipment used in loading coating pans. Cleans and organizes coating room, checks and verifies weight of tablets received from Compression, reports deviation. Weighs and divides coating solution in number of parts as per production batch record. Checks and verifies coating material dispensed by Pharmacy before making coating solution as per production batch record. Additional Responsibilities: Other duties as assigned. Operation and cleaning of all Manufacturing equipments as per current version of respective SOPs. Maintaining the area and equipments in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. Maintaining the tooling and change parts for all equipments at manufacturing. To follow safety rules. To perform all work related to manufacturing as per instructions of assigned officer/executive/supervisor following defined and approved procedures. Material handling as per approved procedure. To get the required training from supervisors for cGMP and concerned SOP for operation and cleaning. To perform work as assigned by superior or department head. Education: High School or GED General HS Curriculum - Preferred/Diploma Experience: 1 year or more in Pharmaceuticals manufacturing experience. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment’s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc.. Qualification- M.Sc. (Chemistry) / B.E. Chemical / B. Tech Chemical.

JOB DESCRIBTION Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation and cleaning. To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record. Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents. To follow all safety rules and departmental general instructions. To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Sr. Executive -Packing B-Pharma Min. 5 year exp. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Job Description Manage operations and maintenance of ETP and STP to ensure compliance with environmental norms. - Ensure adherence to legal and statutory requirements including GPCB, CPCB, DISH, and other applicable bodies. - Lead internal and external EHS audits and ensure timely closure of non-conformities. - Implement EHS programs and SOPs across the site. - Manage hazardous waste handling, storage, and disposal as per regulatory standards. - Conduct safety drills, risk assessments, and training sessions to improve safety awareness. - Maintain accurate documentation for all EHS-related activities and compliance requirements. - Serve as the primary contact for inspections and liaison with regulatory authorities. - Drive continuous improvement initiatives in health, safety, and environmental practices. - Investigate incidents and ensure corrective/preventive actions are effectively implemented Show more Show less

Job Description Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment’s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc.. Qualifications Qualification- M.Sc. (Chemistry) / B.E. Chemical / B. Tech Chemical. Show more Show less

Job Description Key Responsibilities: Conduct routine environmental monitoring and assessments in various locations Collect, analyze, and interpret environmental data using specialized equipment and software Maintain accurate records and documentation of environmental conditions Communicate findings and recommendations to stakeholders and management Participate in environmental remediation and restoration projects Ensure compliance with environmental regulations and standards Qualifications Qualification: M.Sc (Microbiology) Experience: 2-7 years Show more Show less

Job Description JOB DESCRIBTION Supervision of manufacturing, processing, packaging and holding of drug product as per define and approved procedures for stability batches and commercial batches. Maintaining the area and equipment in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. To perform online documentation with respect to departmental procedures as per good documentation. To impart training of operation and cleaning related SOP to all subordinates and operators. Co-ordination for IQ / OQ for any new equipments / system. To perform PQ for any new equipments / system. To follow all concern departmental SOPs for day to day operation and cleaning. To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record / Batch Packing Record. Review, execution and implementation of Batch Manufacturing Records, Batch Packaging Records, Process Study Protocols, Process Study Reports and all relevant Documents. To follow all safety rules and departmental general instructions. To perform work other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Qualifications Sr. Executive -Packing B-Pharma Min. 5 year exp. About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less

Description JOB DESCRIPTION Entry level role in the Coating Department. Coating Operator is responsible for safely operating the coating equipment and to ensure Coating Operations are completed in adherence to Standard Operating Procedures and maintaining 100% cGMP & compliance. Essential Functions Records and maintains the production batch record during the coating operation. Observes machine gauges and equipment calibration status and reports any deviations to Coating Supervisor. Operates auxiliary equipment used in loading coating pans. Cleans and organizes coating room, checks and verifies weight of tablets received from Compression, reports deviation. Weighs and divides coating solution in number of parts as per production batch record. Checks and verifies coating material dispensed by Pharmacy before making coating solution as per production batch record. Additional Responsibilities Other duties as assigned. Operation and cleaning of all Manufacturing equipments as per current version of respective SOPs. Maintaining the area and equipments in orderly manner as per cGMP requirements in a good state of repair and sanitized condition. Maintaining the tooling and change parts for all equipments at manufacturing. To follow safety rules. To perform all work related to manufacturing as per instructions of assigned officer/executive/supervisor following defined and approved procedures. Material handling as per approved procedure. To get the required training from supervisors for cGMP and concerned SOP for operation and cleaning. To perform work as assigned by superior or department head. Education QUALIFICATIONS High School or GED General HS Curriculum - Preferred/Diploma Experience 1 year or more in Pharmaceuticals manufacturing experience. About Us Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion. About The Team The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs. Key Roles That The Human Resources Team Performs Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions. Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures. Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing. Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance. Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market. Show more Show less

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc..

Operate and monitor Solvent Recovery/ API manufacturing equipment and Instrument, such as distillation column, reboiler, condenser, reactor, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production/ solvent recovery activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Solvent Recovery Record (SRR), Equipment s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, and cross-functional teams to ensure efficient and coordinated production/ Solvent recovery. Before charging of batch, cleanliness of Equipment s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, finished products, mother liquor, recovered solvent. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product/ solvent quality and consistency. This may involve sampling and testing intermediates, raw materials, finished products and recovered solvent. To monitor the process/ unit operation online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product/ Solvent specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), Solvent Recovery Record (SRR) and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate s manufacturing, Solvent Recovery and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing/ solvent recovery process, such as equipment malfunctions or variations in product/ solvent quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To plan and procure, evaluate, and control on the inventories of Raw materials/ Packaging materials as per production requirements. To ensure materials receipt/storage/dispensing at Warehouse are done as per defined procedures with refer to respective MSDS and follow safety requirements. To ensure the weighing balances verification/calibration in Warehouse is done as per respective SOP. To ensure environment condition of dispensing area in Warehouse is as per respective SOP. To be performed necessary documentation work during the material dispensing activity as per respective SOP. Responsible for receiving mother liquor/ spent solvent/ layer/ distilled or recovered solvent and residue from production blocks, processing them through distillation for solvent recovery, and ensuring proper dispensing and storage of the recovered solvents as per standard operating procedures. To prepare and review manufacturing department related documents as per requirement.

To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software.

To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software. Qualification : MSC/BE or BTECH Chemical Engineering

Job Description Operate and monitor Solvent Recovery/ API manufacturing equipment and Instrument, such as distillation column, reboiler, condenser, reactor, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production/ solvent recovery activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Solvent Recovery Record (SRR), Equipment’s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, and cross-functional teams to ensure efficient and coordinated production/ Solvent recovery. Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, finished products, mother liquor, recovered solvent. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product/ solvent quality and consistency. This may involve sampling and testing intermediates, raw materials, finished products and recovered solvent. To monitor the process/ unit operation online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product/ Solvent specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), Solvent Recovery Record (SRR) and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing, Solvent Recovery and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing/ solvent recovery process, such as equipment malfunctions or variations in product/ solvent quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To plan and procure, evaluate, and control on the inventories of Raw materials/ Packaging materials as per production requirements. To ensure materials receipt/storage/dispensing at Warehouse are done as per defined procedures with refer to respective MSDS and follow safety requirements. To ensure the weighing balances verification/calibration in Warehouse is done as per respective SOP. To ensure environment condition of dispensing area in Warehouse is as per respective SOP. To be performed necessary documentation work during the material dispensing activity as per respective SOP. Responsible for receiving mother liquor/ spent solvent/ layer/ distilled or recovered solvent and residue from production blocks, processing them through distillation for solvent recovery, and ensuring proper dispensing and storage of the recovered solvents as per standard operating procedures. To prepare and review manufacturing department related documents as per requirement. Qualifications Qualification - M.Sc Chemistry/ B.E Chemical/B.Tech Chemical

Job Description To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software. Qualifications Qualification : MSC/BE or BTECH Chemical Engineering

Job responsibilities of mechanical engineer Plan, coordinate and execute mechanical engineering activities for projects (greenfield/brownfield) Review BOQs, layouts, specifications and ensure installation of HVAC, utilities and cleanroom systems as per cGMP & FDA norms. Collaborate with cross-functional teams – QA, QC, Production, EHS, Maintenance – for seamless project execution and compliance. Monitor project schedules (MS Project), milestones and critical path to ensure on-time delivery. Lead vendor management, contractor supervision and technical review meetings for mechanical systems. Conduct equipment FAT/SAT, qualification protocols (DQ, IQ, OQ) and manage mechanical documentation for regulatory audits. Ensure adherence to safety, quality and statutory norms across all stages of mechanical work. Strong knowledge of HVAC systems, AHUs, Chillers, Compressors, Boilers, BMS, and cleanroom design. Familiar with IS, ASME, and cGMP engineering standards. Proficient in AutoCAD, MS Project/Primavera, and utility design tools. Knowledge of WFI, PW, steam and compressed air generation/distribution systems. Strong cross-functional coordination and leadership. High accountability and ownership of timelines. Detail-oriented, quality-driven, and safety-conscious. Excellent communication, negotiation, and documentation skills. Problem-solving mindset with agility to adapt to changes.

Job Description Job responsibilities of mechanical engineer Plan, coordinate and execute mechanical engineering activities for projects (greenfield/brownfield) Review BOQs, layouts, specifications and ensure installation of HVAC, utilities and cleanroom systems as per cGMP & FDA norms. Collaborate with cross-functional teams – QA, QC, Production, EHS, Maintenance – for seamless project execution and compliance. Monitor project schedules (MS Project), milestones and critical path to ensure on-time delivery. Lead vendor management, contractor supervision and technical review meetings for mechanical systems. Conduct equipment FAT/SAT, qualification protocols (DQ, IQ, OQ) and manage mechanical documentation for regulatory audits. Ensure adherence to safety, quality and statutory norms across all stages of mechanical work. Strong knowledge of HVAC systems, AHUs, Chillers, Compressors, Boilers, BMS, and cleanroom design. Familiar with IS, ASME, and cGMP engineering standards. Proficient in AutoCAD, MS Project/Primavera, and utility design tools. Knowledge of WFI, PW, steam and compressed air generation/distribution systems. Strong cross-functional coordination and leadership. High accountability and ownership of timelines. Detail-oriented, quality-driven, and safety-conscious. Excellent communication, negotiation, and documentation skills. Problem-solving mindset with agility to adapt to changes.

Job Responsibilities: Responsible for maintaining cGMP and Good laboratory practices. Responsible for maintaining General cleanliness of laboratory. Responsible for monitoring of exhibit batch analysis with quality control person. Responsible for preparation of instrument methods, methods sets and review of sample sets processing methods, generated in Empower software. Responsible for Analytical method transfer, method verification and method validation. Involve in Raw material, Finished product and Packaging material analysis. Responsible for preparation and review of protocols for method transfer, method verification and method validation. Responsible for preparation and review of reports for method transfer, method verification and method validation. Review and maintain of reconciliation of electronic data generated in quality control laboratory during analytical method validation, verification, technology transfer, development, feasibility study. Responsible for review of any laboratory incident occurred during method transfer, method verification and method validation activity and prepare the laboratory incident report for the same. Responsible for archival and retrieval of Analytical development documents from QA department. Responsible for overall compliance of Analytical Documents. Records generated in quality control laboratory. Responsible for providing relevant documents for regulatory filings. Responsible to take part in internal & external audit. Responsible for procurement of columns, chemicals, reference standards, impurity standards for analytical method transfer, method verification and method validation activity. Responsible for initiation of change controls, Deviations/Incidents. Responsible for review of specification and STP. Responsible for timely response to regulatory queries. Qualification- M. Sc, M. Pharmacy, B Pharmacy

For aseptic area operation, bag line , vial line Qualification: ITI/Diploma/B.Sc