Job Description Summary Analyst required for testing of finished product analysis, expertise in handling HPLC, GC, Dissolution apparatus. Job Description Should have exposure on finished product analysis Should have exposure on injectables analysis (Physical parameters) HPLC, GC analysis and should have exposure on instruments HPLC, GC, Auto titrator, IR and HPLC/GC trouble shooting. Should have exposure on Audit like USFDA, MHRA, TGA etc. Should have good communication and documentation skills and awareness on concept of data integrity.

Job Description Summary This is an already approved position as per the FY 2025 budget Job Description To carry out the Dispensing of raw materials, packing materials, consumable etc., Weighing, Counting activities as per SOP.. Handling the warehouse documents as per GDP Practices. To carry out the Issuance of consumable activities as per SOP. Abide to the daily operations prerequisites of operations at Warehouse. Updating of required software for material inventory control transactions. To carry out and updating the environmental monitoring and cleaning logs of warehouse. Responsibility to ensure cGMP compliance and for the development of warehouse procedures and personnel according to the said procedure. To carry out the cleaning of equipment’s, daily & monthly calibration of Balances. To carry out daily operations and ensure the assigned works are continuously maintained and achieved. To carry out daily operations and ensure works allotted from superiors on routine basis are complete and inline to the laid down procedures. Ensure the necessary safety precautions to be followed in handling of Materials and Solvents. To carry out the operations in accordance with health, safety and environmental policies and procedures to ensure the safety and well-being of the people.

Job Description Summary Supporting the Warehouse Head in overseeing daily warehouse operations, managing staff, ensuring accurate inventory, and collaborating with other departments to optimize logistics. They assist with tasks like receiving and storing goods, coordinating routine warehouse activities, and ensuring compliance with company regulations. Job Description Supervision and Management: Assist in managing warehouse staff, including training, scheduling, and addressing performance issues. Inventory Control: Help maintain accurate inventory records, ensure proper storage of goods, and monitor stock levels. Logistics Coordination: Coordinate routine warehouse activities like picking, packing, and dispatching, ensuring efficient workflows. Operational Support: Assist with receiving and storing incoming items, managing order fulfillment processes, and handling customer inquiries. Safety and Compliance: Promote and ensure adherence to company health and safety regulations. Process Improvement: Identify areas for improvement in warehouse operations and contribute to the implementation of best practices. Collaboration: Work with other departments, such as procurement, transportation, and customer service, to integrate logistics with business operations. Problem-Solving: Address operational challenges, resolve issues on the warehouse floor, and make strategic decisions to optimize processes. Leadership: Provide guidance and mentorship to warehouse staff, fostering a culture of teamwork and continuous improvement.

Job Description Summary To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. Job Description 1. To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. 2. To perform sampling in each stage or whenever required during product manufacturing, filling and packaging activity. 3.Inprocess checks of Manufacturing, Filling and Packaging. 3. To Perform the AQL after completion of visual inspection of products. 4.To perform audit trail & electronic data review batch wise and as per schedule. 5.To handle the control sample and stability sample management. 6. To Involve in Qualification of master kit approval for Visual Inspection Activities. 7.To Review and approve all the documents relevant to visual inspector qualification.

Job Description Summary To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. Job Description 1. To perform IPQA activities at shop floor in each and every stage of sterile manufacturing and packing. 2. To perform sampling in each stage or whenever required during product manufacturing, filling and packaging activity. 3.Inprocess checks of Manufacturing, Filling and Packaging. 3. To Perform the AQL after completion of visual inspection of products. 4.To perform audit trail & electronic data review batch wise and as per schedule. 5.To handle the control sample and stability sample management. 6. To Involve in Qualification of master kit approval for Visual Inspection Activities. 7.To Review and approve all the documents relevant to visual inspector qualification.

Job Description Summary We are seeking a detail-oriented and innovative Automation Engineer to join our Quality Department. The ideal candidate will be responsible for reviewing, implementing, and maintaining automated systems and tools that enhance quality assurance processes, improve product reliability, and ensure compliance with industry standards. Job Description Review and support the validation of computer systems for GxP systems at Endo India (Par Formulations), Indore SEZ plant. To review system capability to meet GAMP 5 requirement & 21 CFR requirement for electronic data management. To review the vendor investigation/assessment and corrective action incase of software failure. To involve in to the investigation/risk assessment in site automation systems. Ensure data storage, archival, and retrieval capabilities meet requirements in all GxP systems. Prepare, review and approval of documentation for automated systems, including SOPs, validation protocols as per GAMP 5 & 21CFR requirement. Collaborate with cross-functional teams (Engineering, Production, IT) to integrate automation into existing workflows. Ensure compliance with relevant regulatory standards (e.g., EU, FDA, GMP etc.). Conduct training sessions for quality and production staff on automation tools and best practices. Implement automated testing frameworks and tools for product validation and verification. Develop and review User Requirement Specifications (URS) for GxP systems concerning control and automation needs. NA

Job Description Summary The Senior Manager, Quality Control Microbiology is responsible for overseeing the day-to-day operations of the Microbiology laboratory operations. Supervision and enforcing cGMP’s, GLP’s, conducting investigations, verification of compendia methods and training of new employees. Additional responsibility includes building the data integrity aspects in the tasks performed at the lab and responsible to comply to 21 CFR part 11 of lab instruments. Job Description The Senior Manager, Quality Control Microbiology is responsible for overseeing the day-to-day operations of the Microbiology laboratory operations.

Job Description Summary Analysis of finished product and stability sample Experience on all the instrument like HPLC/GC/Spectroscopy. Job Description Analysis of finished product and stability sample Experience on all the instrument like HPLC/GC/Spectroscopy QMS knowledge/CGMP /Data integrity Ready to work in all shifts. Good communication skill US FDA Audit Exposure

Job Description Summary The Associate Director – HR Business Partner (HRBP) to support our R&D and Corporate Office functions. This role will play a critical part in partnering with business leaders to shape and execute the people strategy, drive organizational change, and support talent development initiatives that align with our overall business objectives. Job Description Key Responsibilities: Strategic HR Partnership: Partner with R&D and corporate leadership to align HR strategies with business objectives. Provide insights and solutions on organizational design, workforce planning, and talent management. Talent Management & Development: Lead talent reviews, succession planning, and leadership development initiatives. Identify skill gaps and collaborate with L&D to implement targeted development programs. Performance Management: Guide the performance management process, ensuring alignment with business goals. Coach managers on feedback, goal setting, and performance improvement. Change Management: Lead HR aspects of organizational change, including restructures, integrations, and process improvements. Act as a change agent to support transformation initiatives. HR Operations & Compliance: Ensure HR policies and practices are compliant with local laws and aligned with company values. Employee Engagement & Culture: Drive employee engagement strategies tailored to R&D and corporate functions. Champion a culture of innovation, collaboration, and continuous improvement. Projects / Initiatives & Strategy: Partner with team in the implementation of the strategic HR Plan, projects and initiatives that add value to both our business and employees. Acts as the performance improvement driver and provokes positive changes in the people management Manages HR Projects cross-functionally. Education & Qualification: MBA HR with 14+yrs of experience as a HRBP / HR Generalist

Job Description Summary Sr. Technical Assistant for Unit Preparation, Autoclave & Terminal Sterilization area. Job Description 1. Prepare and Review of unit preparation, autoclave, Dispensing, Compounding & Filtration related documentation ensure that company code of conduct is followed on the shop floor. 2. Ensure to adhere with cGMP and ALCOA in daily life cycle and to adhere with organization policies and procedures. 3. Work with Quality function in understanding and implementation of PAR Quality Management Systems (QMS) in operations. 4. Aware about data integrity principle.

Job Description Summary To perform the analysis of in process sample, Hold Time, finished product, Swab & stability samples. To prepare documents (SOP, Protocol, Format, STP, Specification, GTP, work sheet, COA and Report) whenever required. To upkeep the laboratory working area, documents and records neat and tidy. Receipt and storage of samples in QC sample room. To attend and completion of trainings in Compliance wire on timely basis. Timely reporting of incident, deviation, OOS and OOT etc. to group leader or designee and support in Laboratory Investigation. To ensure timely destruction of samples as per standard operating procedure. To take up allocated work assigned by group leader or designee for laboratory operations. To ensure lab compliance during daily activities and follow safety, cGLP and cGDP in work area. To perform the calibration of instrument before execution of activities whenever applicable. Responsible for execution of analysis and sign off activities in software on timely manner wherever applicable. To perform concurrent documentation of analytical records, storage of raw data, online entries in instrument/Equipment usage logbooks. To be responsible all-time readiness for inspections or any audit conducted by regulatory authorities. Follow all the safety procedures to maintain a safe working environment. To monitor the employee’s safety aspects and guide them safety related importance. Any non-conformity with regard to Environment Management System should be highlighted. Responsible for temperature and humidity monitoring of stability chambers; and to address the failure whenever applicable. To perform the analysis of Analytical Method Transfer, Market Complaint And Miscellaneous sample To Perform Sampling And testing of cleaning swab samples To ensure timely destruction of finished/In process/Swab/Stability/Hold time studies samples as per standard operating procedure Job Description NA

Job Description Summary Senior Associate for the PFS filling line with Isolator System Job Description Operational Oversight: Manage and monitor the filling and inspection processes for pre-filled syringes (PFS) within an isolator environment. Ensure smooth production operations across all assigned shifts. Person should be having the knowledge and skill about Sterile Injection facility. Compliance and Documentation: Maintain adherence to cGMP guidelines, regulatory standards, and SOPs. Prepare and review batch manufacturing records, deviations, and CAPA documentation. Equipment Management: Oversee the operation, cleaning, and maintenance of isolator systems, filling machines, and related equipment. Coordinate with maintenance teams for timely resolution of technical issues. Team Supervision and Training: Lead and train the team to ensure productivity and compliance with safety protocols. A person should have fundamental knowledge of quality management systems and be proficient in documentation activities, including the preparation of protocols, reports, and batch manufacturing records.

Job Description Summary Supervisor for Aseptic Filling Operation and Lyophilization (Freeze dryer) Job Description Supervision of aseptic filling operation of vial and PFS. Independently handle the vial/PFS filling line with isolator as a shift InCharge. Handle basic trouble shooting of aseptic filling lines. Handling of Cleaning and sanitization activities inside Grade-C & Grade-D area Handling of interventions inside Isolator Grade A by Grade-B Aseptic behavior inside Grade-C Area Material requisition for the PPM and Consumables for the Batch Activity Document Preparation and review process Shift supervision and manpower management in the shift

Job Description Summary Handling of utilities of injectable including regulatory and statutory compliance knowledge facility management . Job Description Project Leadership: Lead end-to-end execution of greenfield/brownfield injectable facility projects, including design, budgeting, procurement, construction, commissioning, and qualification. Utilities Oversight: Ensure uninterrupted and compliant operation of critical utilities—WFI, Pure Steam, RODI, HVAC, Compressed Air, Nitrogen, and chilled water systems. Regulatory Compliance: Ensure all systems and documentation meet cGMP, GEP, and regulatory standards (USFDA, EU-GMP, WHO-GMP). Prepare for and support audits and inspections. Cross-Functional Collaboration: Work closely with QA, Production, Validation, and EHS teams to align project deliverables with operational and compliance needs. Vendor & Contractor Management:Evaluate and manage third-party vendors, consultants, and contractors to ensure timely and quality project execution. Sustainability & Energy Efficiency: Drive initiatives for energy optimization, water conservation, and sustainable engineering practices. Team Development: Mentor and lead a team of project engineers and utility specialists. Foster a culture of accountability, safety, and continuous improvement.

Job Description Summary Sound knowledge on Handling of HVAC and utilities related to injectable . Job Description HVAC Systems Management: Design, implement, and maintain HVAC systems to meet cleanroom classifications (ISO 5–8) and regulatory requirements (USFDA, EU-GMP, WHO-GMP). Utilities Oversight: Manage critical utilities including WFI, RODI, Pure Steam, Compressed Air, Nitrogen, and chilled water systems. Ensure continuous availability and compliance with pharmacopeial standards. Preventive & Breakdown Maintenance: Develop and execute preventive maintenance schedules. Lead root cause analysis and corrective actions for equipment failures. Regulatory Compliance: Ensure all systems and documentation comply with cGMP, GEP, and audit requirements. Participate in regulatory inspections and internal audits. Project Management: Lead utility and HVAC-related projects including capacity expansion, energy optimization, and technology upgrades. Team Leadership: Supervise and mentor a team of engineers and technicians. Foster a culture of safety, quality, and continuous improvement. Documentation & QMS: Maintain SOPs, calibration records, change controls, and deviation reports. Work within QMS platforms like Track wise or SAP.

Job Description Summary Experienced in Packing & Injectable Visual Inspection operations with strong expertise in SOP/URS documentation, audit responses, and equipment qualification documentation. Job Description Packing & Injectable Visual Inspection working experience, SOP, URS Documentation Audit response Equipment qualification documentation

Job Description Summary Experienced in Packing & Injectable Visual Inspection operations with strong expertise in SOP/URS documentation, audit responses, and equipment qualification documentation. Job Description Packing & Injectable Visual Inspection working experience, SOP, URS Documentation Audit response Equipment qualification documentation

Job Description Summary This role requires 1 to 2 years' experience. with post-graduation in Chemistry. This job will involve in Analytical support for impurity and nitrosamines synthesis and qualification. Job Description Analytical Method Development, Routine Analytical Support for allotted project Responsible for qualification standards and control for allotted projects To support externals and internal (PD Lab work) queries To support Nitrosamine and impurity qualification. Responsible for daily calibration, document control and compliance. To support the queries for allotted project (API) timely To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab. To ensure cleanness of analytical instruments and working area and update all tag. To analyze RM, in process, Intermediate and API in time. To develop the suitable analytical method and make STP in time. To perform Partial validation, Holding study, DMF queries and physiochemical studies. To support stability sample analysis as per schedule. To ensure completion of documents & data integrity and regulatory environment.

Job Description Summary Handling of electrical activity. Job Description Electrical Maintenance: Ensure uninterrupted power supply and maintain all electrical systems, including HT/LT panels, transformers, DG sets, UPS, and PLC-based systems. Equipment Support: Troubleshoot and maintain electrical components of autoclaves, vial washing machines, filling lines, HVAC systems, and water systems (WFI, PW, PS). Compliance: Adhere to cGMP, GEP, and safety standards during all maintenance activities. Documentation: Maintain logs, calibration records, preventive maintenance schedules, and breakdown reports as per regulatory norms. Project Execution: Support installation and commissioning of new equipment and electrical infrastructure upgrades. Energy Management: Monitor and optimize energy consumption across the plant. Audit Readiness: Ensure readiness for regulatory audits (USFDA, MHRA, WHO, etc.) by maintaining compliant electrical systems. CIEG inspections Energy Audits USFDA Injectable exposure are added advantage

Job Description Summary The Regulatory Affairs Senior Associate is responsible for the preparation, compilation, evaluation and submission of ANDAs & Amendments to USFDA and handling deficiencies with timely submission of responses to agency. Job Description Coordinate with cross functional team/stakeholders (R&D, Quality, manufacturing, SCM, IP, PM) and vendors as required and evaluation of documents in-line with the current regulatory requirements Review of Product Development Report, Executed and Intended Batch Records, Specifications, Analytical Procedures, Method Validation Protocols and Reports & Certificate of Analysis of API/Excipients/In-Process/Finished products/Packaging materials, stability protocols and reports. Review of vendor documents of API, Excipients and Packing materials Review of documents for adequacy (w.r.t content, requirements, legibility, PDF requirements, etc.) Preparation, review and compilation of ANDAs, Amendments and Supplements in eCTD format. Coordinate with Regulatory Operation team member for uploading the submission in e CTD software Review of exported submission shared by Regulatory Operation team for submission. Monitor the FDA website for any updation. Education & Experience :- Master of Pharmacy in Dept. of Pharmaceutics Total experience of 3-5 Years in Regulatory Affairs