Job Description Attend and ensure the training as per training schedule and TNI Work according to standard operating procedures in sterile manufacturing department Prepare, review, revise and control the Standard Operating Procedures of General Area in Sterile Manufacturing Department Prepare BPR Validate and calibrate all equipment and lines Record and check all the logbooks related to general area and equipment of packaging and inspection area Train all the subordinates, technicians and operators of the department Comply with cGMP, Good Document Practice and departmental discipline Handle document of Packing and Inspection Monitor all the activities related to packing and inspection Qualifications M.Sc. / B. Pharm / M.Pharm

Job Description Responsible to follow the preventive maintenance schedule of machine. Responsible to check UAF working in area. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in area. Responsible to fill the logs, BMRs and documents of area as per SOP and work execution. Responsible to operate the machines and vessels of area as per SOP. Responsible for cleaning and sanitization of area as per SOP. Responsible for line clearance activity before commencing the operations as per SOP. Responsible for Manufacturing, Filling, Packing and Visual Inspection. Qualifications ITI / B.Sc / Diploma

JOB RESPONSIBILITY: To ensure safety equipments (Fire Hydrant system, Fire alarm system, Fire extinguishers etc are working & active condition To ensure safe handling of Hazardous chemical, hazardous waste, biomedical waste and its disposal as per guideline Participation in Fire Drill, Mock drill, safety committee and its compliance To ensure implementation of all EHS policy and SOP and its compliance. To ensure monthly environment monitoring by third party Conduct EHS related Training as per training Calander To fill and update all relevant formats as per defined frequency. Response quickly while in firefighting, rescue, and other related emergency services. To report unsafe condition and unsafe practices inside the plant & its compliance. Supervision of ETP operation and its compliance Actively participation during safety week, environment day celebration. Working in shift for compliance of all EHS related SOP, Policy Educational Qualification: Diploma Industrial safety or post diploma industrial safety Experience Required: 1 to 3 years of relevant experience

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. To perform the Qualifcation/Process validation/Cleaning validation /Utility Validation. Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HOD'S instructions and guidance. Qualifications for Internal Candidates should completed the B.Pharm or M.Pharm with minimum 1 year experience. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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 HOD'S instructions and guidance. Qualifications for Internal Candidates should completed the B.Pharm or M.Pharm or M.sc with minimum 1 year experience. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Responsible for Visual inspection & Packing Responsible to operate the machines Responsible for cleaning and sanitization of visual inspection and Packing area. Responsible to all packing related activities. Responsible to fill the log of general area as per SOP and work execution. Responsible to attend the training as per schedule and to ensure the training as per TNI. Responsible to follow the preventive maintenance schedule of machine. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in visual inspection and Packing area. To follow the cGMP, Good Document Practice, and discipline in the department. Responsible for line clearance activity before commencing the operations. Education: ITI/ HSC / Diploma/ Graduation

Job Description: Digital Transformation Lead digital and automation projects to enhance cost, productivity, and quality in manufacturing. Oversee project management from design to Go Live and ensure scalability and sustainability. Develop requirement documents and ROI calculations. Validation & Compliance Perform system validations ensuring compliance with cGMP, FDA, and GAMP standards. Maintain audit-ready documentation and adherence to the Validation Master Plan. Integration & Automation Collaborate with Engineering and IT for seamless system integrations (PLC, SCADA, IoT, LIMS, MES, ERP). Manage advanced manufacturing technology projects. Advanced Analytics Drive predictive analytics and real-time data projects to improve operational efficiency. Support energy-efficient and sustainable automation initiatives. Cybersecurity & Data Integrity Ensure compliance with cybersecurity policies and protect systems from threats. Collaborate with IT for security assessments and maintain data integrity. Cross-functional Collaboration Work with stakeholders across QA, IT, Operations, EHS, and Engineering to ensure project success. Provide training and support to teams on digital systems and automation. Continuous Improvement Stay updated on digital trends and Industry 4.0 solutions. Evaluate and recommend digital innovations to maintain a competitive edge. Team Capability Building Train staff on automation and digital systems, developing materials and conducting workshops. Education: BTech. B.Tech/BE (Preferred Stream - Computer Science, Electronics, Electronics & Communication, Instrumentation & Control Engineering, Information Technology) Electrical and Electronics will be preferred. Total Experience - 0-1 Year in sterile manufacturing plant

Responsible to follow the preventive maintenance schedule of machine. Responsible to check UAF working in area. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in area. Responsible to fill the logs, BMRs and documents of area as per SOP and work execution. Responsible to operate the machines and vessels of area as per SOP. Responsible for cleaning and sanitization of area as per SOP. Responsible for line clearance activity before commencing the operations as per SOP. Education: ITI/ Diploma

Monitor and ensure adherence to enterprise data management procedures and standards. Enter / update master and reference data for assigned data domains (Products, Customers, Vendors, Accounts, Items) in multiple systems. Maintain business data glossaries, taxonomies, and catalogs. Support onboarding/ offboarding of new Master Data datasets and associated data attributes. Support data quality issue resolution by triaging master data issues generated by the enterprise Data Quality engine. Conduct root cause analysis of master data accuracy, completeness, timeliness, consistency, uniqueness, integrity issues, and propose solution to solve problem at root cause. Review critical data exceptions generated by various systems and work with appropriate stakeholders to coordinate resolution. Work with Data Owners to resolve issues, either by changing the data at the source system, or update the data in the Master Data Management system, or updating crossfunctional / crossregional / crossdepartmental reference data mappings. Competencies: Ability to learn new technologies quickly. Excellent business acumen and communication skills. Ability to think outside the box and a strong curiosity to understand and learn new things. Demonstrated understanding of business data, proper data use / consumption, data quality, and stewardship. Ability to partner with both business and technical subject matter experts to ensure standardization of operational information and execution of enterprisewide data governance policies and procedures. Ability to solicit followership from the functional teams to think beyond the ‘way the things work today’. Ability to align various stakeholders to a common set of standards and promote the benefits of master data quality and governance. Dealing with ambiguity, Leading change, Making a measurable positive impact. Qualification- Bachelor’s degree in a technical field Experience- 5-12 Yrs. 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 Responsible to operate the machines Responsible for cleaning and sanitization of visual inspection and Packing area. Responsible to all packing related activities. Responsible to fill the log of general area as per SOP and work execution. Responsible to attend the training as per schedule and to ensure the training as per TNI. Responsible to follow the preventive maintenance schedule of machine. Inform immediately to concern supervisor for any observation/disturbance with respect to documents and machines found in visual inspection and Packing area. To follow the cGMP, Good Document Practice, and discipline in the department. Responsible for line clearance activity before commencing the operations. Qualifications Education: ITI/ Diploma/ Graduation Total Experience - 1 to 5 Year in Manufacturing/packing department of sterile manufacturing plant

Hiring for ARD Inhalation department for SEZ Matoda, Ahmedabad location Designation : Executive/Sr.Executive/ Assistant Manager Qualification : M.sc, M.Pharm Experience : 6 to 9 years Please find below job description : Method Development, Stability, Method Validation & routine analytical activities for MDI DPI. Operation and troubleshooting of MDI/ DPI instrument like NGI, ADSA, PSD, DUSA etc. for day-to-day analysis. Hands on experience of HPLC, GC, GCMS, LCMS, Karl Fischer Titrator etc. Preparation and review of Standard test procedure, approval of specifications,analytical methods, SOPs and change control. Literature search and DMF review. Co-ordinate with inter & intra department contact for related issues. Knowledge on Stability evaluation, Tech Transfer and query work. Interested candidate can share cv on with caption " CV for ARD Inhalation" on chandanid@amneal.com

Job Responsibility JOB DESCRIPTION 1 Responsible for preparation of Production & 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 batch Manufacturing, 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 batch Manufacturing, Packing, and Inspection. 12 Responsible for monitoring of all the activities related to batch Manufacturing, packing, and inspection. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 2 - 7 Year in sterile manufacturing plant

Job Description Review of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment.Review of Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions.Performing investigation of Unplanned deviations, Out of specification, Out of Alert Limit, Computer system incident, Environmental Excursions.Tracking and closure of Change controls, CAPAs, Unplanned Deviations, Planned Deviations, Risk Assessment, Out of Specification, Out of Alert limit, Computer system incident, Environmental Excursions within allotted target date.Review and closure of effectiveness check of actions.Performing assessment of received other site CAPA and tracking closure.Evaluate CAPA and notifying to other sites.Preparation and review of SOPs.Preparation of presentation for QRB, Quarterly meeting.To perform the allotted task by HOD other than defined in Job Description. Qualifications Education: B.Pharma, M.Pharma

Job Description Proactively assess quality issues and ensure compliance to QA/QC as per regulatory requirements in manufacturing operations and quality function at site by keeping track of quality metrics.Ensure all time readiness of site for regulatory/statutory inspections/ internal audits and Regularly monitor performance of each individual in Quality department.Facilitate internal and regulatory agency audits, and ensure findings from site audits are understood, assessed and addressed in a comprehensive manner . Ensure closure of audit observations by reviewing the CAPA and driving its implementation.Ensure implementation of requisite changes at the plant level as per global/local regulations. To escalate any Batch failure, Quality complaint, recall, critical observation etc. to senior management.Provide leadership and direction to ensure achievement of accountabilities for all Quality sub functions at site.Ensure timely updation and approval of all master documents i.e. BMR, SOPs, Specifications, site master file, validation master plan, schedules etc.To ensure that validation system remain updated as per regulatory requirements and industry standards. 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 of Standard Operating Procedures of Quality Assurance Department Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.Responsible for review of media fill BMR.To ensure timely release of manufactured batches by reviewing BMR/ BPR and their compliance.To ensure In- process testing & release timely.Training and post training evaluation of staff and worker: Identifying training needs, scheduling and conducting training program, training and qualification of trainer, certification and evaluation. 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 for review and approval of documents like Validation protocols, reports, QRM, SOPs etc.Responsible for the assessment, review and Approval of Change Control, Deviation, CAPA, Investigation etc.Responsible for approval of URS, DQ and vendor/ suppliers documents related to qualification.Annual Product Quality Review (APQR/APR) Review: Review & trending of quality parameter to quality performance consistency.Handling of Market Complaint: Complaint Investigation, root cause analysis, Impact assessment and risk assessment of received market complaint, FAR and Quality Defect reporting to Regulatory agency, trending of complaint and excellence study of complaint nature.Recall and Product Failure Investigation: Product failure investigation, Periodic inspection of retained, controlled and stability sample, handle the mock recall and product recall.To be part of investigation team & to perform the investigation of non-conformance (i.e. deviation, market complaint, OOS, OOT etc.).Trend analysis of deviations to evaluate recurring problem and to recommend the CAPA if required. Self-inspection of the different departments. Preparation and review of self-inspection report.To review the compliance/action plan against the noted observations noted during self-inspection.Co-ordination and participation in Quality management review.Approval of Master Documents like specification, Method of Analysis, Stability Study report, SOP etc.Vendor Qualification: Handling the Vendor Qualification and Re-approval audit for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary Packaging Material), Contract analysis laboratory and Contract services. Qualifications Education: B.Pharma, M.Sc., M.Pharma, Total Experience - 12 - 16 Year in sterile manufacturing plant. Note: Candidates who want to apply for internal jobs, must have completed at least 2 years within existing role.

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

Job Description To ensure the compliance as per Quality management systemResponsible for calibration of all equipment’s. Responsible to review calibration certificatesResponsible to coordinates with user for calibration clearanceResponsible to prepare SOPs, and QMS documentation.Responsible for fix and verify calibration tag on the machine.Responsible to review ,prepare and update the relevant calibration documents.Responsible for maintaining calibration related records.Responsible to assist engineer in installation & commissioning of plant machinery.Responsible to attend critical breakdown.Responsible for preventive maintenance of equipment’s.Responsible to carry out all work as per cGMP and GEP.To ensure GDP in engineering documentsTo ensure the execution of activity as per regulatory standards Responsible for issuance and control of all cGMP documents of engineering department Qualifications Education: Diploma / B.E. Total Experience - 2 - 7 Year in Engineering department of sterile manufacturing plant

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

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

Company Description Amneal (NASDAQ: AMRX) is a purpose-driven pharmaceutical company focused on delivering more affordable access to essential medicines. With a robust U.S. generics business, a growing branded business, and portfolios in injectables, biosimilars, and select international markets, Amneal is dedicated to making healthy possible for all. The company invests in its people through leadership development and employee well-being programs to deliver even more value to the community. Role Description This is a full-time on-site role located in Ahmedabad for an Operator/Officer/Sr. Officer/Executive/Sr. Executive at Amneal Pharmaceuticals. The role involves day-to-day tasks related to pharmaceutical operations and ensuring the efficient production of essential medicines. Qualifications Experience in pharmaceutical operations and manufacturingKnowledge of GMP guidelines and quality standardsStrong attention to detail and analytical skillsAbility to work in a fast-paced environmentExcellent communication and teamwork skillsBachelor's degree in Pharmacy, Chemistry, or related fieldExperience in a pharmaceutical manufacturing setting is a plus

Job Description Automation and Equipment Upgradation:Co-ordinate for all existing automation projects including L2 Integration, DCS, and SCADA across various sites and ensure project success as per defined business proposals.Identify opportunities for automation and equipment upgradation to improve manufacturing processes and efficiency.Design, develop, and implement automation solutions for various equipment and processes across manufacturing and packing operations.Research and identify new automation technologies to enhance productivity, efficiency, and quality within manufacturing and packing operations.Evaluate and recommend upgrades or replacements for outdated equipment to ensure continuous improvement and innovation.Collaborate with cross-functional teams to ensure seamless integration of new and existing equipment and automation systems.Provide training and support to operations teams on new equipment and automation systems.Share knowledge and best practices with other teams to promote a culture of continuous improvement.Partner with each site team for the execution of the Automation/Upgradation projects.Continuously assess and identify needs for further automation to maintain cutting-edge manufacturing capabilities. Compliance and Regulatory:Ensure all automation and equipment upgradation projects comply with regulatory requirements, such as USFDA, EU GMP, and ISO with site coordination.Identify recent 483s related to Manufacturing Equipment, Systems, and processes, and plan the compliance of operations accordingly.Identify recent trends in regulatory expectations related to automation/alarms/audit trail/user management and perform gap analysis for operations.Collaborate with Production, Packing, QA, Engineering, and Regulatory teams to ensure compliance with company policies and procedures.Regularly review and update compliance protocols in line with new regulatory guidelines and expectations. Project Management:Manage multiple projects simultaneously, prioritizing tasks and resources to meet project deadlines and budgets.Develop and execute project plans, including timelines, resource allocation, and budgeting.Coordinate with vendors, contractors, and internal/external stakeholders to ensure successful project execution.Regularly communicate project status and needs to stakeholders to ensure alignment and support. Qualifications Education:Bachelor's/Master's degree in Science/Pharmacy/Engineering or related field. Experience:Minimum 5 years of experience in manufacturing/engineering with expertise in projects/equipment qualification/validation.Experience with automation systems, such as PLCs, SCADA, and MES.Familiarity with regulatory requirements, such as FDA, EU GMP, and ISO 13485. Skills:Strong knowledge of automation technologies, including sensors, PLCs, and SCADA.Experience with equipment design, installation, and qualification.Excellent project management skills, with the ability to prioritize tasks and manage multiple projects.Strong communication and interpersonal skills, with the ability to collaborate with cross-functional teams. 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.