Oversee daily manufacturing operations of injectable formulations, ensuring adherence to quality, safety, and compliance norms. Drive production planning in alignment with business needs, ensuring optimum utilization of resources (manpower, materials, and equipment). Ensure strict compliance with cGMP, FDA, MHRA, EU-GMP, and other regulatory guidelines. Coordinate with QA/QC, Engineering, SCM, and R&D for seamless operations and troubleshooting. Lead investigations and CAPAs for deviations, OOS, and market complaints. Implement and drive continuous improvement initiatives – lean manufacturing, Six Sigma, Kaizen, etc. Monitor key performance indicators (KPIs) – productivity, yield, downtime, cost efficiency. Manage and develop a high-performing team, fostering a culture of ownership, discipline, and collaboration. Assist in audits – regulatory, customer, and internal – and ensure timely closure of observations. Participate in technology transfers, validation batches, and new product introductions (NPIs). Ensure workplace safety and compliance with EHS guidelines.

PDF processing, QC Check and CTD/ e-CTD compilation for US market Submission Level Publishing for US Market. Archival and life cycle management of the CTD/e-CTD submission. Priority Management. Understand criticality of any given tasks and discuss any identified issues with Team lead/Group lead. Other duties as assigned by Team lead/Group lead. B. Pharm / 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 To review stability chambers data and print outs. To perform the Daily calibration all instruments/equipment’s as per respective schedule. To follow and maintain safety requirement in the laboratory. To attain and complete self- training record. Preparation and testing of standards. To perform the periodic calibration, Maintenance of all instruments/equipment’s as per respective schedule. To initiate and review of a) Change controls b) Out of specifications c) Deviations Preparation of indents as per the materials/product requirements. To maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records. To maintain the working standards, reference standards and their records. To maintain the column management. AMC Agreements of Instrument and Equipment’s with the Respective Vendors To review stability chambers data and print outs. To perform the Daily calibration all instruments/equipment’s as per respective schedule. To maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records. To maintain the working standards, reference standards and their records. Qualifications B. Sc / M. Sc Show more Show less

Job Description 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 general and controlled area & Aseptic area. Responsible to fill the logs, BMRs and documents of area as per SOP and work execution. Responsible for cleaning and sanitization of area as per SOP 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 as per SOP. Responsible to operate the machines, instruments, and equipment’s of area. 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. Responsible to perform all the activities related to general and controlled area. Responsible to follow the preventive maintenance schedule of machine. Responsible for cleaning and sanitization of general and controlled area as per SOP. Responsible to work as per standard operating procedures of sterile manufacturing department, Filling and Sealing, Garment Washing, Equipment Washing and Autoclave. Qualifications ITI / Diploma / B.Sc Show more Show less

Job Description 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. Qualifications B.Sc / M.Pharm Show more Show less

Job Description PDF processing, QC Check and CTD/ e-CTD compilation for US market Submission Level Publishing for US Market. Archival and life cycle management of the CTD/e-CTD submission. Priority Management. Understand criticality of any given tasks and discuss any identified issues with Team lead/Group lead. Other duties as assigned by Team lead/Group lead. Qualifications B. Pharm / 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

PDF processing, QC Check and CTD/ e-CTD compilation for US market Submission Level Publishing for US Market. Archival and life cycle management of the CTD/e-CTD submission. Priority Management. Understand criticality of any given tasks and discuss any identified issues with Team lead/Group lead. Other duties as assigned by Team lead/Group lead.

Amneal Pharmaceuticals is looking for Trainee Officer, Quality Control to join our dynamic team and embark on a rewarding career journey. Assisting experienced employees with their daily tasks and responsibilities Observing and gaining hands-on experience in various aspects of the job Receiving feedback and guidance from supervisors and mentors Completing assigned projects and tasks under the supervision of experienced employees Collaborating with team members and contributing to team projects Demonstrating a strong work ethic, positive attitude, and a willingness to learn and grow

Amneal Pharmaceuticals is looking for Supervisor, Quality Control to join our dynamic team and embark on a rewarding career journey. Good Communication, Supervision, Team Leading Experience supervising/coaching staff Strong analytical skills Assertive, Self Confident and Team player Positive AttitudeTakes pride in their workAbility to work Independentlyleadership skills for getting work done, persuasiveWell Groomed

Amneal Pharmaceuticals is looking for Associate Administrative Assistant to join our dynamic team and embark on a rewarding career journey. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

To perform Machine and area clearance during dispensing, manufacturing and packaging operation. To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in-process samples and to manage sampling aids. To carry out in-process checks, AQL and ANSI Sampling as per respective documents viz. protocol,BMR, BPR, SOPs and other GxP documents. To ensure GMP practices at manufacturing shop floor. To verify raw material dispensing activity. To approve batch coding details during packaging operation. Review of executed batch records and release for next processing stage. Preparation and review of CPV data trend. To perform impact assessment of breakdown memo. To initiate change control, unplanned and planned deviation where ever required. To review area, equipment and cleaning log and to ensure proper labelling. To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records. To perform calibration of IPQA instruments. To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials. To review and approve packaging artworks, proofs and shade cards. To archive executed documents like BMR, BPR, Hold time Protocol etc. To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging. To monitor and record the environmental condition of label control room. To prepare and revise functional SOPs, wherever required. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

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 and 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 portals 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 for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good Documentation recording and updation. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report. Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOP's Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Activities other than in the Job responsibility are to be done as per requirement of HOD. Qualification - B.Pharmacy, M.Pharmacy, M.Sc.

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 and 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 portals 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

Job Description To review stability chambers data and print outs. To perform the Daily calibration all instruments/equipment’s as per respective schedule. To follow and maintain safety requirement in the laboratory. To attain and complete self- training record. Preparation and testing of standards. To perform the periodic calibration, Maintenance of all instruments/equipment’s as per respective schedule. To initiate and review of a) Change controls b) Out of specifications c) Deviations Preparation of indents as per the materials/product requirements. To maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records. To maintain the working standards, reference standards and their records. To maintain the column management. AMC Agreements of Instrument and Equipment’s with the Respective Vendors To review stability chambers data and print outs. To perform the Daily calibration all instruments/equipment’s as per respective schedule. To maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment’s and their records. To maintain the working standards, reference standards and their records. Qualifications MSc. Show more Show less

Job Description Responsible for document management like BMRs, BPRs, master SOPs etc.. Responsible for preparation & review of the master documents of production. Responsible to ensure UAF working in area. Responsible for the handling of change control, deviations, investigation & CAPA, etc. Responsible for line clearance activity before commencing the operations. Responsible to check that all the records and logbooks related to manufacturing, Sterilization, washing and sterilization of equipment’s. Responsible for preparation, review, revision, control, and implementation of standard operating procedures of sterile manufacturing department. Responsible to ensure cleaning and sanitization of General, Controlled & Aseptic area. Inform immediately to department functional head for any observation/disturbance with respect to documents and machines found in area. Responsible for monitoring all the activities related to General, Control & Aseptic area. Responsible for Equipment Washing and Autoclave, Dispensing, Filling and Sealing, Garment Washing, Manufacturing, QMS, Vial washing and Tunnel Qualifications Officer / Senior Officer / Executive / Senior Executive Show more Show less

Job Description Responsible for commercial batch release to market. Responsible for in process Quality Assurance activities. Responsible for In process Quality Assurance checks during Manufacturing, packing operations. Responsible for line clearance of manufacturing, Packing and dispensing activities. Responsible for assurance of cleaning, sterilization and aseptic manipulations of components. Responsible for Sampling of Cleaning Validation & Compilation of the records. Responsible for Sampling & compilation of Process Validation Reports (PVRs) Responsible for sampling and coordination during validation studies (process / cleaning validation). Responsible for routine monitoring of Manufacturing Areas. Good Documentation recording and updation. Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs). Responsible for the routine GMP Inspection & review of Quality Records of other departments. Responsible for monitoring in Aseptic process simulation study. Responsible for Preparation and Compilation of Media Fill Protocol , Report. Involve in Initiation of Change Control ,Deviation and Participate in Failure Investigation. Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas Responsible for preparation and implementation of SOP's Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule. Responsible for personnel monitoring. Responsible to participate in qualification, requalification, area qualification activities. Activities other than in the Job responsibility are to be done as per requirement of HOD. Qualifications Qualification - B.Pharmacy, M.Pharmacy, M.Sc. Show more Show less

Opening for ESG Manager Analyst/Associate, ESG Programs and Reporting, India Responsibilities include: Support internal tracking, measurement, and reporting on global environmental, social and governance programs Administrative support for global data collection efforts in preparation for annual Corporate Responsibility Reporting Serve as on-the-ground liaison for India specific programs, including working with the local Corporate Social Responsibility team to align on global initiatives and with the engineering/operations team on government required environmental reporting Collaborate across functions with multiple stakeholders to consolidate and enhance activities, policies, and procedures in support of existing and new programs Monitor regional market developments, including changing laws and regulations that impact Amneal from a sustainability perspective Support corporate benchmarking/peer assessments for trends and best practices to inform Amneals corporate responsibility strategy Support annual ESG survey/questionnaire submissions (MSCI, Sustainalytics, ISS) Prepare presentations and status updates for management related to ESG/CSR initiatives

KEY ACCOUNTABILITIES : End-to-End Supply Chain Management: Manage the supply chain processes from sourcing, storage, inventory management, to distribution for the India business. F reight & Logistics Management : Oversee the inward and outward transportation of products across the domestic market for Hospital, Ophthalmology, Oncology, CNS, and Diagnostics Divisions, ensuring compliance with temperature requirements (Minus 20 C, +2 C to +8 C, +15 C to +25 C). Vendor Management: Build and maintain relationships with supply chain partners, ensuring optimal performance and compliance with SLAs. Team Leadership: Lead and mentor a team that handles customer code creation, Goods Receipt Note (GRN), material movement, and related operations. Demand Review & Inventory Management: Collaborate with key stakeholders to manage inventory levels and demand forecasts to prevent stockouts or excess inventory. CFA & Warehousing Operations : Oversee the management of CFAs (Carrying and Forwarding Agents) and warehousing operations to ensure efficient product movement and storage. Super Stockist Operations: Manage and optimize operations with super stockists for product distribution. SOX Compliance: Ensure adherence to Sarbanes-Oxley (SOX) control regulations within the supply chain function.

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 and 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 portals 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.