Job Description Responsible for document handling, issuance, distribution, and retrieval of docume,verification of documents like Batch Manufacturing records, Batch Packaging Records, Protocols, layouts, specifications, Method of Analysis, Logbooks, Planner, etc. Responsible for issuance of approved Standard Formats and Logbooks to User Departments, Issuance of line-clearance checklist, interventions checklist and additional pages of BMR/ BPR as requested by user, reconciliation, retrieval and archival of issued standard formats and logbooks. To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Qualifications B.Sc / M.Sc / B.Pharm / M.Pharm

Job Description To handle and distribute various samples received for microbiological analysis. To maintain the logbook for the same. Maintain housekeeping of Microbiology lab. To maintain the inventory of various microbiological media, maintain log and status labels, media preparation, growth promotion test and reconciliation of media. Microbial culture handling and inoculum preparation. Water sampling and analysis of water samples as per schedule, with completion of all reports and records. Responsible for Sterility testing, Bacterial endotoxin testing, antibiotic microbial assay and bio burden testing of Raw material, in-process, finished products. Environmental monitoring of microbiology lab clean room area as per the defined schedule. Non-viable particle monitoring of microbiology lab clean room area as per the defined schedule. Responsible to identify and maintain data logging of EM Isolates. To perform disinfectant efficacy testing as per SOP. To perform microbial identification as per defined schedule. Responsible for handling and testing of biological indicator. To perform CCIT test of post media fill units. To perform observation of microbial plates exposed in manufacturing area. To perform media fill unit observation as per SOP. Responsible for reporting any OOS, Deviation to In-charge. Responsible for preparation of standard operating procedures of microbiology department. Responsible to co-ordinate with manufacturing, Engineering, and other QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Responsible to participate in perform qualification activities of manufacturing and Microbiology area. Responsible for Compressed air /nitrogen gas monitoring and Personnel monitoring Preparation of indents as per the materials/product requirements. To initiate and review of a) Change controls b) Out of specifications c) Deviations. To attain and complete self- training record. Preparation of study protocols with respect to laboratory. Review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Preparation of COA. To keep neat and cleanliness at workplace and follow the good laboratory practices and safety related instruction in the laboratory. To perform water analysis and maintain daily water trend. Sampling, testing and release of Raw material, packing material, miscellaneous material samples and in process sample and maintain reserve sample as per SOP. To keep update of instruments logbooks and to record the data in Laboratory Notebook / and respective software. To monitor and plan the activities of various glassware and items required for microbiological analysis with respect to their cleaning, sterilization, and dehydrogenation. To maintain log and status labels for all such items and reconciliation record. Responsible for Pure culture handling and maintenance. To maintain daily logs of area with respect to temperature, humidity, differential pressure, area cleaning, disinfectant preparation, etc.. To record such reading in the respective records and logs. Qualifications B.Sc. to M.Sc.

Job Description Responsible to participate in perform qualification activities of manufacturing and Microbiology area Responsible for Compressed air /nitrogen gas monitoring and Personnel monitoring. Planning and execution for environmental monitoring of manufacturing and microbiology lab clean room area as per the defined schedule Planning of compressed air /nitrogen gas monitoring and personnel monitoring. To perform calibration/qualification of instruments/equipment as per predefine schedule. Responsible to participate in media fill simulation study. Handle sterility testing, Handling of microbial identification, Handling of bacterial endotoxin test Qualifications Qualification: B.Sc./M.Sc./B. Pharm

Job Description Person having minimum experience of analysis and processing of In process and Finished product and handling of HPLC,UV,FTIR,K/F,AAS,IC,Dissolution (Sotax) and other instruments Qualifications Qualification: Master's degree preferred (M.sc/ M.pharm / B.Pharm) Experience: 2-4 years Person having minimum experience of analysis and processing of In process and Finished product and handling of HPLC,UV,FTIR,K/F,AAS,IC,Dissolution (Sotax) and other instruments

Walk-in Drive @ Ahmedabad on 18th May'25 (Sunday) for Quality Control Department We are looking for suitable candidates for OSD Quality Control for Ahmedabad location Unit Interview Venue Details: Date: 18th May 25 (Sunday), Time: - 9:00 AM to 1:00 PM Venue : Amneal Pharmaceuticals Pvt. Ltd Survey No. 634,637-641 Village: Rajoda Tal: Bavla Dist: Ahmedabad -Gujarat - 382220 1) REQUIREMENT FOR OSD QUALITY CONTROL DEPARTMENT Total Experience: 02 to 7 years (Pharma experience only) Qualification: B.Sc./ M.Sc/ B. Pharm/ M. Pharm Designation: Officer/ Sr. Officer /Executive/ Sr. Executive Department: Quality Control Desired Profile: Test RM, PM, in-process, finished & stability samples (various dosage forms i.e., tablet, Capsules, oral suspension/ ointment/powder etc) as per SOPs/pharmacopeia Operation of HPLC, GC, UV, FTIR, Dissolution, KF, wet & physical tests Troubleshoot basic issues Ensure ALCOA adherence in shift activities Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP and understanding of regulatory requirement will be preferred. Note : Candidate should relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliant) organization. Kindly carry your updated CV along with copies of CTC proof, Appointment letter, Increment letter, last 3 months salary slips, Bank statement, Education certificates & Marksheets, Aadhar & PAN card and passport size photograph, at the interview venue. Disclaimer: Beware of fake job offers claiming to be from Amneal Pharmaceuticals Pvt. Ltd. or Companies under Amneal Group (collectively referred to as AMNEAL). Amneal neither send job offers from free email services like Gmail, Rediffmail, Yahoo mail, Hotmail, etc. nor charges any fees/security deposit from any job seekers. Amneal will not be responsible to anyone acting on an employment offer not directly made by Amneal. Stay vigilant and report any suspicious activity to Amneal.

Job Description Responsible for line clearance activity before commencing the operations. To follow the cGMP, Good Document Practice, and discipline in the department. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in visual inspection and Packing area. Responsible to follow the preventive maintenance schedule of machine. Responsible to attend the training as per schedule and to ensure the training as per TNI Responsible to all packing related activities. Responsible for cleaning and sanitization of visual inspection and Packing area. Responsible to operate the machines Responsible to work as per standard operating procedures of sterile manufacturing department. Qualifications ITI / Diploma / B. Sc Show more Show less

Job Description To co-ordinate with the SCE/ production team for the ongoing commercial requirement and to ensure the deliveries for launch and commercial Secondary packaging material timely PO creation for all secondary packaging materials for all sites and Primary packaging material of OSD To handle the Artwork activity and to share the tracking file with CFTs regularly. To have weekly meetings with respective plant team and SCE to track the deliveries and identify the bottle neck issues Preparation and submission of delivery report and to short close the open older POs/ Indents To deal with the excise team for queries and issuance of excise related documents required for procurement, if needed Regular vendor meetings and price / payment term discussions for secondary Packaging materials To create the new item code/ modify the item codes. To approve the destruction note for expired/ rejected materials. To access the CCF for printed packaging material along with raising CCF for Misc. items. To prepare and share Lead time/ MOQ files for PM components Supporting finance team for Audit queries, standard cost etc. 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. Show more Show less

We are hiring for a Green Field Projects at Amneal , Ahmedabad. Following is the JD : Key Responsibilities : Lead QA operations related to Qualification & Validation, including Cleaning Validation, Process Performance Qualification (PPQ), and Computer System Validation (CSV). Develop and implement Validation Master Plans (VMP), Contamination Control Strategies, and Quality Risk Management (QRM) frameworks. Ensure qualification and validation of manufacturing equipment, utilities, and computerized systems to meet regulatory requirements. Drive regulatory inspection readiness, acting as SME for audits including USFDA, EMA, ANVISA, and WHO. Implement and optimize QMS using a risk-based approach, ensuring continuous monitoring and integration of compliance standards. Oversee execution of large-scale validation projects, such as Green Field Injectable facilities, and ensure regulatory approval readiness. Collaborate cross-functionally with Quality, Engineering, Production, and Regulatory Affairs teams for the successful and timely delivery of validation-related initiatives. Promote lean validation practices and continuous improvement strategies to enhance operational efficiency and regulatory compliance. Mentor, develop, and manage a high-performing QA validation team in a cross-cultural, fast-paced environment. Key Requirements : Education : Bachelors or Masters degree in Pharmacy, Chemistry, or related life sciences field. Experience : Minimum 15 years of experience in QA with strong specialization in Qualification & Validation within pharmaceutical manufacturing. Proven experience in injectable/sterile manufacturing environments is highly desirable. Hands-on experience in handling international regulatory audits and validations across FDA, EMA, and ANVISA-regulated markets. Technical Skills : Expertise in Cleaning Validation, PPQ, CSV, QRM, and VMP development. Strong command of GxP and global regulatory guidelines. Proficient in developing and managing QMS with focus on compliance and risk management. Leadership Skills : Demonstrated ability to lead cross-functional teams, influence stakeholders, and manage complex projects under tight timelines. Strong communication, decision-making, and coaching capabilities. Preferred Attributes : Green Field project experience, especially in injectables. Recognized as an SME in QA Validation. Familiarity with modern digital QA tools or systems is an added advantage. Interested candidate can share CV at bhuvneshwari.rathore@amneal.com

Job Description Analysis related to qualification of Instrument/Equipment and Standards Qualification of Standards and Instruments Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Testing of Miscellaneous Material, in-process, finished product and stability samples (as per stability protocol) To ensure the timeline for initiation and completion of testing. To keep update of instruments logbooks and to record the data in LNB during testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department Qualifications Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 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

Job Purpose JOB DESCRIPTION To ensure compliance of computerized systems, PLC/SCADA-controlled equipment, and automation systems with regulatory requirements (21 CFR Part 11, EU Annex 11, GAMP 5, etc.) by executing validation activities as per approved procedures and maintaining validated states throughout the system lifecycle. Key Responsibilities Validation Planning & Execution: Develop and maintain validation protocols (URS, DQ, IQ, OQ, PQ, RTM) for computerized systems and PLC/SCADA-controlled equipment. Execute validation activities in line with cGMP, GAMP 5, and internal SOPs. Review and approve vendor-supplied documentation (FDS, HDS, SDS, FAT/SAT, etc.). Compliance & Documentation Ensure systems comply with 21 CFR Part 11 and data integrity principles. Maintain proper documentation and traceability of all validation activities. Prepare validation summary reports and maintain system validation status. Risk Assessment & Change Management Conduct risk assessments for new or modified systems and automation projects. Participate in impact assessments and manage change control for validated systems. Audit Support & Training Support internal and external audits (USFDA, MHRA, EU, WHO, etc.). Provide training and guidance to users and departments on validated systems and data integrity practices. Coordination & Vendor Management Coordinate with Engineering, IT, QA, QC, Production, and vendors for validation-related activities. Monitor vendor performance and ensure timely completion of qualification activities. Lifecycle Management Ensure systems remain in a validated state through periodic reviews and re-validation as needed. Support decommissioning and archival activities as per SOPs. Key Skills And Competencies Strong knowledge of CSV principles, GAMP 5, 21 CFR Part 11, and Annex 11. Familiarity with PLCs, SCADA, HMI, DCS, MES, and Building Management Systems (BMS). Understanding of pharmaceutical manufacturing processes and regulatory requirements. Good documentation, analytical, and problem-solving skills. Effective communication and project coordination abilities. Qualifications Qualification: B.Pharma/ M.Pharma/ B.E / B.Tech Candidate must have 3 - 5 years of relevant experience. Note: Employee who want to apply for internal job posting must have completed atleast 2 years in his current role. Show more Show less

Job Description JOB DESCRIPTION Analysis and release of RM, PM, IP and FP Knowledge and Skill on Sophisticated instruments like UV, HPLC, GC, UPLC, FTIR, Polarimeter and KF titrator. Knowledge of Chemical analysis. Knowledge of LIMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Knowledge of QMS Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department. Qualifications Education: B.Sc., M.Sc., B.Pharma, Total Experience - 3 - 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

Job Description To operate the necessary equipment such as Vial Filling and sealing, . To ensure compliance with cGMP. To execute manufacturing plan as per given instruction. To manufacture product and operate equipment as per given instruction. To support in timely execution of scheduled activities, equipment installations, qualifications / requalifications as per requirement To work by following GDP and complying to Data reliability principles. Qualifications Education: ITI/ Diploma, Total Experience - 2 - 7 Year in 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

Job Description Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instrument's / equipment's . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instrument's / equipment's. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity. Qualifications Qaulification # B.Sc./M.Sc. Experiance # 1-3 Years Desigantion # As per company Policy 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 Conducting complex Solid Phase Peptide Synthesis (SPPS). Utilizing various resin types such as 2-CTC, Rink Amide, Wang, MBHA, and others Carrying out cleavage, deprotection, and purification processes with high accuracy Applying Fmoc/Boc protection strategies and performing peptide modifications Operating both automated peptide synthesizers and manual reactors. Qualifications Ph. D in Peptide Chemistry 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

Responsible for testing of Raw material,IP/ FP and Stability sample as per method of analysis. Should have knowledge for the Method Verification/validation and Method Transfer analysis. Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments . Should have exposure on sophisticated Instruments i.e. HPLC, Dissolution,FTIR,UV, GC, Autotitrator,Karl fischer,PSD etc. Have an exposure for the preparation of calibration & PM schedule of laboratory instruments / equipments. Should have knowledge for the preparation, handling & management of working/reference standards etc. Testing of In-process, Stability and Finished product samples,Raw material. Should have awareness of Caliber LIMS system operation. Having exposure of Method transfer/verification /validation activity.

Job Responsibilities JOB DESCRIPTION To handle and distribute various samples received for microbiological analysis. To maintain the logbook for the same. Maintain housekeeping of Microbiology lab. To maintain the inventory of various microbiological media, maintain log and status labels, media preparation, growth promotion test and reconciliation of media. Microbial culture handling and inoculum preparation. Water sampling and analysis of water samples as per schedule, with completion of all reports and records. Responsible for Sterility testing, Bacterial endotoxin testing, antibiotic microbial assay and bio burden testing of Raw material, in-process, finished products. Environmental monitoring of microbiology lab clean room area as per the defined schedule. Non-viable particle monitoring of microbiology lab clean room area as per the defined schedule. Responsible to identify and maintain data logging of EM Isolates. To perform disinfectant efficacy testing as per SOP. To perform microbial identification as per defined schedule. Responsible for handling and testing of biological indicator. To perform CCIT test of post media fill units. To perform observation of microbial plates exposed in manufacturing area. To perform media fill unit observation as per SOP. Responsible for reporting any OOS, Deviation to In-charge. Responsible for preparation of standard operating procedures of microbiology department. Responsible to co-ordinate with manufacturing, Engineering, and other QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities. Responsible to participate in perform qualification activities of manufacturing and Microbiology area. Responsible for Compressed air /nitrogen gas monitoring and Personnel monitoring. Preparation of indents as per the materials/product requirements. To initiate and review of a) Change controls b) Out of specifications c) Deviations. To attain and complete self- training record. Preparation of study protocols with respect to laboratory. Review of instruments logbooks, raw data of raw materials, packing materials, miscellaneous materials, in-process, finished products and water analysis. Preparation of COA. To keep neat and cleanliness at workplace and follow the good laboratory practices and safety related instruction in the laboratory. To perform water analysis and maintain daily water trend. Sampling, testing and release of Raw material, packing material, miscellaneous material samples and in process sample and maintain reserve sample as per SOP. Qualifications Qualification: M.Sc (Microbiology) / B.Pharm Experience: 4-7 years Show more Show less

Job Responsibility JOB DESCRIPTION 1 Responsible for preparation of packaging planning on monthly and also daily as per the requirement and availability of materials. 2 Responsible to update on self-hygiene. 3 Responsible to attend the training as per training schedule and to ensure the training as per TNI. 4 Responsible to work as per standard operating procedures, in general area of sterile manufacturing department. 5 Responsible for preparation, review, revision, control and implementation of Standard Operating Procedures of General Area in Sterile Manufacturing Department. 6 Responsible for BPR Preparation. 7 Responsible to ensure that all equipments and lines are in validated and calibrated status. 8 Responsible to check that all the records and log books related to general area and equipment of packaging, inspection area. 9 Responsible to give training to all the subordinates, technicians and operators of the department. 10 To follow the cGMP, Good Document Practice and discipline in the department. 11 Responsible for document handling of Packing, and Inspection. 12 Responsible for monitoring of all the activities related to packing, and inspection. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 2 - 7 Year in sterile manufacturing plant Show more Show less

Key Responsibilities JOB DESCRIPTION Material Receipt & Verification — Oversee material receipt, verification, labelling, and GRN preparation in ERP. Storage & Inventory Management — Ensure proper storage, stock updates, and scheduled physical verification. Material Issuance & Dispensing— Manage material dispensing as per BMR/BPR and maintain accurate stock records. Storage and Dispatch of Finished Goods— Coordinate with departments for smooth Dispatch and handling of Finished goods. Compliance & Documentation — Maintain warehouse records, review QMS documents, and ensure SOP adherence. Coordination & ERP Monitoring — Coordinate with departments for smooth operations and oversee ERP functions. Qualifications Qualification: M.Sc / B.Pharm / M.A / M.Com Experience: 4-6 years Show more Show less

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