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

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 to ensure the cleaning and sanitization of machines, instruments and equipment’s and area. Responsible for line clearance activity before commencing the operations as per SOP. Responsible to operate the machines, instruments, and equipment’s of area. Inform immediately to concern supervisor for any observation/disturbance found in the aseptic area. Responsible to update on self-hygiene, cleaning & sanitization of area, follow SOPs, filled the document, of area. Responsible to fill the log of area as per SOP and work execution. Responsible to ensure UAF working in area. To follow the cGMP, Good Document Practice, and discipline in the department. Responsible to perform all the activities related to general and controlled area. Responsible to follow the preventive maintenance schedule of machine. Qualifications ITI / Diploma / B.Sc Show more Show less

Job Description Key Responsibilities : 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 Short Description for Internal Candidates Education: ITI/ Diploma/ Graduation Total Experience: 2 to 7 Years in Manufacturing/packing department of sterile manufacturing Show more Show less

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

Key Responsibilities 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. Responsible 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. 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. 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 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 keep area updated with all the document and cleaning. Qualifications Education: ITI/ Diploma/ Graduation Total Experience: 2 to 7 Years in packing department of sterile manufacturing Show more Show less

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 B. Sc / M. Sc / B. Pharm / M. Pharm Show more Show less

Job Description JOB DESCRIPTION FOR SETE ENGINEERING LEAD Regular co-ordination with US CFTs and to plan, navigate and delegate work distribution amongst team members. To train, monitor, build and align the team for procedure, system and timely support of services to US CFTs. To review and co-ordinate written documentation for all manufacturing activities. These documents include but are not limited to master batch records, SOPs, Change controls and other manufacturing related documentation etc. To review and co-ordinate Process/Cleaning validation/study assignments and projects which require sound pharmaceutical/engineering skills. To review and co-ordinate validation document activities such as FAT, IQ, OQ, PQ, Re qualification protocol, Revision in qualification documents, other documents for equipment/utilities/facilities for US sites. Also support extension for rest sites in world. Prepare regular reports on performance, progress, and issues for senior management and US CFT. Preparation of departmental budget and monitoring. Guide, motivate, and supervise team members to achieve individual and organizational goals. Set goals, develop plans to achieve them, and align team activities with overall company strategy. Monitor and evaluate employee performance, provide feedback, and implement improvement plans when needed. Identify issues, analyse them, and implement solutions effectively and efficiently. Serve as a bridge between upper management and staff, ensuring information flows smoothly in both directions. Identify training needs, help with career development, and foster a learning culture. Ensure the team follows company policies, legal requirements, and safety guidelines. Participate in recruiting, interviewing, and selecting new team members to build a strong workforce. Assign tasks to the right team members based on their skills and workload, ensuring efficient execution. Communicate with clients, vendors, or internal stakeholders to manage expectations and maintain strong relationships. Create a positive work environment by recognizing achievements, encouraging collaboration, and promoting morale. Show more Show less

Job Description Core analytical method development and CMC activities for Inhalation dosage forms. To perform analytical activities of development, scale up support, method validation, method transfer, release, stability, drug product characterization, E&L Study, In-vitro study, routine analysis of inhalation dosage forms. To perform tests like assay, related compound, APSD, DDU and particulate matter etc. for inhalation dosage form. Qualifications M. Pharm / M. Sc. / B. Pharm 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 Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment’s. To attend the breakdown maintenance of all Electrical power distribution equipment’s like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supervisor for statutory requirements. To perform all the jobs with safety rules and regulation and as per cGMP. Responsible to operate the utility equipment’s efficiently. Responsible to maintain the critical spares inventory for utility equipment. Responsible to provide necessary utility to production department or another user. Responsible to update and maintain all utility equipment records per SOP. Responsible to carry out all work as per cGMP and GEP. Responsible to carry out preventive maintenance as pe SOP. Responsible to attain any breakdown within short time and in line with handling breakdown SOP. Responsible to maintain the utility equipment quality parameter within range as per SOP. Qualifications ITI/Diploma Show more Show less

We are hiring for BAG LINE PROJECT Base location: Ahmedabad Essential requirement: Experience in Project Management Preferable: Experience in handling IV Bag Line operation Key Accountabilities: Layout and Concept of Project Preparation and Approval of Project Concept and Project Definition Preparation of Project Milestone schedule Preparation and monitoring of detailed project schedule To develop and review layouts, systems, processes which meets the latest guidelines of regulatory agencies Project Financial To prepare Capex based on the realistic approach keeping the focus on overall project timelines & technologies. To timely escalate to senior management for the cost over runs or for the additional scope of work. Project Planning and Execution Preparation and approval of Planning/Schedule of overall project. Preparation, review and approval of Design Data sheet (Utility, HVAC, Electrical) Finalization of technical details of machines in consultation with all stake holders. Project monitoring, Liaison and Co-ordination with Consultant, Vendor, and Cross Functional team. To review progress of construction of facility. Preparation, Review, Approve & Authorize URS of Process Equipment. Preparation of techno-commercial comparison of Process Equipment Procurement, Installation-commissioning and Qualification of Process Equipment. Utility Utility Designing and selection as per process / product requirement. Preparation, Review, Approve & Authorize URS of Utility Equipment. Installation, commissioning and qualification of Utilities Equipment. Approval of Design Qualification/FAT/SAT/IQ/OQ/PQ (qualification protocol) and other required documents like change control, Addendum etc. Preparation of Technical Comparison of all vendors. Installation, commissioning and qualification of Entire Water system. EHS To guide team to carry out all assignments in a safe working condition at site. To inspire, motivate team & lead team from the front. To focus on bringing new technologies, processes, systems.

Amneal Pharmaceuticals is looking for Associate, Granulation to join our dynamic team and embark on a rewarding career journey Operate equipment for granulation in pharma production Monitor batch parameters and ensure quality checks Maintain records as per GMP standards Clean and calibrate machines after runs

Amneal Pharmaceuticals is looking for Senior Assistant, Granulation to join our dynamic team and embark on a rewarding career journey Lead granulation process and supervise junior operators Ensure adherence to SOPs and batch documentation Support equipment maintenance and issue resolution Participate in audits and compliance checks

Responsible for routine operations of power distribution system, D.G. Sets, HT Breakers, HT Yard, LT Breakers, switch gears and distribution panels. To Perform the preventive as per schedule and predictive maintenance as when required for all Electrical power distribution equipment s. To attend the breakdown maintenance of all Electrical power distribution equipment s like LT panels, D.G. Sets, HT Breakers, HT Yard, LT Breakers, and switch gears To attend the breakdown maintenance of Chillers, Air compressors, Boiler control system, Water system, cooling towers, and other utilities. To record daily log sheets related to Power distribution system SOPs and as instructed by supervisor for statutory requirements. To perform all the jobs with safety rules and regulation and as per cGMP. Responsible to operate the utility equipment s efficiently. Responsible to maintain the critical spares inventory for utility equipment. Responsible to provide necessary utility to production department or another user. Responsible to update and maintain all utility equipment records per SOP. Responsible to carry out all work as per cGMP and GEP. Responsible to carry out preventive maintenance as pe SOP. Responsible to attain any breakdown within short time and in line with handling breakdown SOP. Responsible to maintain the utility equipment quality parameter within range as per SOP.

Oversee and execute analytical testing of raw materials, in-process samples, and finished products. Ensure compliance with cGMP, GLP, and regulatory guidelines. Review and approve analytical data, test results, and documentation. Troubleshoot analytical instruments like HPLC, GC, UV, and FTIR. Support method validation, stability studies, and regulatory audits. Implement quality improvement initiatives and ensure data integrity

Description: The role involves ensuring CGMP compliance and operation activity in packaging area. Essential Functions: The role involves ensuring CGMP compliance and operation acitivity in packaging. Responsibilities include Operating packaging equipments and performing in-process checks during batch execution. The position requires maintaining online documents Additional Responsibilities: The role involves ensuring CGMP compliance and operation activity in packaging. Responsibilities for Operating packaging equipment and performing in-process checks during batch execution. The position requires maintaining online documents. IPQA instruments (e.g. Balance, Leak test apparatus etc.) calibration.

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.

JOB DESCRIPTION FOR SETE ENGINEERING LEAD Regular co-ordination with US CFTs and to plan, navigate and delegate work distribution amongst team members. To train, monitor, build and align the team for procedure, system and timely support of services to US CFTs. To review and co-ordinate written documentation for all manufacturing activities. These documents include but are not limited to master batch records, SOPs, Change controls and other manufacturing related documentation etc. To review and co-ordinate Process/Cleaning validation/study assignments and projects which require sound pharmaceutical/engineering skills. To review and co-ordinate validation document activities such as FAT, IQ, OQ, PQ, Re qualification protocol, Revision in qualification documents, other documents for equipment/utilities/facilities for US sites. Also support extension for rest sites in world. Prepare regular reports on performance, progress, and issues for senior management and US CFT. Preparation of departmental budget and monitoring. Guide, motivate, and supervise team members to achieve individual and organizational goals. Set goals, develop plans to achieve them, and align team activities with overall company strategy. Monitor and evaluate employee performance, provide feedback, and implement improvement plans when needed. Identify issues, analyse them, and implement solutions effectively and efficiently. Serve as a bridge between upper management and staff, ensuring information flows smoothly in both directions. Identify training needs, help with career development, and foster a learning culture. Ensure the team follows company policies, legal requirements, and safety guidelines. Participate in recruiting, interviewing, and selecting new team members to build a strong workforce. Assign tasks to the right team members based on their skills and workload, ensuring efficient execution. Communicate with clients, vendors, or internal stakeholders to manage expectations and maintain strong relationships. Create a positive work environment by recognizing achievements, encouraging collaboration, and promoting morale.

Manage operations and maintenance of ETP and STP to ensure compliance with environmental norms. - Ensure adherence to legal and statutory requirements including GPCB, CPCB, DISH, and other applicable bodies. - Lead internal and external EHS audits and ensure timely closure of non-conformities. - Implement EHS programs and SOPs across the site. - Manage hazardous waste handling, storage, and disposal as per regulatory standards. - Conduct safety drills, risk assessments, and training sessions to improve safety awareness. - Maintain accurate documentation for all EHS-related activities and compliance requirements. - Serve as the primary contact for inspections and liaison with regulatory authorities. - Drive continuous improvement initiatives in health, safety, and environmental practices. - Investigate incidents and ensure corrective/preventive actions are effectively implemented

Compilation & Review of quality ANDAs for General and Complex Injectable Products within timeline. Compilation and review of Amendments (DRL/IR/CR) within stipulated timeline for Amneal Injectable products. Review of technical documents of PD, ARD, QA, QC, Production and CRO to include as a part of Dossier. Follow up with cross-functional team for completion of assigned technical and regulatory task. Preparation of regulatory strategy/white papers and to include any critical/important missing points and finalization in consultation with superior. Primary review of DMFs of General and Complex Injectable API and follow up with purchase team for vendor documentation. Preparation and review of Controlled Correspondences for General and Complex Injectable products. Communication and discussion with CMOs for outside development projects. Co-ordination with R&D, ARD, QC, QA, Clinical, Labeling team for any outstanding technical task and escalation with superiors for resolution. Monitoring the change in regulations, regulatory procedures & guidances and to evaluate impact on product life cycle. Preparation and archival of global regulatory database.

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.