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.

Job Description Job Responsibility Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labeling and packing. Responsible for review of executed BMRs and BPRs for batch release. Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP. 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 planner and calibration certificates. Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc. Responsible to monitor cGMP compliance at shop floor. 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. 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. To perform aseptic behavior/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 2 - 7 Year in IPQA Department of sterile manufacturing plant Show more Show less

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 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 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

Description JOB 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. Qualifications 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. Show more Show less

Job Description 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. Qualifications 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. Show more Show less

Job Description 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.. Qualifications Qualification - B.E Chemical / B. Tech Chemical Show more Show less

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

Perform and review method validation of Assay, Dissolution, Related compound and Residual solvents etc. for new projects using instruments like HPLC, IC and GC etc. Preparation of method validation/verification protocol (API and finish product) like HPLC, GC, IC, and ICP-MS etc. Check and perform the method transfer protocol/report and methods and resolve the query of Assay, Dissolution, Related compound and Residual solvents etc. To coordination with ARD-Development, QA and QC Ensure timely completion of validation/verification and method transfer as per timeline To be able to perform the Daily calibration all instruments/equipments as per respective schedule. To be able to perform the periodic calibration, Maintenance of all instruments/equipments as per respective schedule. To be able to perform the daily temperature monitoring of Freeze and Freezer To be able to maintain and review the qualifications, preventive maintenance and calibration of instruments/equipment s and their records To be able to review stability chambers data and print outs.

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:

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

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.

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.

Understanding of product development related activities of all injectable dosage forms for regulated market. Exposure to injectable dosage form which includes exposure in development of complex injectable products like suspension-based formulation, liposomal formulations, Polymer based products etc. Experienced in preparation and review of product development report, MFR, stability protocol and other study protocols and SOP etc. Basic understanding of implementation of QbD principles for formulation and development (QTPP/CQA/CPP/CMA, risk assessment and control strategy etc.) Effective co-ordination with different departments like regulatory affairs, manufacturing warehouse, quality assurance, quality control and engineering etc. for execution of scale up and exhibit batches.

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 CAPAs. 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 HODs instruction and guidance.

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 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

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, 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 portal 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.

Key Responsibilities: Water sampling and analysis Microbial Limit Test Sterility test Bioburden test Preservative efficacy test Bacterial endotoxin test.

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

The role involves handling the following responsibilities: Monitoring of Wet Analysis Specification Preparation CCF Handling Instrumentation: HPLC and GC Analysis

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