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.

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 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 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 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.

Design and specify process equipment systems for pharmaceutical manufacturing plants, ensuring alignment with the project goals and regulatory standards (e.g., GMP, FDA, EMA). Select appropriate equipment, considering factors such as material compatibility, process requirements, automation, and cost-effectiveness. Develop equipment specifications, datasheets, and technical documentation for procurement and installation. Having hands on experience for installing isolator-based filling line. Line manufacturer is Bausch + Straubel, Syntegon, Steriline. Lead or support the execution of process equipment projects, including installation, commissioning, and qualification. Develop project plans, timelines, and budgets for equipment-related projects, ensuring the completion of all milestones on time and within scope. Coordinate with external vendors, suppliers, and contractors to ensure timely delivery and installation of process equipment. Oversee the installation and commissioning of new equipment and systems, ensuring smooth integration into existing operations.

Job Description: Extensive knowledge of ANDA & ANDS submission activities and post-approval procedures and related ICH, USFDA and Health Canada related guidelines. API DMF review with respect to complete USFDA regulatory requirement. Thorough knowledge of Solid oral dosage form / Sterile dosage form / complex dosage form / topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects. Ability to assess the dynamic change cases with respect to ICH Quality / post approval USFDA guidance and Knowledge of Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling Finalization of the Annual Report with required submission data as per USFDA guidance and ensuring its submission as per stipulated timeline. High quality review of entire submission package to avoid any major deficiencies for submitted supplements. Having knowledge about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames. Ensure to better management of major supplements submissions and approval process. Coordination with Cross Functional teams for the documents acceptance as per regulatory requirements. Ensure the no delay in submission always keen to adopt all regulatory submission requirements for complete submission. Maintain regulatory information as per current department practice. Having good Regulatory review and communication skills. Having good team management skills 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.

Testing and release of Raw material, packing material and miscellaneous material samples. To maintain reserve sample as per SOP. Preparation of specifications of raw materials, packing material, in process and finished products and stability protocol as per requirement. Preparation of study protocols with respect to laboratory. Sampling of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Preparation of volumetric solutions, reagent solution, working standards and maintain records. To perform water analysis as per specification, SOP and GTP. To maintain daily water analysis trend record. To prepare and maintain Laboratory reagent and volumetric solution as per SOP. To keep neat and cleanliness at workplace and follow the good laboratory practices in the laboratory. Testing and release of in process, finished product, standards, and stability samples. To keep update of instruments logbooks and to record the data in Laboratory Notebook during testing. To perform the calibration, Maintenance of all instruments/equipment’s as per respective schedule. To attain and complete self- training record. Preparation of indents as per the materials/product requirements. To prepare COA of various product/material as per requirement whenever required. Responsible to share the login credentials with new joiners. To ensure that employees in the department are trained as per the function mapping before work. To upload training copy of new/ revised SOP To ensure training and training related activities for the Department. To ensure the regular updating of Ad hoc/Classroom training details in training software. To generate re-training of any SOP for an employee/s as and when required Submit the employee training files to training cell in case any employee left or no longer with the organization. Responsible as a Department training coordinator (DTC) for the QCC Department Initiate AIMS Requisition for creation, modification, removal, addition, or employee inactivation in AIMS Software. Preparation and review of QC related SOPS. Preparation of general test procedures, method of analysis, specification as per requirement of raw material and packaging material. To initiate and review of A) Change controls B) Out of specifications C) Deviations Education: B.Sc., M.Sc., B.Pharma, Total Experience - 2 - 7 Year in QC department of sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.

Description: The role involves ensuring CGMP compliance and supervising overall production activities of manufacturing area of multiple assigned manufacturing lines. Additionally, the position requires reviewing and maintaining online documents. Essential Functions: Responsible for preparation, review, revision, control, and implementation of standard operating procedures . Responsible for preparation & review of the master documents of production . Responsible for preparation and review of Protocols and reports based on the requirements. Responsible for Document management like BMRs, BPRs, Master SOPs etc.. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. Responsible for line clearance activity before commencing the operations like manufacturing, filling, capping & packing operations . To generate general purchase indent for departmental general items. 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 ensure that all equipment’s and lines are in validated and calibrated status. Responsible to follow cGMP, GDP, and discipline in the department and to ensure that all employees follow the same. Ensure the compliance & discipline . Responsible to makeshift schedule . Responsible to check that all the records and logbooks related to manufacturing, filling and sterilization of equipment’s Additional Responsibilities: Responsible to give training to all the subordinates, technicians, and operators of the department. Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance. Responsible to attend the training as per training schedule and to ensure training as per TNI. Education: Bachelors Degree (BA/BS) B. Pharm - Required Master Degree (MS/MA) M. Pharm - Preferred Master Degree (MS/MA) M. Sc. - Preferred Experience: 12 years or more in 12 - 16 Yrs Skills: Specialized Knowledge: Licenses:

Job Description 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 for Filling and Sealing, Equipment Washing and Autoclave, Dispensing, Manufacturing, Garment Washing Qualifications ITI / Diploma / B.Sc Show more Show less

Job Description Maintain and follow the procedure as per SOP in day to day activity of warehouse. Receipt of materials, Physical verification and Preparation of Good Receipt Note in ERP systems and mail to concern user and purchase department. Affix status label (Quarantine) on all received materials and movement as per status updating. To update the record as per cGMP (like cleaning, balance verification, temperature, humidity, dispensing log book etc..) for day to day activities. To coordinate with the production, QCC, QA and Maintenance department for smooth functioning of department relevant activity. Storage of materials as per their storage condition. To transfer the approved Raw materials and Packaging material from the Quarantine area to release area after receiving approved GRN from QC. To perform material retest date monitoring, transfer the material from approved area tender test area, give intimation QC and issuance for resampling. Issuance/ Dispensing of material like Raw/ Packaging /Misc. materials as per BMR/ BPR and Material Requisition slip. To deduct issued material from software and maintenance of stock record. Physical Stock verification as per schedule. Project work related warehouse execution. Review of QMS (quality management system) related document like CCF/Deviation/CAPA etc. Responsible for overall ERP function monitoring and report generation as per requirement. Ensure that all Finished Good Receipts (Transfer) from operation material management are done asper the norms and SOP to be followed by respective working staff for safe material handling, proper storage, temperature condition and documentation. equipment qualification activity. Executing and reviewing of MM department Monthly stock statement forwarding finance. Review of SOP for material management and other department, Raw Material / Packing Materials receipt, storage and issuance, Handling of Finished Goods receipt/issuance and dispatches, Handling of QMS activity, participation in scheduled RQ, Qualification of area and equipment Qualifications Graduate /M.Sc. / B. Pharm / M. Pharm Show more Show less

Job Description Testing and release of Raw material, packing material and miscellaneous material samples. To maintain reserve sample as per SOP. Preparation of specifications of raw materials, packing material, in process and finished products and stability protocol as per requirement. Preparation of study protocols with respect to laboratory. Sampling of Raw material, packing material and miscellaneous material samples and maintain reserve sample as per SOP. Preparation of volumetric solutions, reagent solution, working standards and maintain records. To perform water analysis as per specification, SOP and GTP. To maintain daily water analysis trend record. To prepare and maintain Laboratory reagent and volumetric solution as per SOP. To keep neat and cleanliness at workplace and follow the good laboratory practices in the laboratory. Testing and release of in process, finished product, standards, and stability samples. To keep update of instruments logbooks and to record the data in Laboratory Notebook during testing. To perform the calibration, Maintenance of all instruments/equipment’s as per respective schedule. To attain and complete self- training record. Preparation of indents as per the materials/product requirements. To prepare COA of various product/material as per requirement whenever required. Responsible to share the login credentials with new joiners. To ensure that employees in the department are trained as per the function mapping before work. To upload training copy of new/ revised SOP To ensure training and training related activities for the Department. To ensure the regular updating of Ad hoc/Classroom training details in training software. To generate re-training of any SOP for an employee/s as and when required Submit the employee training files to training cell in case any employee left or no longer with the organization. Responsible as a Department training coordinator (DTC) for the QCC Department Initiate AIMS Requisition for creation, modification, removal, addition, or employee inactivation in AIMS Software. Preparation and review of QC related SOPS. Preparation of general test procedures, method of analysis, specification as per requirement of raw material and packaging material. To initiate and review of A) Change controls B) Out of specifications C) Deviations Qualifications Education: B.Sc., M.Sc., B.Pharma, Total Experience - 2 - 7 Year in QC department of sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role. Show more Show less