Supply Chain Digitisation & Transformation Lead and support digital transformation initiatives across Demand Planning, Supply Planning, Inventory Optimisation. Translate business requirements into SAP-enabled solutions aligned with global supply chain strategy Drive process harmonization and standardization across geographies. Identify automation and advanced analytics opportunities to improve supply responsiveness. SAP ERP & Planning Systems Lead with ownership for Planning solutions including: SAP S/4HANA (MM, PP, SD) SAP APO / SAP IBP / Kinaxis (Demand, Supply, Inventory, S&OP) Integrate planning solutions with execution systems (manufacturing, procurement, distribution) Support SAP ERP Implementation, rollouts, upgrades, and global template deployments. Ensure master data governance and data quality across planning systems. Demand Planning Develop and improve demand forecasting processes using SAP tools and statistical models Collaborate with sales, marketing, and finance for consensus forecasting (S&OP / IBP) Analyze forecast accuracy, bias, and key KPIs to drive continuous improvement Enable scenario planning and what-if simulations Supply Planning & Inventory Optimization Design and implement supply planning processes including MRP, capacity planning, and deployment Optimize inventory levels across the network to balance service and cost Support production planning and distribution planning processes Monitor supply constraints and propose mitigation strategies Stakeholder & Project Management Act as a bridge between business users and IT teams Lead workshops, requirement gathering, and solution design sessions Manage project timelines, deliverables, and change management activities Train end users and support adoption of digital tools

Key Responsibilities Strategic Leadership & Technical Oversight Drive the MSTG strategy for injectable manufacturing, aligning with corporate goals and regulatory expectations. Lead cross-functional teams in the design, development, and optimization of manufacturing processes. Provide technical leadership during product lifecycle stages including development, scale-up, commercialization, and post-launch support. Technology Transfer & Commercialization Oversee complex technology transfer projects across multiple sites or products. Ensure readiness of manufacturing sites for new product introductions through robust planning and execution. Collaborate with R&D, Regulatory Affairs, and Global Technical Operations to ensure successful commercialization. Process Validation & Compliance Lead the design and execution of process validation strategies including PPQ, cleaning validation, and lifecycle management. Ensure compliance with global regulatory standards (USFDA, EU, WHO, PIC/S) and internal quality systems. Represent MSTG during regulatory inspections and audits, providing expert technical support. Operational Excellence & Innovation Champion continuous improvement initiatives using QbD, Six Sigma, and Lean methodologies. Evaluate and implement advanced technologies (PAT, automation, digital tools) to enhance process robustness and efficiency. Monitor industry trends and regulatory changes to proactively adapt manufacturing strategies. Team Development & Stakeholder Engagement Build and mentor a high-performing MSTG team, fostering a culture of technical excellence and accountability. Engage with senior leadership, cross-functional teams, and external partners to drive strategic initiatives. Develop and deliver technical training programs for manufacturing and quality teams.

Job Description Review and process GTN adjustments based on transactions. Articulate and demonstrate mid to high level accounting knowledge and the impact of the GTN adjustments for the customer and the organization. Analyze GTN adjustments using excel based models to determine reasonableness of the transactions. Review detailed transactions and coordinate with systems and personnel to ensure all transactions are appropriately reported. Maintain a tracker of the exceptions, ensure exceptions are followed up on timely and resolved timely. Provide data and root cause analysis to support continuous process improvement initiatives Work closely with GTN US team to establish and maintain key business analytics used for daily, weekly, quarterly and yearly analysis. Support month end process to ensure a timely and accurate close. Enforce the internal compliance policy and guideline established by the management on their daily operational activities. Qualifications Key Accountabilities GTN Process Associate will partner with Pricing, Contracting, business professionals Finance Area and Audit to support continuous improvement initiatives. Expected Skills Graduate, having relevant experience. Experience working in payments and vendor administration. Oracle knowledge would be a plus for ERP Experience This position is expected to have the following skills: Working with people: build relationships at all levels and proactively communicate with employees and managers Understanding of the importance of the GTN process and how it impacts the business Mid-to-High level accounting knowledge Control (SOX) environment reporting requirements for task Demonstrated ability to foster a collaborative team environment and in developing staff Proficient written and verbal communication skills Demonstrated analytical and qualitative abilities with a keen attention to detail Highly self-motivated and directed; ability to prioritize tasks for self and for team Must have a strong customer service background Proficiency in Microsoft Office applications with strong working knowledge of advanced Excel functions Continuous improvement attitude: ability to seek out opportunities to implement best practices 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.

Job Description Import Logistics Management Handle end-to-end import clearance for multiple locations (PALLI, PIPAN, RAJODA, RAKS VIZAG, MAGNET PARK, AMNEAL ONCOLOGY, and AMNEAL US). Validate import documents and ensure timely corrections. Coordinate with vendors, internal teams, and CHA for smooth customs clearance. Arrange transportation post-clearance and ensure timely delivery. Maintain accurate records and provide final delivery updates. Ensure compliance with all regulatory requirements. Export Logistics Management Manage end-to-end export process for temperature-controlled R&D samples across all Amneal locations. Arrange bookings and prepare export documentation upon receiving user requests. Obtain quotations where contract rates are unavailable and secure necessary approvals. Coordinate with forwarders and end users for pickup and required export documents. Ensure compliance with export regulations in coordination with forwarders/CHA. Monitor timely arrival at destination, including clearance and final delivery. Coordinate with healthcare team for export shipment planning. Work with warehouses to obtain packing lists and generate invoices accordingly. Send original documents to consignees as per their specific requirements. Domestic & International Shipment Coordination Obtain shipment quotations upon receiving requests and documents. Collect at least three quotes and arrange necessary approvals as per SOP. Secure bookings with air or shipping lines based on shipment urgency. Coordinate with vendors and forwarders for documentation and timely pickup. Arrange transportation for all shipments except Ex-Works pickups. Coordinate with warehouses, forwarders, and third-party buyers for documentation and logistics. SAP Implementation Support Support SAP implementation from the logistics side over the next two years. Ensure all logistics processes are accurately mapped and integrated. Collaborate with cross-functional teams to align logistics workflows with SAP. Identify gaps and suggest improvements during system rollout. Qualifications Skills & Competencies Strong knowledge of import/export regulations and documentation. Experience in coordinating with CHA, forwarders, and vendors. Ability to manage temperature-controlled shipments. Proficiency in SAP and logistics process mapping. Excellent communication and coordination skills. Minimum 03 years of experince required , Non Pharma is acceptable 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.

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: B.Pharm / M.Sc Total Experience: 2 to 7 Years in packing department of sterile manufacturing

Job Description: The Senior Officer – Production will be responsible for operating and monitoring the Distillation Column Plant for solvent recovery and production activities in the API manufacturing unit. The role ensures safe, compliant, and efficient execution of production batches in line with SOPs, cGMP, EHS, and quality standards . The incumbent will actively support operational excellence, documentation compliance, and continuous improvement initiatives. Key Responsibilities: Execute and monitor production and solvent recovery operations in the Distillation Column Plant. Ensure strict adherence to SOPs, BMRs, cGMP, EHS, and company policies. Monitor and control critical process parameters such as temperature, pressure, vacuum, and flow rates. Perform equipment operation, cleaning, and basic troubleshooting of distillation columns and associated utilities. Ensure calibration status of instruments and report deviations promptly. Maintain accurate and timely batch records, logbooks, and stock registers. Follow good housekeeping practices (5S) and support preventive maintenance activities. Identify, report, and support investigation of deviations, incidents, and near-miss cases. Ensure proper usage of PPE and compliance with safety guidelines at all times. Participate in mandatory trainings, audits, and safety drills. Support continuous improvement and efficiency enhancement initiatives in plant operations. Coordinate with Quality, Engineering, EHS, and Warehouse teams for smooth operations. Skills & Competencies: Hands-on experience in Distillation Column operations and solvent recovery. Strong understanding of API production processes. Sound knowledge of cGMP, SOPs, and safety regulations. Ability to interpret and maintain production and compliance documentation. Knowledge of process troubleshooting and deviation handling. Familiarity with equipment calibration and preventive maintenance concepts. Good communication, coordination, and reporting skills. Strong safety awareness and compliance mindset. Qualification: M.Sc.. / B.Sc. in Chemistry Experience: 4 to 6 Years

Key Responsibilities: Responsible for Day to day supply chain planning activities Preparation of Manufacturing Plan based on sales forecast Materials planning as per requirement in manufacturing planning MRP run for materials planning Coordination with CFT team (Mfg, QC, QA, Purchase, Logistics etc) Qualification: Science/Commerce Post Graduate Experience: 3-6 yrs Having experience of Planning or materials management

Description: To lead the Chemical Quality Control function at the injectable manufacturing site, ensuring timely, accurate, and compliant testing of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples. The role ensures strict adherence to regulatory standards, drives data integrity, and maintains the readiness of the QC Chemical lab for inspections and audits. Essential Functions: To Manage the QC Chemical laboratory operations including wet chemistry, instrumental analysis (HPLC, GC, UV, IR, etc.), and stability studies. Ensure efficient resource utilization and timely release of test results as per business requirements. Ensure all QC chemical activities are performed in compliance with cGMP, GLP, and data integrity standards. Review and approve test procedures, specifications, analytical methods, and associated documentation. Lead the investigation of OOS, OOT, deviations, and implement effective CAPAs. Ensure proper maintenance, qualification, and calibration of analytical instruments. Oversee the lifecycle management of equipment including procurement, validation, and decommissioning. Lead and mentor a team of QC Chemists and Analysts, ensuring continuous development and training. Conduct periodic performance reviews and skill-gap analysis to strengthen team capabilities Ensure the QC Chemical lab is always in a state of readiness for regulatory and customer audits. Represent the QC Chemical function during audits and ensure timely closure of observations related to chemical testing. Support technology transfers, method validations, cleaning validations, and new product introductions from the chemical testing perspective. Coordinate with QA, RA, Production, and other functions for seamless quality operations. Additional Responsibilities: Lead and oversee all Quality Control (QC) activities for API manufacturing. Act as QC Lead , providing strategic direction and technical leadership to the QC team. Ensure compliance with cGMP, regulatory guidelines, and data integrity requirements . Review and approve analytical results, OOS/OOT investigations, and CAPAs. Manage QC documentation, SOPs, validation, and change control activities. Coordinate with QA, Production, Engineering, and Regulatory teams. Support internal, customer, and regulatory audits/inspections as the QC Lead representative . Drive continuous improvement, team capability building, and performance management. Education: Bachelors Degree B. Pharma - Required Master Degree M. Sc - Required Experience: 15 years or more in 15 - 20 Years Skills: Laboratory Data Management - Advanced Stability Study Documentation - Advanced Specifications & Test Methods Documentation - Advanced Analytical Method Validation Documentation - Advanced CAPA, Deviation, and Change Control Management - Mastery Training and Compliance Record Management - Advanced Knowledge of Regulatory guidelines/Requirement - Mastery Analytical evalution of vendor - Advanced Method Validation/verification Protocol Design/review - Advanced GMP Compliance for Environmental Monitoring - Mastery Documentation & Data Integrity Practitioner - Mastery CAPA, Deviation, and Change Control Management - Advanced Specifications & Test Methods Documentation - Advanced

Job Description Responsible for document handling, issuance, distribution, and retrieval of docume,verification of documents like Batch Manufacturing records, Batch Packaging Records, Protocols, layouts, specifications, Method of Analysis, Logbooks, Planner, etc. Responsible for issuance of approved Standard Formats and Logbooks to User Departments, Issuance of line-clearance checklist, interventions checklist and additional pages of BMR/ BPR as requested by user, reconciliation, retrieval and archival of issued standard formats and logbooks. To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form. To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them, to perform the additional studies and to derive the appropriate CAPA. To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA. To perform the trend analysis of deviation, change control, complaints etc.. to identify any repetitive event for further evaluation and CAPA. Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system Skills QMS Documentation (OOS, OOT, Deviation & Incident), CAPA, Deviation, and Change Control Management, Documentation & Data Integrity Qualifications B.Sc / M.Sc / B.Pharm / M.Pharm

Job Description Strategic Leadership & Business Planning Develop and implement the long-term strategy for CMO operations in alignment with business objectives. Identify, evaluate, and onboard CMOs based on technical capability, capacity, compliance history, and cost competitiveness. Establish long-term capacity and sourcing plans to support product launches and market expansion. Drive business continuity planning and risk mitigation for external manufacturing operations. Planning, Coordination & Supply Chain Alignment Lead end-to-end planning activities for CMO operations including demand planning, supply planning, and material planning. Collaborate with Supply Chain, Production Planning, and Procurement teams to ensure accurate demand forecasts and production schedules. Oversee allocation of production across CMOs based on capacity utilization, lead times, and cost considerations. Ensure alignment between internal planning teams and external CMOs for production timelines, shipment schedules, and inventory management. Monitor and review monthly production plans, capacity load, and material availability to ensure uninterrupted supply. Coordinate with vendors for timely availability of APIs, excipients, and packaging materials required for CMO batches. Review supply chain KPIs such as forecast accuracy, adherence to production plans, and material readiness. Operational Oversight & Execution Ensure smooth execution of manufacturing operations at CMOs as per approved plans and timelines. Review weekly and monthly production performance against plan and initiate corrective actions where necessary. Drive operational excellence through continuous improvement in productivity, yield, and turnaround time. Conduct periodic site visits to monitor performance, resolve operational bottlenecks, and enhance process capability. Quality, Compliance & Regulatory Management Ensure all CMO facilities operate in full compliance with cGMP and company quality standards. Partner with QA/QC and Regulatory teams for audits, product filings, and inspection readiness. Oversee quality metrics, deviations, change controls, and CAPA closures in coordination with the Quality team. Support CMO sites during regulatory audits (USFDA, EMA, WHO, MHRA, etc.) and ensure continuous compliance readiness. Technical & Process Support Collaborate with Technical Services, R&D, and Technology Transfer teams for new product introductions and process validations. Provide technical oversight for scale-up, troubleshooting, and optimization of manufacturing processes at CMOs. Ensure technical agreements and manufacturing instructions are updated and adhered to. Vendor & Stakeholder Management Serve as the primary point of contact for all CMO and vendor interactions. Conduct regular business review meetings with CMOs to evaluate performance (Quality, Delivery, Cost, and Compliance). Develop strong partnerships with CMO leadership teams to foster transparency and mutual growth. Coordinate cross-functionally with internal teams — Quality, Regulatory, SCM, Finance, and R&D — for seamless execution. Cost & Performance Management Manage CMO operational budgets and drive cost optimization through efficiency initiatives and strategic sourcing. Monitor and report KPIs: cost per batch, OTIF (On-Time In-Full) delivery, rejection rates, yield, and resource utilization. Identify and implement productivity and cost-reduction initiatives across CMOs. People Leadership Lead and mentor a team responsible for CMO operations, planning, and coordination. Build team capability in vendor management, technical assessment, and production planning. Promote a culture of collaboration, accountability, and performance excellence. Qualifications Qualifications & Experience: Education: B. Pharm / M. Pharm / B.Sc. / M.Sc. / B. Tech (Chemical / Biotech) or equivalent degree in science or pharmacy. MBA preferred. Experience: 10- 15 years in pharmaceutical manufacturing with at least 7 years in CMO operations and business development. Technical Expertise: Exposure to multiple dosage forms — Injectables (aseptic, lyophilized, BFS) and Oral Solid Dosage forms (tablets, capsules, controlled release). Skilled in technology transfer, process validation, scale-up, and capacity management. Strong knowledge of planning systems, demand & supply planning, capacity management, and vendor performance monitoring. In-depth understanding of GMP, ICH guidelines, and global regulatory submissions (IND, NDA, ANDA) with compliance exposure to USFDA, EMA, WHO, and MHRA. Experienced in leading cross-functional, multi-site operations with a focus on efficiency and compliance. Proficient in ERP (SAP), MES, LIMS, and digital manufacturing platforms, with strong expertise in supply chain and vendor coordination. Proficient in ERP (SAP), MES, LIMS, and digital manufacturing platforms with strong supply chain and vendor coordination skills. 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.

Job Description Manage end-to-end supply chain requirements for Emerging Markets (MENA, LATAM, CIS,SEA) across Trade, Tender, and Special Import channels, ensuring efficient product availability and market responsiveness. As a demand planner, drive daily coordination with manufacturing sites in the US and India to align production priorities with market demand, supporting agile and effective supply planning. Collaborate with cross-functional teams including Project Management, Artwork, and Procurement to ensure the timely launch of newly registered products in line with commercial timelines. Collect and analyze demand forecasts from regional business teams, maintaining accurate visibility into valid supply plans to support strategic decision-making. Monitor inventory at US and India warehouses, ensuring readiness for ongoing and upcoming tender participation. Prepare and present monthly MIS and S&OP decks to senior management, highlighting key supply metrics, risks, and mitigation actions. Act as the primary point of coordination between Marketing and Supply planner to ensure commercial teams have up-to-date visibility of the supply situation. Coordinate daily operational activities with Manufacturing, Logistic, Warehouse, and Commercial teams to ensure smooth execution of supply plans. Support strategic and operational SCM projects by ensuring timely data availability, issue resolution or escalation, and documentation of key deliverables and templates. Track the Sales Budget vs Actual on a monthly basis and ensure that committed Sales budget is met. Qualifications Experience - 5-10yrs 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.

Job Description Developing learning strategies, training modules and interventions. End to end learning process development. Implement various off-line & e-learning programs. OD initiatives, enable people development trough career pathing. Preparing, maintaining training budget and developing delivery vendors. Responsible for TNI, competency matrix and training calendar for all sites of Amneal India. Content development & delivery of various training programs. Track, monitor, prepare and present L & D review metrics Qualifications Qualification - MBA – HR | Certifications | ISTD Diploma | SHRM Certification Experience - 10-12yrs 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.

Job Responsibility JOB DESCRIPTION 1 Responsible for preparation of packaging planning on monthly and also daily as per the requirement and availability of materials. 2 Responsible to update on self-hygiene. 3 Responsible to attend the training as per training schedule and to ensure the training as per TNI. 4 Responsible to work as per standard operating procedures, in general area of sterile manufacturing department. 5 Responsible for preparation, review, revision, control and implementation of Standard Operating Procedures of General Area in Sterile Manufacturing Department. 6 Responsible for BPR Preparation. 7 Responsible to ensure that all equipments and lines are in validated and calibrated status. 8 Responsible to check that all the records and log books related to general area and equipment of packaging, inspection area. 9 Responsible to give training to all the subordinates, technicians and operators of the department. 10 To follow the cGMP, Good Document Practice and discipline in the department. 11 Responsible for document handling of Packing, and Inspection. 12 Responsible for monitoring of all the activities related to packing, and inspection. Qualifications Education: B.Sc., B.Pharma, M.Sc., M.Pharma Total Experience - 2 - 7 Year in sterile manufacturing plant

Job Description To optimize inventory by a thorough analysis of items with high inventory, open order etc. To reduce the non-moving inventory, by regularly chasing with API Sales, Amneal commercial team etc. To analyze supplier’s delivery accuracy and update the lead time/safety stock on a quarterly basis. To analyze on Sales forecast vs actual sales data and share the observations for better planning over and above forecast. To coordinate with Injectable/Ophthalmic CMOs for project execution and on-time delivery. To coordinate for any other cross functional projects like variation filing etc. To coordinate and provide monthly KPI presentation of the department. To make all the presentations for CEO/President. To track on capacity expansion projects with critical stakeholders. To share workload with individual team members with excessive time sensitive work. To maintain overall efficiency of the department by improving on processes. To coordinate and support on automation project with IT team/CFT. To harmonize on the processed within the department, by picking up the best practices. Qualifications Experience - Freshers - 5yrs 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.

Job Description Key Responsibilities: Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualifications Qualification: B.Pharm/M.Pharm Experience: minimum 2-5 years experience in manufacturing QMS/Process review/Compliance.

Job Description Responsible for preparation & review of the master documents of sterile manufacturing for parenteral facility. Responsible for preparation and review of protocols and reports based on the requirements. Responsible for document management and preparation like BMR’s, BPR’s, master SOP’s etc. Responsible for the handling of change control, deviations, CAPA, investigation etc. Responsible to give training to all the subordinates, technicians and operators of the department. Responsible for Audit and compliance on manufacturing shopfloor. Knowledge of kaizen and continuous improvements. Qualifications Qualification: B.Pharm/M.Pharm candidate with minimum 3-5 years experience in manufacturing QMS/Process review/Compliance.

Job Description Responsible for review of URS, DQ and vendor/ suppliers’ documents related to qualification. Responsible for preparation and review of Validation/ Qualification protocol and report. Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities. Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities Responsible for preparation and review of media fill and hold time protocol and report. Responsible for preparation of Standard Operating Procedures of Quality Assurance Department. Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.. Responsible to prepare protocols of process validation and cleaning verification/validation. Responsible to conduct sampling activity as per the protocols (Process validation and cleaning validation etc..) Qualifications Qualification - M.Sc. / B. Pharm / M.Pharm

Key Responsibilities JOB DESCRIPTION Sterile / Parenteral / Aseptic Filling, Sealing, Filtration, Production QMS Batch Manufacturing Autoclave Terminal Sterilization Packing & Visual Inspection Qualifications Qualification Requirement: B.Pharm / M.Sc Experience: 2-7 years

Job Description: The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor Key Responsibilities: Perform in-process quality assurance (IPQA) activities for API manufacturing as per cGMP requirements. Monitor critical process parameters, sampling activities, and in-process controls on the shop floor. Review and verification of batch manufacturing records (BMRs), logbooks, and production documents. Ensure compliance with SOPs, GMP, safety, and data integrity practices. Handling and documentation of deviations, OOS/OOT, change controls, and CAPA in coordination with cross-functional teams. Support internal, external, customer, and regulatory audits; ensure timely closure of audit observations. Verification of equipment cleaning, line clearance, and process adherence. Coordination with Production, QC, Engineering, and EHS teams for quality-related issues. Skills Required: Strong understanding of API manufacturing processes and IPQA controls. Excellent documentation and compliance skills. Good communication and coordination abilities. Attention to detail and problem-solving mindset. Ability to work in shifts and handle shop-floor QA activities. Qualifications: M.Sc. in Chemistry (mandatory). Sound knowledge of cGMP, ICH guidelines, and API regulatory requirements.

Job Description: The Officer – IPQA is responsible for performing in-process quality assurance activities during API manufacturing operations in compliance with cGMP requirements. The officer ensures proper line clearance, equipment cleaning verification, and adherence to GMP and safety practices on the shop floor Key Responsibilities: Perform in-process quality assurance (IPQA) activities for API manufacturing as per cGMP requirements. Monitor critical process parameters, sampling activities, and in-process controls on the shop floor. Review and verification of batch manufacturing records (BMRs), logbooks, and production documents. Ensure compliance with SOPs, GMP, safety, and data integrity practices. Handling and documentation of deviations, OOS/OOT, change controls, and CAPA in coordination with cross-functional teams. Support internal, external, customer, and regulatory audits; ensure timely closure of audit observations. Verification of equipment cleaning, line clearance, and process adherence. Coordination with Production, QC, Engineering, and EHS teams for quality-related issues. Skills Required: Strong understanding of API manufacturing processes and IPQA controls. Excellent documentation and compliance skills. Good communication and coordination abilities. Attention to detail and problem-solving mindset. Ability to work in shifts and handle shop-floor QA activities. Qualifications: M.Sc. in Chemistry (mandatory). Sound knowledge of cGMP, ICH guidelines, and API regulatory requirements.