About Us Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws. Show more Show less

Experience: 2 to 5 years Job Description: Ensure adherence to cGMP and safety norms during manufacturing operations Execute batch processes and maintain proper documentation in BMR/BCR/Logbooks Maintain good housekeeping practices Strong communication skills are essential Candidates must have completed at least one year in their current role M.Sc. or B.Sc. in Chemistry

Adherence to cGMP and safety norms during manufacturing operations Execution of batch processes and proper documentation in BMR/BCR/Logbooks Maintain good housekeeping practices Strong communication skills are essential Qualification: M.Sc. or B.Sc. in Chemistry

Responsible for preparation, review, revision, control, and implementation of standard operating procedures of packing department. Responsible for preparation & review of the master documents of packing. Responsible for preparation and review of Protocols and reports based on the requirements. To assist the officers and Executives for document management and preparation like BPRs master SOPs etc.. Responsible to identify training needs and impart training of SOPs and developmental training within the department and for another department. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. To assist the packing officer for line clearance activity before commencing the operations like labelling and packing operation. To have good communication skill to avoid misunderstanding. Arrange to send requisition in advance to the store get the material required for the next day production plan. Responsible to monitoring of all the activities related to packing. Responsible to give proper planning to subordinates and ensure its implementation. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to helpful all the types of validation, calibration, and verification. Responsible to check all the record and logbooks related to packing area. Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to keep area updated with all the document and cleaning. Responsible to provide guidance to subordinates. Responsible to be fully familiar with machine and activities in his work. Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 3 - 7 Year in sterile manufacturing- packing

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

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc. Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment’s usage logs and Deviation reports if, any. To co-ordinate with engineering department for the shift break down jobs. To monitor the utility operation in the plant and report any abnormality to engineering department. Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production. Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure. To maintain good housekeeping in respective manufacturing area during process. Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures. Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products. To monitor the process online and record/fill the entire document legible. Continuously monitor & maintain process parameters as per the desired product specifications and quality. To record and maintain all the documents online as per CGMP. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III). To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing and safety point of view. Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents. Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures. Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition. Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality. Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials. Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc.. Qualification - B.E Chemical / B. Tech Chemical

Responsible to assist installation & commissioning of plant machinery. Responsible for qualification & documents related to qualification of plant machinery. Responsible for executing and installation of plant equipment’s and monitor the site execution work in project. Responsible for maintenance and breakdown activity related to plant equipment / machineries. Responsible to procure & maintain the critical spares inventory. Responsible to update and maintain all cGMP documents related to breakdown & preventive maintenance of plant machinery as per SOP. Responsible to supervise the calibration activity and maintain the related documents. Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance. Responsible to carry out all work as per cGMP and GEP. Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP. Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc.. Responsible for co-ordination with vendors and purchase department Responsible for qualification & documents related to qualification of plant machinery. To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner. Preparation and review of QMS documentation. Education: Diploma/ B.E. Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant

Job Description Responsible for preparation, review, revision, control, and implementation of standard operating procedures of packing department. Responsible for preparation & review of the master documents of packing. Responsible for preparation and review of Protocols and reports based on the requirements. To assist the officers and Executives for document management and preparation like BPRs master SOPs etc.. Responsible to identify training needs and impart training of SOPs and developmental training within the department and for another department. Responsible for the handling of Change Control, Deviations, CAPA, Investigation etc.. To assist the packing officer for line clearance activity before commencing the operations like labelling and packing operation. To have good communication skill to avoid misunderstanding. Arrange to send requisition in advance to the store get the material required for the next day production plan. Responsible to monitoring of all the activities related to packing. Responsible to give proper planning to subordinates and ensure its implementation. Responsible for preparation of production planning on monthly and daily as per the requirement and availability of materials. Responsible to prepare daily production report as per the production achieved. Responsible to helpful all the types of validation, calibration, and verification. Responsible to check all the record and logbooks related to packing area. Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to keep area updated with all the document and cleaning. Responsible to provide guidance to subordinates. Responsible to be fully familiar with machine and activities in his work. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 3 - 7 Year in sterile manufacturing- packing Show more Show less

Job Description JOB DESCRIPTION Product evaluation, identification, therapy area and competition mapping Prepare business cases models with customization of strengths, In-house, In-licensing, partnership with agreed terms and conditions of the business opportunities Product Valuations of current and potential new opportunities with discounting techniques i.e., DCF, NPV, IRR, PBP, ROI etc. Financial Modeling to check all possible financial viability of the project (Revenue, Sales, COGS, EBITDA, CAPEX, Gross Margin etc.) Build detailed Business cases, strategy document for all selected products Generate competitive intelligence data for peers, partners, products, and market Supporting team in analyzing the various new business opportunities. Building ROI for Investment required for facility and product acquisition OR CAPEX justifications Preparation and compilation of power point presentations and Ad-hoc reports Automation on reports and templates including large volume IQVIA data Update of Master Portfolio and supporting in data requirements Market research of products to identify and track competition, Sales, and Volume and to check the lucrativeness of the products Improvise and support team in presentation of various data requirements to the stakeholders Escalate issues that weaken portfolio and project success Qualifications Required skills and qualifications B Pharma and qualification of MBA in Finance would be preferred Overall experience of 5 to 7 years and Preferably 3 + years of functional experience in generic Portfolio Management Exhibit strong knowledge of the Pharmaceutical domain with a comprehensive understanding of the US & EU Pharma market Must understand pharmaceutical business process such as Product Development, Dossier Filing and Pharma Market Good understanding and hands-on experience of using various analytical tools and databases Good presentation skills and ability to independently conduct secondary research Good communication, networking, and interpersonal skills to connect with internal and external stakeholders Ambitious and Self-driven Advanced expertise in MS Excel, MS Word, MS PowerPoint 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

Job Description Responsible to assist installation & commissioning of plant machinery. Responsible for qualification & documents related to qualification of plant machinery. Responsible for executing and installation of plant equipment’s and monitor the site execution work in project. Responsible for maintenance and breakdown activity related to plant equipment / machineries. Responsible to procure & maintain the critical spares inventory. Responsible to update and maintain all cGMP documents related to breakdown & preventive maintenance of plant machinery as per SOP. Responsible to supervise the calibration activity and maintain the related documents. Responsible to generate tools and parts requirement for daily breakdown and preventive maintenance. Responsible to carry out all work as per cGMP and GEP. Responsible to update and maintain all cGMP documents related to breakdown and preventive maintenance as per SOP. Responsible for handling quality management documents i.e., Change control, Deviation, CAPA, Quality Risk Management etc.. Responsible for co-ordination with vendors and purchase department Responsible for qualification & documents related to qualification of plant machinery. To ensure that Preventive and Predictive Maintenance is carried out in co-ordination with the concerned departments as per planner. Preparation and review of QMS documentation. Qualifications Education: Diploma/ B.E. Total Experience - 3 - 7 Years of experience in engineering plant maintenance role for sterile manufacturing plant Show more Show less

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

Job Description To follow safety rules in the premises according to the company norms. To maintain the BMRs and other log books in the aseptic processing area as per cGMP and SOP. Preparation and periodic revision of SOPs related to aseptic processing area. Monitoring of DP, RH and temperature in aseptic processing area. Responsible to perform the in process checks during filling. To ensure aseptic area cleaning and fogging to coordinating with engineering department as per the schedule. Operation and Cleaning of heating cooling skid, CIP & SIP skid. Responsible for environmental monitoring of (Viable) aseptic processing area. Timely completion of SOPs training and on the job trainings related to aseptic processing area. To ensure all equipments cleaning activity like CIP / SIP for vessels before starting of the batch process and after completion of the batch process related to filling and filtration. To ensure all aseptic processing area equipment's change parts cleaning and storage as per the procedure. Responsible for cleaning verification and preparation of filling parts for autoclaving Responsible for operation and cleaning of area equipment present in the filling area like filling machine, Rubber stoppering, sealing machines, Isolators, Pass boxes, Glove cleaning and integrity testers including VHP. Responsible to carry out the filling, stoppering, lyophilization and sealing operations as per the SOP and BMR. Responsible for the co-ordination with cross functional departments like QA, QC, warehouse Engineering, HR and administration for day to day activities. Responsible for timely completion of calibrations and validations in coordination with engineering and QA related to aseptic processing area. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance. Qualifications Qualification - B. Pharma, M.Pharma, B Tech, Diploma 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

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 KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department 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.

The role involves handling the following responsibilities: • Monitoring of Wet Analysis • Specification Preparation • CCF Handling • Instrumentation: HPLC and GC Analysis Qualification: M.Sc. Chemistry / B. Pharmacy / M. Pharmacy

Job Description: Planning and monitoring of in-process, finished, intermediate, and raw material analysis Handling Quality Management System (QMS) activities, including OOS (Out of Specification), OOT (Out of Trend), Change Control, and CAPA (Corrective and Preventive Action) management Oversight of laboratory support activities such as instrument calibration, impurity profiling, and standard qualifications Leading second-level Quality Control (QC) activities Hands-on experience with both internal and external audits MSc Chemistry / B Pharmacy / M Pharmacy

Major accountabilities The primary goal of the Key Account Manager would be to manage the overall relationship of the top key account and ensure value selling. Drive and grow business within identified key accounts – understand competitors' volume of business within those accounts, anticipate barriers to product usage and ensure access to targets. Responsible to drive new conversions and performance of big corporate account and develop sales pipeline and conversion plan as projected. Review key account sales performance on a regular basis and take corrective action. Accountable for achieving the yearly budgeted target - Build a forecast state wise to meet the budget numbers. Responsible to manage the Internal & External Relationship - Identify key stakeholders and build & manage relationships within identified Key Accounts. Builds extensive relationships with decision makers and influencers of key accounts after assessing their needs, purchasing method, and frequency of contact preferences strictly adhere to the compliance guidelines while engaging with KOLs or other commercial entities. Drive execution excellence Responsible for engagement and development of KOL/KBL customers Achieve Monthly, Quarterly & Annual Sales Targets of segment as per the given territory. Driving business development initiatives to expand business through new hospital entries. Responsible for Customer Satisfaction - Solicit Customer Satisfaction Surveys participation, investigate causes of customer dissatisfaction. Update the Must-See List (MSL) regularly by identifying the uncovered doctors on CRM. Promote Amneal Differentials for creating brand recall amongst the doctors. Map Efforts with Outcomes and drive effectiveness and efficiency. Design and deploy KPIs to capture success of Account. Support commercial excellence team with channel performance dashboards for management review. Channel performance reporting and execution analytics. Bachelor’s Degree in science or equivalent level of educational background/ MBA preferred 6-9 plus years of successful hospital sales business

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 KFtitrator. Knowledge of Chemical analysis. Knowledge of LIMS/QMS Knowledge of current pharmaceuticals guidelines (eg. ICH, cGMP etc.) Troubleshooting and decision skills for analytical problems. Responsible to perform activities with respective TNI . To ensure the timeline for initiation and completion of testing. Responsible to maintain quality standards that apply to product Analysis, ensuring proper implementation. To maintain the cleaning in quality control department 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.

Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing. Responsible to perform the environment monitoring activities Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. Responsible for review of executed BMRs and BPRs. Responsible to perform the in-process test at different stages as per batch document/SOP. Responsible to review the environment monitoring, water trends. Responsible to review the different type of planner and calibration certificates. Responsible to receive the required resources for EM monitoring e.g., plates, samplers, swabs etc.. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc.. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area. Responsible to monitor cGMP compliance at shop floor. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.. To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g., plates, swabs, etc.. Environmental monitoring of manufacturing clean room area as per the defined schedule. Responsible to participate in media fill simulation study. Responsible to participate in perform qualification activities of manufacturing area. Non-viable particle monitoring of manufacturing clean room area as per the defined schedule. Compressed air /nitrogen gas monitoring and Personnel monitoring. Review of Media fill CD. Review of Visual inspector qualification record. Education: B.Sc./ M.Sc in Microbiology Total Experience - 2 - 4 Year inexperience in Environmental Monitoring for sterile manufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 years within existing role.

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

Description: To ensure compliance with cGLP regulations by analysis and calibration of all aspects of Quality Control at the manufacturing site Essential Functions: To be responsible for Analysis and Calibrations of Quality Control Laboratory instruments. To be responsible for Receipt, verification, storage and issuance of laboratory chemicals and glassware. To be responsible for Preparations of volumetric solutions, test solutions, limit test solutions and indicator solutions. To be responsible for Maintaining of Good Laboratory Practices in lab. To be responsible for Checking regular cleanliness of laboratory. To be responsible for Management of all types of Standards. To be responsible for Receiving and maintenance of Chromatographic columns. To be responsible for Cleaning of Instruments. To be responsible for Receiving samples and In-warding them in the respective registers/LIMS. To be responsible for Preparation and execution of Protocols. To be responsible for Maintain the contact with vendor. To be responsible for Daily temperature monitoring of QC laboratory Additional Responsibilities: To be responsible for Investigation related to LIR, deviations, OOS and OOT. To be responsible for Initiation of Deviations, OOS, OOAL, CRN and CAPA's. To be responsible for Handling of Caliber e-LIMS Activities other than defined in the Job responsibility are to be done as per the requirement of HOD, by following HOD's instruction and guidance. Education: B.Sc., M.Sc., B.Pharma, M.Pharma, Total Experience - 3 - 7 Year in QC department of sterilemanufacturing plant Note: Candidates who want to apply for internal jobs, must have completed atleast 2 yearswithin existing role.