271 Process Validation Jobs - Page 4

Date 3 Jul 2025 Location: Bangalore, KA, IN Company Alstom Req ID:489176 OVERALL PURPOSE OF THE ROLE: Defines the manufacturing process and associated equipment for a new product, taking into account the industrial policy, existing standards and constraints of the project. Perform industrial documentation for the project. Estimate the manufacturing workload for the part corresponding to his domain.e RESPONSIBILITIES: During specification and preliminary design phases: Gather Industrial requirements Engineering has to comply with, during product specification and design. Explain them to Engineering. Participate actively to the product design in co-engineering mode, using appropriate methodologies. Design the macro-process, based on standard SMP. Prepare introduction of new technologies if need be, with associated process validation plan. Identify needs of specific manufacturing equipment. Estimate Method Time and perform a preliminary line balancing. Identify critical process steps where to perform detailed Process FMEA and full FAR / FAI. During detailed design phase and before Serial Go: Complete industrial documentationindustrial data sheets, IMFU (Industrial Maturity Follow-Up) Perform P-FMEA. Participate to validation of prototypes if any. Develop specifications of industrial means for serial production. Define workstation layouts, taking into account ergonomic and EHS rules and optimizing movements. Perform a complete and detailed line balancing. Validate product design and industrialization through FAR and FAI. After serial Go: Industrialize retrofit after engineering changesdocumentation, workstation definition / update. Support Production to achieve manufacturing QCD targets. Other activities: Bring his expertise to the industrial Costing Manager during tender phase Participates to R&D programs as industrial representative. Perform industrial REX on manufacturing processes. Qualifications & Skills: EDUCATION Technical education. English read, written, spoken BEHAVIORAL COMPETENCIES: Conscientious. Commits and delivers. Team Player. Spirit of Team Trust Action Decisive. Obtains and uses necessary information to make decisions. Refers decision to others when appropriate Self-Motivation. Logical and organized Good communication. TECHNICAL COMPETENCIES & EXPERIENCE Manufacturing or Manufacturing Engineering background with 5 to 10 years experience preferably in the railway industry. Technical experience of Process Engineering, writing manufacturing work instructions, line balancing, Lean Manufacturing. Experience in working with an ERP (such as SAP) for Bill of Materials, Routings, Configuration follow-up Working knowledge in Quality, EHS standards and Ergonomics. Knowledge of CAD and PLM tools (CATIA, DELMIA) Familiar with IS common tools. Process FMEA, QRQC. EXPERIENCE / SET Manufacturing or Manufacturing Engineering background with 5 to 10 years experience preferably in the railway industry. Technical experience of Process Engineering, writing manufacturing work instructions, line balancing, Lean Manufacturing Language Skills: Proficient in English language. IT Skills: MS office tools (Word, Excel, PowerPoint), CAD and PLM tools (CATIA, DELMIA..) An agile, inclusive and responsiblecultureis the foundation of ourcompanywhere diverse people are offered excellent opportunities to grow, learn and advanceintheir careers.We are committed toencouragingour employeesto reach their full potential,while valuing and respecting them as individuals. You dont need to be a train enthusiast to thrive with us. We guarantee that when you step onto one of our trains with your friends or family, youll be proud. If youre up for the challenge, wed love to hear from you! Important to note As a global business, were an equal-opportunity employer that celebrates diversity across the 63 countries we operate in. Were committed to creating an inclusive workplace for everyone. Job Type:Experienced

Date 1 Jul 2025 Location: Coimbatore, TN, IN Company Alstom At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling, and digital mobility, we offer our diverse customers the broadest portfolio in the industry. Every day, 80,000 colleagues lead the way to greener and smarter mobility worldwide, connecting cities as we reduce carbon and replace cars. Your future role Take on a new challenge and apply your manufacturing and process engineering expertise in a cutting-edge field. Youll work alongside driven and collaborative teammates. You'll define manufacturing processes and associated equipment for new products, ensuring alignment with industrial policies and project constraints. Day-to-day, youll work closely with internal teams like Product Design Engineers, Manufacturing, Sourcing, Supply Chain, and Industrial Quality, as well as external stakeholders such as central teams and other site Industrial Data Managers. Youll also lead a team to drive and execute projects, ensuring industrial deliverables are met on time. Youll specifically take care of creating industrial documentation, estimating manufacturing workloads, and validating product designs through FAR and FAI, but also support production in achieving manufacturing QCD (Quality, Cost, Delivery) targets. Well look to you for: Gathering industrial requirements and ensuring Engineering complies during product specification and design. Participating in co-engineering activities to design processes and introduce new technologies. Developing specifications for industrial means and defining workstation layouts adhering to ergonomic and EHS rules. Performing P-FMEA and macro-process design, including line balancing and process validation. Leading validation of prototypes and ensuring smooth transition to serial production. Supporting production teams post-serial Go and managing retrofit industrialization after engineering changes. Providing expertise to the Industrial Costing Manager during tenders and participating in R&D programs. Driving continuous improvement through industrial REX (Return of Experience). All about you We value passion and attitude over experience. Thats why we dont expect you to have every single skill. Instead, weve listed some that we think will help you succeed and grow in this role: Engineering degree in Mechanical or Electrical fields. 810 years of experience in manufacturing or manufacturing engineering, preferably in the railway or automobile industry. Technical expertise in process engineering, writing manufacturing instructions, line balancing, and Lean Manufacturing. Experience working with ERP systems (e.g., SAP) for Bill of Materials, Routings, and Configuration follow-up. Knowledge of CAD and PLM tools (e.g., CATIA, DELMIA). Familiarity with IS tools, Process FMEA, and QRQC methodologies. Understanding of Quality, EHS standards, and Ergonomics. Strong leadership skills to manage a team and deliver industrial objectives. Things youll enjoy Join us on a life-long transformative journey the rail industry is here to stay, so you can grow and develop new skills and experiences throughout your career. Youll also: Enjoy stability, challenges, and a long-term career free from boring daily routines. Work with new security standards for rail signalling. Collaborate with transverse teams and helpful colleagues. Contribute to innovative projects that shape the future of mobility. Utilise our flexible and inclusive working environment. Steer your career in whatever direction you choose across functions and countries. Benefit from our investment in your development through award-winning learning programs. Progress towards leadership roles in industrialization or related domains. Benefit from a fair and dynamic reward package that recognises your performance and potential, plus comprehensive and competitive social coverage (life, medical, pension). You dont need to be a train enthusiast to thrive with us. We guarantee that when you step onto one of our trains with your friends or family, youll be proud. If youre up for the challenge, wed love to hear from you! Important to note As a global business, were an equal-opportunity employer that celebrates diversity across the 63 countries we operate in. Were committed to creating an inclusive workplace for everyone.

Long Description Role- Shift Officer - MDI Manufacturing To Supervise compliance to all CGMP or any other regulatory requirements, including EH&S requirements. Complete self-training and monitor training of team members on relevant SOP. Report any quality concerns or suggestion for improvements SOPs. Execute and supervise all tasks and activities as per the applicable SOPs. Supervision of operations, cleaning and maintenance of MDI process equipment's / area in MDI Production area of unit-3. Planning, execution, monitoring supervision of all unit operation for batch processing and Manufacturing. Co-ordination with cross-functional teams for smooth execution of production plan at shop floor. To ensure documentation of required process parameter as per SOPs. Training and development of subordinates to ensure functioning at shop floor as per cGMP requirements. To ensure status labelling of equipment, machines, area and instruments comply with the requirements. In-process checks during stage wise process as per Batch Manufacturing Record as per Standard Operating Procedure. Gap analysis of defined procedures in BMR / SOP / Protocol and initiation of corrective action. Handling of Quality Management Documents like change control, deviation, CAPA and other related documents. To ensure required inventory of approved consumables in Warehouse. To report of incident, non-conformity immediately to the manager. Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management Education Work Experience

As the Quality Management Systems (QMS) Manager at our corporate departments, you will play a vital role in ensuring the highest standards of quality across all aspects of our operations. Your responsibilities will include reviewing, approving, and closing change controls, deviations, and incidents for the corporate department. Additionally, you will be tasked with reviewing change controls for oral dosage forms across all Hetero formulations facilities. Your role will also involve reviewing Process Validations, Continued Process Verification, Cleaning Validations, Hold time studies, and Annual Product Quality Reviews (APQR) across our formulations facilities. You will be responsible for coordinating and overseeing Quality review meetings, as well as implementing and harmonizing the Quality Management system across all oral dosage form facilities. In this position, you will be in charge of issuing and controlling Critical Quality Attribute (CQA) Standard Operating Procedures (SOPs) for the respective formulation units. You will provide support for regulatory inspections in all formulation units within the Hetero group and conduct self-inspections to ensure compliance with quality standards. You will work closely with your supervisor and be ready to take on any additional responsibilities as assigned. Your role is crucial in maintaining and enhancing the quality standards that define our organization.,

As an experienced PLC Engineer with a minimum of five years of desirable experience, you will be responsible for installation, commissioning, troubleshooting, optimization, and validation of aseptic filling and packaging equipment in Food / Beverage plants. Your expertise in Siemens S7 programmable logic controllers, HMI configuration, process validation, and Logic Simulation will be crucial for the successful execution of projects. Furthermore, experience in other PLC systems like Rockwell Automation would be advantageous. Your role will also require a good understanding of different process sensors, instruments, measurements, and servo drives of aseptic filling and packaging equipment, along with proficiency in interfacing with PLC systems. Knowledge of PLC interfacing with other systems such as OPC UA and Modbus, as well as experience in Power / Water projects involving PLC-DCS-SCADA, will be beneficial. You should have a strong grasp of P&ID drawings and the ability to create and modify process graphics. Additionally, you will be expected to possess good knowledge of using test instruments for start-up and commissioning activities, as well as experience in FAT-SAT of PLC-based control systems, loop checking, and documentation of software and hardware. The role will also involve leading a team of technicians for wiring and instrument troubleshooting, necessitating strong team leadership skills. Being a good team player and having experience in working and coordinating with cross-functional engineers will be essential in this role. Your success in this position will be driven by your adherence to strong professional and personal values.,

BMR Review, BPR Review, Line Clearance, Change Control, Deviation.

To follow safety rules in the premises according to the company norms. Operation and Cleaning of glove integrity and filter integrity testers. Responsible to perform the in process checks during operation. Responsible for Dispensing, checking and receiving of PPM from warehouse on need basis. To ensure cleaning and storage of change parts as per the procedures. To maintain the BMRs and other log books in the compounding area as per cGMP and SOP Cleaning and maintenance of compounding area as per GMP and SOP Operation and cleaning of dynamic pass box in compounding area Responsible for Cleaning and sanitization of drain points in compounding area Responsible for manufacturing and supervising of Media fill and Drug products batches as per BMR To carry out CIP & SIP of the vessels related to compounding and flitration area. Responsible for operation, calibration and cleaning of weighing balance, pH meter, DO meter and conductivity meter, Compounding isolator, Manufacturing and filtration vessels, Heating & cooling skid, Air shower. Table mounted LAF and ceiling mounted LAF, Filter integrity tester, Sonicator , TFF, Homogenizer, Lipid extruder, Fogger, Heating magnetic stirrer with thermometer, SART system, Strip chart recorder Preparation and periodic revision of SOPs related to compounding area. Responsible for the co-ordination with cross functional departments like QA,QC, warehouse Engineering, HR and administration for the day to day activities. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.

Scicore Nutra Private Limited is a state-of-the-art facility, located in Sanand Gujarat, is dedicated to producing high-quality nutrition products that are safe, effective, and meet the highest standards of quality. Our team of experts is committed to ensuring that every product we manufacture is produced with the utmost care and attention to detail. At our manufacturing unit, we use only the best raw materials and employ advanced manufacturing processes to ensure that our products are of the highest quality. We also adhere to strict quality control measures to ensure that every product meets our rigorous standards. This starts with doing a rigorous vendor qualification as well as testing of all raw materials supplied by these vendors for every batch. We do in-house stability studies to make sure our products last the full shelf life and give the best results to our customers. Our goal is to provide our customers with nutraceutical products that promote health and wellness, and we are committed to using science-backed ingredients and formulations to achieve this goal. We are also committed to continuous innovation and improvement and are always looking for new ways to enhance our products and processes. Company Benefits: 1. Free Air-Conditioned Transportation to the Factory 2. Paid Leave 3. Tea/Coffee & Canteen Facility 4. Accident Insurance 5. Provision for Bonus & Gratuity 6. Training programs for professional advancement Progressive work environment conducive to personal and professional growth. Role & responsibilities 1. Assist in performing in-process quality checks during the production of nutritional food products. 2. Conduct sampling and testing of raw materials, in-process products, and finished goods such as moisture content, pH levels, or texture. 3. Review and verify batch records, ensuring that they are complete, accurate, and compliant. 4. Assist in the preparation and documentation of IPQA-related reports and records. 5. Monitor cleanliness and hygiene standards in the production area. 6. Participate in internal audits and inspections as per company requirements. 7. Collaborate with production teams to resolve quality-related issues promptly. 8. Support the quality control team in investigating and resolving any quality-related issues or deviations. 9. Ensure adherence to Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), GDP, and other regulatory guidelines. 10. To follow the procedure for In process Checks in Production & Packing area 11. Review of all documents relating to the Manufacturing & Packing. 12. IPQA of Dispensing, Manufacturing, Packaging and Dispatch activities. 13. Preparation & Review of PROCESS VALIDATION and CLEANING VALIDATION protocols and records. 14. Preparation, Review and Issuing control of BMR & BPR. 15. To follow the Sampling procedure. 16. Provide LINE CLEARANCE in MIXING AREA, FILLING AREA, DISPENSING and PACKING AREA. 17. Knowledge of APQR Data Collection. 18. Calibration and Verification of Instrument (Leak Test & Weighing Balance) 19. Overall Responsibility to Review Logbooks, In-process formats and other online records.

Role & responsibilities :- Hands on experience for BMR, Process validation report, Stability Protocol, Sampling Plan, Knowledge about GDP initiation and closure of Change control, deviation in GMP. Having good knowledge of guidelines SUPAC, cGMP, Compliance, ICH Q1A,Q2,Q7, Q8,Q9, A10, Q13. Knowledge about GAP assessment between sending unit and receiving unit equipment / instrument / documents. Hands on experience with Advanced Microsoft Word, Power point and excel Effective communication and Co-ordination with CFT. Sound Scale up/down knowledge Calculation, forecasting, Risk assessment etc. Plan Lab scale experiments and perform. Preferred candidate profile :- Must Have Experience in Tech Transfer Department Documentation. M. Pharma in Pharmaceutics Proficiency in MS- Word, Excel, PowerPoint Perks and benefits :- As per Company Standard

•Drive continuous process improvements on the assembly line to enhance productivity and reduce risk •Prepare and maintain PPAP documentation Control Plans, PFMEA, Check Sheets, etc.) •Apply quality tools and methodologies such as APQP and 7QC tools

1 Supervise & Monitor manufacturing and packaging activity. 2 To guide, supervise, co-ordinate, manage and lead a team of production officer and production operators in execution of manufacturing operation to achieve the stated goals. 3 Preparation, review and implementation of SOPs and Formats pertaining to manufacturing Department. 4 Preparation and review of URS for manufacturing department. 5 Imparting training of manufacturing SOPs and GDP to Production Operators and Production Officers. 6 Preparation and review of Performance Qualification batch record and protocol. 7 Executing and reviewing of manufacturing equipment qualification activity. 8 Execution and supervision of the Process Validation/Stability batches/Commercial batches. 9 Preparation and Review of Master Batch Manufacturing Records and Master Batch Packaging Record for Process Validation / Stability Batches / Commercial Batches and other relevant documents. 10 Review, execution and implementation of Batch Manufacturing Records, Process Study Protocols and Process Study Reports. 11 Management of day to day product related activities for timely execution of the assigned products through internal communications with internal departments like Purchase, Store, QA,QC,HR & Admin, Engineering, Maintenance team etc. and external communications with Tooling vendors and Equipment manufacturers. 12 Maintaining the department in accordance with the CGMP norms. 13 Responsible for initiation, assessment and closing of any deviation and change control regarding to manufacturing activity. 14 Work distribution to production officer and production operator. 15 Any work assigned by the Dept. head after proper training. 16 To raise the indent and capex as per requirement. 17 Activities other than defined in the are to be done, as per the requirement of HOD, by following HOD s instructions and guidance.

MISSION To lead the industrialization of the new P1 To improve the production efficiency (machine & Direct Labor) in its perimeter Capitalize and share the know-how of industrial processes in his domain To participate on the design of new equipment and new lines To lead Lean design workshop Industrialization To manage production equipment introduction using IPROM To follow equipment or assembly lines development with the supplier To design small tool and validate the supplier proposal To define the acceptance criteria for new equipment or line To perform pre acceptance and acceptance of the equipment To perform trials on the lines and deliver reports To built action plans and follow up to be ready for FDPR To perform and/or collect, capabilities of equipments and process To set up equipment and propose PROCESS VALIDATION PLAN To participate on PFMEA and CONTROL PLAN Mass production To monitor QCDM and propose improvement To survey the performance of equipments , and always in mind, optimization To work on Cycle time reduction to optimize investments, material & labor costs To update routing on Information system with SPV validation To support production technician ( training, analysis, problem solving) To be in contact with the suppliers ( improvement, support) To participate to SPV workshop To participle to APU QRQC Standardization Validate PG RAISE and CdC standards which are created by Standard Owners Validate any change of standard proposed by sites To know, apply and promote the standards ( PG, sites or corporate) in his domain To apply the SPV rules Environment Ensure the respect of Safety and Environment procedures of Valeo Group Maintain the 5S and report issues Alert for safety rules infringement Job: Process/ManufEngineering Engineer/Technician Organization: Process/Manufacturing Engineering Schedule: Full time Employee Status: Regular Job Type: Permanent contract Job Posting Date: 2025-07-07 Join Us ! Being part of our team, you will join: - one of the largest global innovative companies, with more than 20,000 engineers working in Research & Development - a multi-cultural environment that values diversity and international collaboration - more than 100,000 colleagues in 31 countries... which make a lot of opportunity for career growth - a business highly committed to limiting the environmental impact if its activities and ranked by Corporate Knights as the number one company in the automotive sector in terms of sustainable development More information on Valeo: https://www.valeo.com

Job Description Rev. no.: 00 Followings will be the responsibilities of the position holder: 1. Act as receiving team for new and reformulated product from I&D to AHPL Baddi. 2. Scale up/scale down for new and existing products. 3. Preparation of MMD of new and existing products. 4. Review of sampling plan for engineering & process validation. 5. Technical inputs for product improvisation w.r.t equipment and process, formulation, or shelf-life changes through appropriate QMS. 6. Handling of reprocessing, reworking of existing formulation. 7. To support for failure investigation or exceptions (as per applicability) OOS/OOT observation. 8. All documentation & process steps for trial/non-commercial batches manufactured in production facilities. 9. New/ Old material approval (API/Excipient) - Technical input if required, revision of TD & BD limits. 10. Products externalization/ internalization from AHPL, Baddi to LL/ TP and vice versa. 11. Preparation of Standard operating procedure (SOPs) pertaining to department. 12. Analytical/Formulation support (troubleshooting) for existing products (including method development). 13. Cost saving initiative related to formulation and process. 14. To support in document preparation, review and approval of documents related to production. 15. To ensure overall compliance related to technical operation and production department. 16. To review and approve documents wherever approved chemist review and approval is required, In absence of the position holder, the sub-ordinate Executive / Manager working in the section or the authorized designee (as applicable) shall be responsible for day to day working. Signatures _____________ Position holder ______________________ Authorized by JOB FAMILY: Supply Chain t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Job Description Executive IPQA M. Pharma/ B. Pharma. Minimum 5 Years Experience in solid dosage form- Tablets (Hormone) Person shall be well versed with manufacturing and packaging operations, Compression Machines, Isolators, Blenders, Bulk packing lines, & Process Validation. Person with Experience in Hormone Facility shall be preferred. Followings will be the responsibilities of the position holder: Ensure compliance to cGMP Regulations, established SOPs, FO/MI and PO/PI and for all operational activities, area and equipment. Perform QA review of executed batch production records and ensure the submission of Batch production record in the document cell. Calibration & maintaining documentation of In-process Quality Assurance (IPQA) instruments. Data back-up activities of IPQA instruments as per defined SOP frequency. Monitor the environmental conditions mentioned in the batch production record and SOP. Certification of batch production records for compliance and stage-wise compliance. Reporting any GMP related discrepancies, non-conformances and deviations to superiors immediately. Collection and entry of data for APR preparation. Line Clearance: Ensure physically that the area and equipment to be used for manufacturing and packaging of next product/batch are free from any material/remnants of previous product. Ensure to prevent mix up and cross contamination. Check for proper environmental conditions with respect to temperature, Relative humidity, differential pressure etc. Ensure that the Batch Production record is completed up to the previous stage. Verify the material with respect to the container labels and quantity from the batch production record. In-Process Checks: Ensure the calibration of instruments for in-process checks. In-process checks as per the approved manufacturing and packaging instructions. Enclose all the printouts generated during in-process checks along with the batch production record. All printouts shall be duly signed after checking. Inform the production manager, supervisor and quality assurance manager about the in-process failure observed during in-process checks. To record all the observations in the Batch Production Record Inspection: Inspection of the Tablets/Capsules as per SOP. Inspection of the Finished Goods as per SOP and clearance of Transfer Ticket by ensuring the quantity and batch details. Sampling: Ensure for usage of appropriate sampling tool for sampling. Ensure sampling device cleaning prior to the sampling. Sampling procedure to be followed as per SOP No. SOP019995 (Sampling of intermediates, finished product and stability samples) & SOP020059 (Collection and shipment of Analytical samples of EU market). Ensure sampling of in-process finished product, process validation, cleaning validation, control samples, EU Lab testing samples & stability samples, Reference & Retention sample as per SOP. Approval: Approval of coding pattern on immediate pack and secondary pack to be verified as per the approved packaging instructions / written procedures. JOB FAMILY: Operations Quality t

Literature search, product understanding, data interpretation for product to be undertaken for development. Design of primary product strategy, preparation of product strategy for discussion with group leader/team leader. Planning and execution of product development work to achieve desired product profile and data compilation Scheduling the work plan in consultation with group leader/ reporting authority for timely completion of the projects based on priority assigned. Execution and evaluation of various formulation optimization trials and process optimization trials and data compilation Laboratory notebook writing and assistance in documentation of controlled documents and compilation of the development data Execution of scale up, exhibit batches, characterization batches, process validation batches and commercial batches at manufacturing locations. Preparation of document for smoothly execution of scale up and exhibit batches like Justification of specification, QbD elements, MFC etc

1.Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments. 2.Resopnsible for investigation of LIR (Incident / OOS/ OOE). 3.Analysed data review. 4.Analysis of Finished, In process, Process validation, Cleaning Validation samples. 5.To report any OOS/Incidence results to immediate supervisor/Head of department.

Followings will be the responsibilities of the position holder: 1. Act as a receiving team for new and reformulated product from I&D to AHPL Baddi. 2. Scale up/scale down for new and existing products for review the occupancy in RMG and Blender. 3. Preparation of MMD of new and existing products. 4. Review of sampling plan for engineering & process validation. 5. Technical inputs for product improvisation w.r.t equipment and process, formulation, or shelf life changes through appropriate QMS. 6. Handling of reprocessing, reworking of existing formulation. 7. To support for failure investigation or exceptions (as per applicability) 8. All documentation & process steps for trial/non-commercial batches manufactured in production facilities. 9. New/ Old material approval (API/Excipient) - technical input if required, revision of TD & BD limits 10. Products externalization/ internalization from AHPL, Baddi to LL/ TP and vice versa. 11. Preparation of Standard operating procedure (SOPs) pertaining to department. 12. Analytical/Formulation support (troubleshooting) for existing products (including method development). 13. Compete projects identification and execution. 14.Floor execution/Documentation of proposal or technical write up. In absence of the position holder, the sub-ordinate Executive / Manager working in the section or the authorized designee (as applicable) shall be responsible for day to day working. JOB FAMILY: Supply Chain t SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Testing of Raw Materials , Finished samples , In process Samples and process validation ,using current pharmacopoeias, Standard Test Procedure and Specifications. Supporting all QC activities. To ensure that Equipment/Instrument in the QC Department are qualified, calibrated and under regular schedule of calibration as per SOP. Reporting to Quality Head. Preparation of test solutions, compounds and reagents for laboratory personnel to conduct test. Sampling of Raw Material as per SOP

Executive-CQA Long Description 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 3. Customer Centricity 4. Developing Talent 5. Result Orientation Work Experience 5 - 8 years

Executive-CQA-VQG 1. To perform and track the Vendor Qualification Compliance and review for all vendors & AVDs. 2. To review, approve, and extend the Q info for new alternate vendors. 3.To execute vendor Audits, CAPA tracking, and qualification documentation 4.To schedule and monitor the Vendor Audits 5.To work on VQ special projects in coordination with Project IT team 6.To track the project till its implementation and Go Live across all sites Competencies 1. Strategic Agility 2. Innovation & Creativity 4. Developing Talent 3. Customer Centricity 5. Result Orientation Education Masters in Chemistry Post Graduation in Pharmacy 5-8 YearsWork Experience

Job Description Responsible for Toxicological assessment of genotoxic and nitrosamine impurities. Responsible to support the development of nitrosamine and other genotoxic impurity risk assessment and carryover limits. To support the site management team in reviewing cleaning, nitrosamine and genotoxic impurity and keep sites up to date according to current regulatory requirement /expectation. Reviewing Permissible Daily Intake, Occupational Exposure Limits, Toxicological Justification, Quality Risk Assessment document. Responsible for preparation and revision of corporate procedures like SOP related to the assessment of potential carryover or cross-contamination of genotoxic/carcinogenic impurities. Harmonization of Cleaning and validation procedures across all sites of Lupin. Work Experience 10-12 years Education Masters in Science Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility

Job Description Batch Manufacturing and Filling activity. Batch manufacturing experience of Solution, Emulsion, suspension and gel eye drop products. Preparation and review of Deviation investigation, Risk Assessment, Impact Assessment, Equivalency reports, URS and various other production related documents and monthly intervention reports. Responsible for audit preparation (Internal and regulatory) and compliance. Reconciliation of product at various stages of batch manufacturing and filling. Preparation and reviewing of SOP and compliance after implementation. QAMS related activity. Approved GMP trainer for provide training to team members. Preparation of Media fill BMR. Planning for production activities by coordinating with PPIC, PDL, Engineering, validation and QA. Work Experience 8 to 10 Years Education Graduation in Pharmacy Competencies Developing Talent Innovation & Creativity Result Orientation Strategic Agility Process Excellence Customer Centricity Collaboration Stakeholder Management

BD & provide technical support. Handle Multistep Synthesis. Peptides Synthesis using Solid Phase Peptide Synthesis. Design & synthesis of small molecules in API. Handling synthesis of organic chemical reactions.Knowledge on Instrumentation is a must. Annual bonus Provident fund Health insurance

Division Department Sub Department 1 Job Purpose To execute the activities that are related to microbiology laboratory. Key Accountabilities (1/6) I. Involvement in all quality related activities. Maintenance of all the area and the equipment. To ensure and monitor compliance with GLP and cGMP as per requirements of the respective authority. Key Accountabilities (2/6) II. Environment monitoring Monitoring of area to be carried out as per allocated schedule. Release and transfer within the timeframe mentioned in SOP. Follow the written procedure for Execution of aseptic process validation and testing of Aseptic process validation sample. Involvement in process Simulation. Key Accountabilities (3/6) III. Media, PST management Stock of media and presterilized items to be maintained. Issuance to be done as per requirement Key Accountabilities (4/6) IV. Water and MLT Water Analysis to be carried out as per schedule MLT to be carried out as per planning. Pathogen Continuation and releases should be on time Should ensure completeness of entries of all the tests performed and compilation of relevant data before submission for review. Disposal of balance samples after completion of analysis and review Key Accountabilities (5/6) V. Training To be present in any arranged scheduled training by the trainer. LMS training to be caried out before due date. Key Accountabilities (6/6) Major Challenges Releases of all the activities carried out should be on time. Maintenance of stock in the laboratory. Decontamination of material should be on time. Key Interactions (1/2) I. Internal Interaction with team members for all related activities including handover during shift changeover. Key Interactions (2/2) II. External Interaction with service engineers during AMC and laboratory visits. Interaction with external party during external calibration and validation of equipment. Dimensions (1/2) Should have basic knowledge of microbiology and relevantly qualified. Dimensions (2/2) Key Decisions (1/2) Decisions: Suggestions and ideas for work simplification. Connecting with external Subject Matter Experts/ senior leaders within Cipla. Key Decisions (2/2) Education Qualification Educational qualifications: Post Graduate in Microbiology Relevant Work Experience Relevant experience: 2 - 5 years in pharma, microbiology. Good Knowledge about pharma process 2-5 years (Quality section) Good knowledge about computer (Excel, PPT and word file)

As a Solution Tester, you will be responsible for: 1. Designing and automating test suites to ensure reliability of the system z(s390x) platform technology 2. Having a client-first mindset to test at scale and imitate customer-like environments 3. Creating strategies and scripts to test new features and functionalities 4. Contributing and reviewing code for internal and external repositories 5. Documenting processes (Test plans) and procedures for clarity and reproducibility 6. Interacting with counterparts in US/Germany teams and Red Hat Required education Bachelor's Degree Required technical and professional expertise Required Technical and Professional Expertise with relevant experience of 6-9 years: 1. Comfortable working with any of the three major Linux distros (Redhat, Sles, Ubuntu). Preferably on a Z system (s390x) 2. Knowledge on Web Services, API Testing 3. Understanding of virtualization and containerization concepts. z/VM and KVM are preferred. 4. Experience building pipelines for automation servers such as Jenkins etc 5. Skilled in a scripting language. Python, Ansible or bash is preferred. 6. Quick learner and a strong team player with good communication and interpersonal skills 7. Self Driven and Proven ability to work effectively in a global team environment. 8. Good decision making skills 9. skills on z/OS, CICS,Db2,IMS,MQ,DFSMS VSAM & VSAM ,RLS Preferred technical and professional experience 1. Leading and Guiding Team. 2.Providing direction and support to the team to achieve shared goals. 3. Taking initiative and anticipating needs or challenges before they arise