Responsible for preparation, review, revision, control, and implementation of standard operating procedures of packing department. Responsible for preparation & review of the master documents of packing. Responsible for preparation and review of Protocols and reports based on the requirements. To assist the officers and Executives for document management and preparation like BPRs master SOPs etc.. Responsible to identify training needs and impart training of SOPs and developmental training within the department and for another department. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. To assist the packing officer for line clearance activity before commencing the operations like labelling and packing operation. To have good communication skill to avoid misunderstanding. Arrange to send requisition in advance to the store get the material required for the next day production plan. Responsible to monitoring of all the activities related to packing. Responsible to give proper planning to subordinates and ensure its implementation. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to helpful all the types of validation, calibration, and verification. Responsible to check all the record and logbooks related to packing area. Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to keep area updated with all the document and cleaning. Responsible to provide guidance to subordinates. Responsible to be fully familiar with machine and activities in his work.

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..

Responsible to attend the training as per schedule and to ensure the training and work as per TNI. Responsible to perform and monitoring all the activities related to Aseptic area. Responsible to follow the preventive maintenance schedule of machines, instruments and equipment’s of area. Responsible to ensure the cleaning and sanitization of machines, instruments and equipment’s and area. Responsible for line clearance activity before commencing the operations, CIP and SIP of Filtration Vessel Responsible to operate the machines :Vial Filling Machine, Vial Capping Machine. Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area. Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area. Responsible to fill the log of area as per SOP and work execution. Responsible to ensure UAF working in area. To follow the cGMP, Good Document Practice and discipline in the department Qualification Requirement: ITI/ Diploma in Mechanical Engineering Exp.: 3-7 years Skilled Operator required for Machine Operation of Vial Filling Machine and Vial Capping Machine Candidate must have experience in the aseptic area for Manufacturing of Injectable Products

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R & D, Quality Unit, Manufacturing, Supply Chain, Marketing team Work Closely with R & D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the Online portal i.e. Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication.

Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R & D, Quality Unit, Manufacturing, Supply Chain, Marketing team Work Closely with R & D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the Online portal i.e. Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication.

Responsible to attend the training as per schedule and to ensure the training and work as per TNI. Responsible to perform and monitoring all the activities related to Aseptic area. Responsible to follow the preventive maintenance schedule of machines, instruments and equipment’s of area. Responsible to ensure the cleaning and sanitization of machines, instruments and equipment’s and area. Responsible for line clearance activity before commencing the operations, CIP and SIP of Filtration Vessel Responsible to operate the machines :Vial Filling Machine, Vial Capping Machine. Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area. Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area. Responsible to fill the log of area as per SOP and work execution. Responsible to ensure UAF working in area. To follow the cGMP, Good Document Practice and discipline in the department Qualification Requirement: ITI/ Diploma in Mechanical Engineering Exp.: 3-7 years Skilled Operator required for Machine Operation of Vial Filling Machine and Vial Capping Machine Candidate must have experience in the aseptic area for Manufacturing of Injectable Products

Understanding of product development related activities of all injectable dosage forms for regulated market. Exposure to injectable dosage form which includes exposure in development of complex injectable products like suspension-based formulation, liposomal formulations, Polymer based products etc. Experienced in preparation and review of product development report, MFR, stability protocol and other study protocols and SOP etc. Basic understanding of implementation of QbD principles for formulation and development (QTPP/CQA/CPP/CMA, risk assessment and control strategy etc.) Effective co-ordination with different departments like regulatory affairs, manufacturing warehouse, quality assurance, quality control and engineering etc. for execution of scale up and exhibit batches. M.Pharm (Pharmaceutics) 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.

Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC, IC and GC etc. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and ICP-MS etc. Check and perform the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound and Residual solvents etc. To coordination with ARD-Development, QA and QC Ensure timely completion of validation/verification and method transfer as per timeline To be able to perform the Daily calibration all instruments/equipment's as per respective schedule. To be able to perform the periodic calibration, Maintenance of all instruments/equipment's as per respective schedule. To be able to perform the daily temperature monitoring of Freeze and Freezer To be able to maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records To be able to review stability chambers data and print outs. M.Sc. / M. Pharm 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 Need to have good understanding of the D & C Act, CDSCO Guidance for Industry, ICH Regulations and NDPS Acts. Strategize, submit and Obtain approvals from CDSCO i.e. FORM 11, CT 17, CT 04, CT 21, CT 18, Form 10, MD 5, MD 6, MD 17, MD 15, Dual NOC in timely manner. Strategize, submit and obtain approvals from State FDA i.e. Test license, Manufacturing license, Export/Domestic License, COPP, FSC, Loan License, WHO GMP, State GMP/GLP. Strategize, submit and obtain approvals from CBN i.e. Export Authorizations and Import Authorizations. Additionally, must have knowledge about FSSAI registration and licenses. Ensure that regulatory strategies are implemented, timely review and alignment with CFTs including R & D, Quality Unit, Manufacturing, Supply Chain, Marketing team Work Closely with R & D, Quality Unit, Manufacturing, Supply Chain & Logistics in providing regulatory inputs during product development to clearly communicate the regulatory requirements for securing the necessary licenses/approvals in India and for global submissions. Well versed about the Online portal i.e. Sugam, NSWS, IDML, IFP, Unified CBN and FOSCOS portal. He/She should be able to handle the queries raised by the aforesaid government department. Need to possess good communication. Show more Show less

Key Responsibilities JOB DESCRIPTION Supervisor is responsible for preparation, review, revision, control and implementation of standard operating procedures activity, Change control and CAPA of Sterile manufacturing department Document preparation like CCF, SOP, Investigation, Risk Assessment, Protocol etc. Qualifications Qualification: M.Sc B.Pharm / M.Pharm Experience : 8 - 11 years Show more Show less

Job Description Monitoring of Water consumption and waste water generation. Monitoring and maintaining the record of ETP. Preparation of SOP ( ETP environment monitoring and Operation ) Disposal of treated water to plant and continuous monitoring of TDS of treated water and maintain the TDS of treated water within the limits. Maintaining the Monthly records for GPCB and Environment Auditors i.e. production. Water consumption, waste water generation, fuel and power consumption etc.. Monthly Environment monitoring from third party as per the Guideline. Monitoring of all effluent drain lines including storm drain and all process scrubbers. Coordination with HODs for monthly data (production, water consumption, waste water generation, power consumption and fuel consumption). Maintain First aid boxes at site. DTC activities of EHS function Qualifications B.Sc / M.Sc / PDIS / ADIS Show more Show less

Job Description Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC, IC and GC etc. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and ICP-MS etc. Check and perform the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound and Residual solvents etc. To coordination with ARD-Development, QA and QC Ensure timely completion of validation/verification and method transfer as per timeline To be able to perform the Daily calibration all instruments/equipment's as per respective schedule. To be able to perform the periodic calibration, Maintenance of all instruments/equipment's as per respective schedule. To be able to perform the daily temperature monitoring of Freeze and Freezer To be able to maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records To be able to review stability chambers data and print outs. Qualifications M.Sc. / M. Pharm 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

Job Description Understanding of product development related activities of all injectable dosage forms for regulated market. Exposure to injectable dosage form which includes exposure in development of complex injectable products like suspension-based formulation, liposomal formulations, Polymer based products etc. Experienced in preparation and review of product development report, MFR, stability protocol and other study protocols and SOP etc. Basic understanding of implementation of QbD principles for formulation and development (QTPP/CQA/CPP/CMA, risk assessment and control strategy etc.) Effective co-ordination with different departments like regulatory affairs, manufacturing warehouse, quality assurance, quality control and engineering etc. for execution of scale up and exhibit batches. Qualifications M.Pharm (Pharmaceutics) 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

Job Description Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs. Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record. Qualifications BSc/MSc. Show more Show less

Description JOB DESCRIPTION Manager QC, is responsible for Managing the activities of the quality control laboratory to ensure timely delivery of materials for use in production and releases of finished products from the laboratory as committed, ensure testing of stability samples within structure of timelines identified in relevant SOP, ensure laboratory activities on par with compliance expectations, and provide top notch inter- and intra-department customer service. Essential Functions Manage the day-to-day operations of the Quality Control laboratory including setting and communicating priorities based on the production schedule. Maintain knowledge of the potential impact of Quality Control activities on activities in other departments and effectively communicate this information to the appropriate personnel in a timely manner. Manage/Enforce laboratory GMP systems and ensure that they are adequate, sustainable and are being followed. Update Laboratory Procedures (SOPs) and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed Manage and perform investigation of out-of-specification laboratory results ensuring that all investigations proceed in a logical, orderly and timely manner and that appropriate corrective and preventive actions are identified when necessary, review and approve investigation reports. Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports. Review certificate of analysis to ensure compliance with the specifications. Develop and implement systems to improve laboratory GMP compliance and/or productivity. Make decisions and implement solutions where deficiencies are found. Provide formal and informal performance feedback to direct and indirect reports including disciplinary action when necessary. Provide input on yearly departmental headcount and turnover of tested samples. Provide input on employee development including promotion and salary increase recommendations. Research and propose capital projects for the laboratory. Additional Responsibilities QUALIFICATIONS Education Bachelors Degree (B.Sc) Chemistry or related field - Required Master Degree (M.SC) Chemistry or related field - Preferred Experience 8 years or more in Laboratory related with progressive increase of responsibilities in cGMP/Pharmaceutical environment, including 4 yrs in a Supervisor capacity. Skills Must be precise and consistent in laboratory data interpretations with respect to USP general chapters and applicable FDA guidances, easily trainable, ready to learn, thorough in reviewing and evaluating laboratory data with respect to established specifications. - Intermediate Must have a thorough understanding of analytical chemistry and analytical techniques used in a laboratory setting. - Advanced Must be able to identify and troubleshoot problems arising during the course of execution of approved methods. - Intermediate Must be flexible to adapt to changes in assignment and be ready to accept any work assigned by management. - Advanced Must be well versed with Microsoft office programs, computer literate, and be able to communicate effectively both within and between departments verbally and in writing. - Intermediate Specialized Knowledge Must possess skills in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC) employing different data acquisition software, dissolution, dissolution profile and drug release, disintegration, and moisture determination (Karl Fischer, Coulometric, LOD). Must be able to understand and explain compendial (USP/BP/EP/JP) procedures. Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems. The incumbent must be able to effectively plan and organize multiple tasks with a high degree of complexity in order to complete them in a timely fashion to meet customer needs. Must be able to work in a cross-functional team setting, either as a leader or a member, and with complete understanding of team goals. Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments. Show more Show less

1. Regulatory Compliance: Ensure compliance with all local, state, and central EHS regulations (GPCB, CPCB, MoEF, etc.) Maintain all necessary documentation and statutory records (consents, authorizations, waste management, etc.) Liaison with external agencies (Pollution Control Board, Factory Inspectorate, etc.) 2. Safety Management: Conduct risk assessments (HAZOP, JSA, HIRA) and implement mitigation plans Lead incident/accident investigation, root cause analysis, and corrective action implementation Ensure usage and availability of PPEs and emergency kits 3. Environmental Management: Monitor and control effluent, emission, waste disposal, and energy usage Oversee ETP/STP operations, hazardous waste handling and disposal Drive sustainability initiatives like water conservation, energy audits, etc. 4. Training Development: Conduct regular safety training and toolbox talks for all employees and contractors Drive EHS awareness campaigns, mock drills, and emergency preparedness programs 5. Documentation Reporting: Prepare and maintain EHS KPIs, monthly reports, audits, and statutory returns Conduct internal audits and support external (regulatory/corporate) audits Maintain ISO 14001 ISO 45001 systems compliance 6. Cross-Functional Collaboration: Work closely with production, engineering, HR, QA/QC for implementation of EHS measures Act as EHS SPOC for any new project/modification/change management

Compilation and/or initial review of labeling documents for OSD Injectable for original ANDA and Additional strength submission. Co-ordinate with CFT for involvement and understanding of priorities and filing timelines. Follow-up with respective department to get documents in timely manner and to ensure that all labeling modules are available for submission on time. To be updated with current labeling practices and regulatory guidelines. Initial review of all deficiency query responses related to US Labeling for both OSD and Injectable. To ensure that all labeling modules are available for CR, IR and DRL submission on time. Co-ordination with cross-functional teams as needed to collect required documents for deficiency responses. To compile deficiency responses. To achieve 100% launch readiness for all new products, with zero labeling issues. To ensure most recent and updated labeling has been issued Ok-To-Print. To ensure all printed labeling will be available for launch and on time. To ensure Drug listing of First Launch products after approval. To ensure labeling docs are available on time for successful execution of Site Transfer projects. To ensure labeling docs are available on time for successful execution of Additional Site Transfer activities. Introduction of labeling for Third party. Assist in review of all RLD updates of OSD Injectable. To ensure that all labeling modules are available of RLD update for submission within time. To co-ordinate with supervisor for involvement and understanding of priorities. Initiation/Facilitate Change Control and LRC for all labeling changes. To approve Softcopy (vendor copy), transparency, shade card, First Print. To create Barcode Grade report. To address all annual reportable changes for labeling. To compile labeling templates for Annual Report, PADER, and APQR. Must have knowledge for Safety labeling change Notification. Good hold on Patent and Exclusivity for labeling carve out. Able to work on labeling SOPs.

Responsible to attend the training as per schedule and to ensure the training and work as per TNI. Responsible to perform and monitoring all the activities related to Aseptic area. Responsible to follow the preventive maintenance schedule of machines, instruments and equipment s of area. Responsible to ensure the cleaning and sanitization of machines, instruments and equipment s and area. Responsible for line clearance activity before commencing the operations, CIP and SIP of Filtration Vessel Responsible to operate the machines :Vial Filling Machine, Vial Capping Machine. Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area. Responsible to update on self-hygiene, cleaning sanitization of area, follow SOPs, filled the document, of area. Responsible to fill the log of area as per SOP and work execution. Responsible to ensure UAF working in area. To follow the cGMP, Good Document Practice and discipline in the department

Key Responsibilities: Water sampling and analysis Microbial Limit Test Sterility test Bioburden test Preservative efficacy test Bacterial endotoxin test. Qualification: M.Sc. (Microbiology) Experience: 4-9 years Person should have an experience to perform Microbial analysis

Key Responsibilities: Water sampling and analysis Microbial Limit Test Sterility test Bioburden test Preservative efficacy test Bacterial endotoxin test. Qualification: M.Sc (Microbiology) Experience: 6-9 years Person should have an experience of water sampling and Microbial analysis such as Sterility test, Microbial limit test, Bioburden test, Preservative efficacy test and Bacterial endotoxin test.