68 Urs Jobs - Page 2

Key requirements for this role are as follows: Excellent Communication skills Stakeholder comms Progress updates Comms related to Risk/Issue Outstanding Planning skills (using Agile/SAFe) Scope Clarity and Goal Setting Art of breaking down the work Estimation Work Allocation Risk and Dependency Management Strong Tracking and Monitoring Tracking progress Identifying and Raising Risks Behaviours Accountability/Ownership demonstrated Ability to work cohesively with people/teams Domain Should have preferably worked in Capital Markets Mandatory Competencies Agile - Agile FS Domain - Capital Market Beh - Communication

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAMP5, 21CFR Part 11, and good documentation practices - Knowledge on HP ALM and Jira Tool and validation approval process using ALM

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Role & responsibilities Performance Tuning & Code optimization. Demonstrated ability to debug and troubleshoot complex performance issues. data archiving concepts as well as experience in data retrieval from archive DB. Should be able to design and implement scalable and performant solutions. Experience with S/4 HANA Extensibility (in-app / on-stack) Strong in ABAP Technologies - ABAP Workbench, Reports, Screens, Performance Tuning. Must be able to work as a team player and can work independently. Possess exceptional interpersonal and communication skills including verbal, written presentation and listening. collaborate with cross-functional teams and stakeholders. Handle data migration tasks and transform data from the current SAP system to the S/4 HANA database. Analyzing and adapting custom ABAP code to ensure compatibility with S/4 HANA and optimizing performance.

SAP FI - Treasury Risk and Cash Liquidity Mgmt - Expert proficiency in SAP FI Treasury - Ability to read through the customer business processes and simultaneously formulating the adoption of the best business practices in meeting the foreseeable challenges Ability to review, validate the right set of questions Create solution workshops with senior business managers, review validate solutionproposals and estimates, rendering advice on best business practices and getting the buy in to adopt these practices Ability to create solution road maps integrating multiple disparate processes Ability to present and get the buy in forthe solution from senior managers Implement the solution by leading the team In addition to leveraging the standard processes, come out with innovative solutions and timely execution of the project within the agreed time lines Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the overall strategy of the line of business / business unit Quality control and Customer satisfaction Support the completion of Annual Customer Satisfaction survey by ensuring completion of survey by the account customers, representatives for various projects within the account. Ensure completion of survey and address any queries in a timely manner. Support in conceptualizing the action planning by communicating with clients and interacting with Delivery Managers, vertical delivery heads and service delivery heads Drive the account wise tracking of action planning identified for sustained CSAT in various projects. Drive the Quarterly pulse survey for selected accounts or projects for periodic check-ins. Support the Account Leadership teams for tracking and managing client escalation for closure. Early Warnings and Business partnership Drive the implementation of mechanisms for preventing client escalations / dis-satisfactions by creating an early warning system in DigiQ covering aspects like delivery quality, delivery schedule, resources constraints, financial issues (overloading of effort / over-run potential), productivity, and slippages on milestones. Participate in Monthly and Quarterly Business review along with Business and Account leadership to ensure adherence of defined quality processes, define new life cycle models and ensure gating processes are followed the projects within the accounts. Drive the upskilling of delivery teams on quality management tools, knowledge management and create mechanisms for sharing of best practices. Support the collection of metrics on the performance / health of process and regular publishing of compliance and metrics dashboards. Continuous Improvement Drive a culture of continuous improvement in the assigned accounts to ensure enhance efficiency and productivity of resources Create mechanisms between the projects in the account for sharing knowledge, quality issues, risk mitigation methods within the accounts to drive the continuous improvement Plan and drive year on year improvement goals in various projects by way of process streamlining & improvements and automation, leading to cost savings and / or efficiency Support the collection of metrics to show the improvements- efficiency / productivity improvement. Team Management Team Management Clearly define the expectations for the team Assign goals for the team, conduct timely performance reviews and provideconstructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop theirprofessional competence Drive geography specific trainings for the quality team, designed basis the statutory norms that apply in different countries Ensure that the Performance Nxt is followed for the entire team Employee Satisfaction and Engagement Lead and drive engagement initiatives for the tea Track team satisfaction scores and identify initiatives to build engagementwithin the team Deliver No. Performance Parameter Measure 1. Quality Control and Customer satisfaction CSAT Score-BU/Account/Portfolio level Process Compliance/Exceptions Scores Audit Coverage percentage Schedule performance Scores Planned vs actual project effort Resource productivity scores 2. Capability Building New Employee Onboarding New Employee Certifications 3. Continuous Improvement Lean projects implemented per year Productivity improvement of resources Continuous Improvement Processes implemented per year 4. Team Management Team attrition % Employee satisfaction scores 5. Capability Building % trained on domain and location specific skills, % of team trained in necessary leadership skills Mandatory Skills: SAP FS-CM Functional. Experience5-8 Years.

SkillSAP FI-FSCD LocationPune and Bangalore Minimum of 4 years SAP experience Configure G/L, A/P, A/R, Asset Accounting, Interface Integrations, Experience on Collections and Disbursements (FS-CD) Experience providing application support Relevant SAP certifications are a plus Do Ensure timely response of all the tickets raised by the client end user Service requests solutioning by maintaining quality parameters Act as a custodian of clients network/ server/ system/ storage/ platform/ infrastructure and other equipments to keep track of each of their proper functioning and upkeep Keep a check on the number of tickets raised (dial home/ email/ chat/ IMS), ensuring right solutioning as per the defined resolution timeframe Perform root cause analysis of the tickets raised and create an action plan to resolve the problem to ensure right client satisfaction Provide an acceptance and immediate resolution to the high priority tickets/ service Installing and configuring software/ hardware requirements based on service requests 100% adherence to timeliness as per the priority of each issue, to manage client expectations and ensure zero escalations Provide application/ user access as per client requirements and requests to ensure timely solutioning Track all the tickets from acceptance to resolution stage as per the resolution time defined by the customer Maintain timely backup of important data/ logs and management resources to ensure the solution is of acceptable quality to maintain client satisfaction Coordinate with on-site team for complex problem resolution and ensure timely client servicing Review the log which Chat BOTS gather and ensure all the service requests/ issues are resolved in a timely manner Deliver NoPerformance ParameterMeasure1.100% adherence to SLA/ timelines Multiple cases of red time Zero customer escalation Client appreciation emails Mandatory Skills: SAP FI Financial Supply Chain Management. Experience3-5 Years.

Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufacturing system. Experience of SOP preparation Preparation of inventory list, periodic review schedule, periodic review report Designation : Executive/Senior Executive Experience: 05 - 09 years

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7 to 10 years of experience Education Post Graduation in Microbiology or Biotechnology Competencies

About NxtWave NxtWave is one of India s fastest-growing Ed-Tech startups. NxtWave is revolutionizing the 21st-century job market by transforming youth into highly skilled tech professionals irrespective of their educational background with its CCBP 4.0 programs. NxtWave is founded by Rahul Attuluri (Ex Amazon, IIIT Hyderabad), Sashank Reddy (IIT Bombay) and Anupam Pedarla (IIT Kharagpur). The startup is backed by Orios Ventures, Better Capital and marquee angels, including founders of some of India s unicorns. NxtWave is an official partner for NSDC, under the Ministry of Skill Development & Entrepreneurship, Govt. of India, and recognized by NASSCOM, Ministry of Commerce and Industry, Govt. of India, and Startup India. The startup has received accolades as The Greatest Brand in Education in a research-based listing by URS Media, a leading international media house. By offering vernacular content and interactive learning, NxtWave is breaking the entry barrier for learning tech skills. Learning in their mother tongue helps learners achieve higher comprehension, deeper attention, longer retention, and greater outcomes. NxtWave now has paid subscribers from 450+ districts across India. In just 2 years, CCBP 4.0 learners have been hired by 1000+ companies including Google, Amazon, Nvidia, Goldman Sachs, Oracle, Deloitte, and more. Scale at which we operate on tech level (as on July 22) 50 Cr+ learning minutes spent 12 Cr+ Code Runs 2Bn.+ API Requests Handled by our servers Know more about NxtWave: https://www.ccbp.in Job Summary We are looking for a proactive and detail-oriented Associate Project Manager to support the smooth planning and execution of assessments across learner cohorts. The role involves coordinating assessment logistics, facilitating communication with stakeholders, handling student feedback processes, and supporting data accuracy and reporting. Key Responsibilities: Coordinate the creation and distribution of assessment links in alignment with internal timelines and academic plans. Maintain centralized records for assessment activities and ensure timely communication with relevant stakeholders. Review student feedback related to assessments and support the resolution of actionable concerns. Collaborate with internal teams to ensure assessments are approved, shared, and conducted in a structured and efficient manner. Facilitate the sharing of performance results and feedback summaries with learners. Support the setup and implementation of processes to address and act upon genuine feedback-related score updates. Preferred Skills & Qualifications: 1-2 years of experience in operations, academic support, or program coordination roles Strong communication, coordination, and documentation skills Familiarity with tools such as Google Workspace and basic project tracking systems Ability to work independently, manage multiple priorities, and adapt in a dynamic environment What We Offer Opportunity to impact the lives of learners and contribute to their success. Collaborative and dynamic work environment. Location: Hyderabad About NxtWaveNxtWave is one of India s fastest-growing Ed-Tech startups. NxtWave is revolutionizing the 21st-century job market by transforming youth into highly skilled tech professionals irrespectiv...

Experience in Vaccine/Injectable/Sterile manufacturing setup Review and evaluate facility, utility, process equipment & instrument design Prepare and review URS, DQ, FAT, SAT, IQ, OQ, PQ documents Conduct Computer System Validation (CSV) as per GAMP & 21 CFR Part 11 Coordinate with project teams to meet timelines and milestones Ensure compliance with GMP and regulatory standards Investigate deviations, failures, and non-conformances Identify root causes and implement CAPA Support audits and inspection readiness activities Job Location: Kadi, Gujarat ( Bus facility available from Ahmedabad, Kalol & Kadi) Note: Immediate joiners will be preferred first

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required) as and when needed. 6.0 To Identify and mitigate risks related to computerized systems at the site level. Prepare/support risk assessment documents and ensure execution of validation activities based on assessed risk. 7.0 Knowledge on computerized system inventory and GxP risk classification/ Impact Assessment. 8.0 Review and preparation of URS, FS, IQ, and OQ documents related to GxP computerized system, IS infrastructure and participate in qualification/validation or compliance verification of computerized systems. 9.0 Knowledge on Audit trail review. 10.0 Prepare/ review the computerized systems SOPs and ensure the site, GxP regulatory requirements. Preferred candidate profile

Job Description To have good knowledge about all microbiology testing. To initiate Change controls, deviations and CAPAs related to Microbiology. To prepare and review the Microbiology related documents SOPs /EOPs/ GTPs/STPs, Validation / Qualification / Re-qualification , QRM, URS etc. To monitor the Sample invert and online documents. To prepare and execute IQ/OQ/PQ of the new equipment installed. To prepare method validation protocol and report. To ensure online and accurate recording of all cGMP records at Microbiology section and to follow cGMP practices. To ensure the all-time readiness for Internal and External Audits. To ensure the timely completion of AMCs and PMs. Work Experience 7 to 10 years of experience. Education Post Graduation in Microbiology or Biotechnology Competencies

Walk-in Drive @ Bangalore on 22nd June 2025 (Sunday) Strides Pharma is hosting a Walk-In Drive for multiple roles. Venue: Strides Pharma Science Ltd. (R&D office): 165/2, 3rd Main Road, Oppo. Kalyani Magnum Tech Park, JP Nagar 4th Phase, Bengaluru-560076 Open Positions Department: Production Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Chennai Key Skills: Granulation, Compression, Coating, Capsule Filling, OSD Production Department: Packing Experience: 2-7 years Qualification: B.Pharm/M.Pharm Job Location: Bangalore Key Skills: OSD Packing, Bottle Packing, Blister Packing, BQS, CVC, BPR Department: Quality Control Experience: 2-7 years Qualification: B.Pharm/M.Pharm/M.Sc. Job Location: Bangalore Key Skills: Analysis of Raw Material, Finished products, In Process, Stability Samples, for Capsules & Tablets with expertise in HPLC. Department: Formulation Development Experience: 4-7 years Qualification: M.Pharm Job Location: Bangalore Key Skills: Planning & Execution of Lab scale experiments. DOE, Quality by Design, Product Development, Stability Protocol, Regulatory Market. Department: Engineering Process Maintenance Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Maintenance of RMG, FBD, Compression, Coating, Capsule filling, Blister Packing, Sachet Filling line, Bottle Packing Machines. Department: Engineering Projects & Utility Experience: 2-7 years Qualification: Diploma/B.Tech. (Electrical, Mechanical, Instrumentation) Job Location: Bangalore Key Skills: Installation, Commissioning, Equipment Qualification, DQ, IQ, OQ, PQ, Utility, Water System, HVAC, AHU, Chiller, Air Compressor, Cooling Tower, PLC, SCADA, HMI Best Regards, Talent Acquisition Team, STRIDES PHARMA SCIENCE LTD

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP Data Migration, Risk Asessment URS Preparation Good to have skills : NAMinimum 12 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that project goals are met, facilitating discussions to address challenges, and guiding the team in implementing effective solutions. You will also engage in strategic planning and decision-making processes, ensuring that the applications developed align with organizational objectives and user needs. Your role will require a balance of technical expertise and leadership skills to drive project success and foster a collaborative environment. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Expected to provide solutions to problems that apply across multiple teams.- Facilitate training and knowledge-sharing sessions to enhance team capabilities.- Monitor project progress and implement necessary adjustments to meet deadlines. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP Data Services Development.- Strong understanding of data integration and transformation processes.- Experience with ETL (Extract, Transform, Load) processes and tools.- Ability to troubleshoot and resolve technical issues efficiently.- Familiarity with database management systems and data modeling. Additional Information:- The candidate should have minimum 12 years of experience in SAP Data Services Development.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Job Title :Genesys_Level 7_Manager_(Entity -S&C GN) Management Level :Level 7 - Manager Location :Gurgaon, Mumbai, Bangalore, Chennai, Pune, Hyderabad Must have skills : Genesys Cloud, CX Transformation, CCaaS Advisory & Solution Architecture, CCaaS Consulting, Business Case Creation & Value Realization, Industry Solutions Consulting Good to have skills : Genesys PureConnect, Genesys Engage, Consulting experience across any of the CCaaS/Customer Service solutions (Amazon Connect, Nice, Verint, Cisco, Five9, Sprinklr, Twilio, Salesforce, Servicenow, Adobe, Microsoft Azure, Google Cloud etc.) Job Summary :Join our team of SONG consultants who solve customer-facing challenges at clients spanning sales, service, and marketing to accelerate business change. The Strategy & Consulting Global Network Song practice is aligned to the Capability Network Practice of Accenture and works with clients across their marketing, sales, and services functions. As part of the team, you will work on transformation services driven by key offerings like Marketing Transformation, Connected Commerce, and Advanced Customer Engagement. These services help our clients become living businesses by optimizing their marketing, sales, and customer service strategy, thereby driving cost reduction, revenue enhancement, customer satisfaction, and impacting front-end business metrics in a positive manner. Roles & Responsibilities : Develop and execute the contact center strategic initiatives including AI/Gen AI strategy to improve customer experience & optimize business expenses, operational costs. Create business case and strategic transformation roadmap based on market trends. Help sell and deliver Genesys contact center solutions to clients:Product overview, Partner readiness support, pricing, documentation, first call presentations. Drive Partner support activities:A strong focus on nurturing deeper, more strategic relationships with key parties. Develop requirements based on leadership input:Performance/Status reporting, Problem Solving and Conflict Management. Professional & Technical Skills : Experience working with Customer Service Operations:Experience in Contact Center channels, leading Customer Service operations assessment/benchmarking, identifying gaps and deriving business case for driving improvements. Experience implementing multichannel self-service/IVR and Omni-Channel Orchestration Routing:Experience in Genesys Cloud/Engage suite. In-depth knowledge and know-how of Customer Service Operations:Cross-industry experience, functional and hands-on experience on Voice and Non-Voice (SMS, Email, Chat etc.) applications solutioning using tools like Genesys Administrator & Architect/Composer/Designer. Proactively identifying customer needs through a technical benefits assessment:Carefully building the business value of the solution, to assist with overcoming potential objections to proposed technical solutions. Knowledge of on-premises, on-cloud, hybrid cloud and cloud economics:This includes pricing strategy of different Genesys on-premises and cloud solutions and providing detailed TCO. Experience in Genesys Cloud administration & application experience:Use Genesys Architect/Composer/Designer, Genesys Framework Components (such as Edge, BYOC, SIP, GAX, GVP, AppFoundry, eServices, GRE, URS, Info Mart, GMS, OCS, GPlus Integrations etc.) or similar solutions. Additional Information : An opportunity to work on transformative projects with key G2000 clients. Potential to co-create with leaders in strategy, industry experts, enterprise function practitioners, and business intelligence professionals to shape and recommend innovative solutions that leverage emerging technologies. Ability to embed responsible business into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your strategy & consulting acumen to grow your skills, industry knowledge, and capabilities. Opportunity to thrive in a culture that is committed to accelerating equality for all. Engage in boundaryless collaboration across the entire organization. About Accenture :Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology, and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions underpinned by the worlds largest delivery network Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 569,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. About Our Company | AccentureQualification Experience :8+ years Educational Qualification :MBA from a tier 1 institute

Job Title - (Genesys)+(Level 7-Manager)+(Entity -S&C GN) Management Level: 7-Manager Location: Gurgaon, Mumbai, Bangalore, Chennai, Pune, Hyderabad Must-have skills: Genesys, Genesys pure cloud, Genesys cloud Good to have skills: Genesys PureConnect, Genesys Engage, Consulting experience across any of the CCaaS/Customer Service solutions (Amazon Connect, Nice, Verint, Cisco, Five9, Sprinklr, Twilio, Salesforce, Servicenow, Adobe, Microsoft Azure, Google Cloud etc.) Job Summary : This role involves driving strategic initiatives, managing business transformations, and leveraging industry expertise to create value-driven solutions. Roles & Responsibilities: Develop and execute technology transformation strategies, oversee implementation projects, and optimize digital capabilities for business efficiency. You will work closely with our clients as consulting professionals who design, build and implement initiatives that can help enhance business performance. As part of these, you will Functional Experience :Develop and execute the contact center strategic initiatives including AI/Gen AI strategy to improve customer experience & optimize business expenses, operational costs Industry Experience Experience & Specialization in any of industry divisions such as Communication Media & Technology, Financial Services, Health & Public Services, Products & Resources. Understand market and customer challenges: Create business case and strategic transformation roadmap based on market trends. Help sell and deliver Genesys contact center solutions to clients: Product overview, Partner readiness support, pricing, documentation, first call presentations Drive Partner support activities: A strong focus on nurturing deeper, more strategic relationships with key parties Develop requirements based on leadership input: Performance/Status reporting, Problem Solving and Conflict Management Bring your best skills forward to excel at the role: Experience working with Customer Service Operations: Experience in Contact Center channels, leading Customer Service operations assessment/benchmarking, identifying gaps and deriving business case for driving improvements. Experience implementing multichannel self-service/IVR and Omni-Channel Orchestration Routing: Experience in Genesys Cloud/Engage suite. In-depth knowledge and know-how of Customer Service Operations: Cross-industry experience, functional and hands on experience on Voice and Non-Voice (SMS, Email, Chat etc.) applications solutioning using tools like Genesys Administrator & Architect/Composer/Designer. Proactively identifying customer needs through a technical benefits assessment: Carefully building the business value of the solution, to assist with overcoming potential objections to proposed technical solutions. Knowledge of on-premises, on-cloud, hybrid cloud and cloud economics: This includes pricing strategy of different Genesys on-premises and cloud solutions and providing detailed TCO Experience in Genesys Cloud administration & application experience: Use Genesys Architect/Composer/Designer, Genesys Framework Components (such as Edge, BYOC, SIP, GAX, GVP, AppFoundry, eServices, GRE, URS, Info Mart, GMS, OCS, GPlus Integrations etc.) or similar solutions. Professional & Technical Skills: - Relevant experience in the required domain. - Strong analytical, problem-solving, and communication skills. - Ability to work in a fast-paced, dynamic environment. Additional Information: - Opportunity to work on innovative projects. - Career growth and leadership exposure. About Our Company | Accenture Qualification Experience: 8+Years Educational Qualification: MBA from a tier 1 institute

Role & responsibilities Should have knowledge of SLD drawing Should be able to read the Electrical and Mechanical Drawing. Should be able to understand of P&ID and isometric Drawing. Basic knowledge of AutoCAD Hands on experience of Budget preparation of project work. Hands on experience on Project planning, handling and management. Should have able to manage material stock and record for consumption sheet preparation. Understand Companys Health & Safety Policy and follow all company HSE procedures. Should able to deliver the assigned task on time. Finalization of technical specification of machine Hands on experience on documentation like OQ,IQ,URS etc. Hands on experience of execution and commissioning of pharma machineries and utility Equipments Should have knowledge of HVAC system and clean room applications Should have knowledge of CGMP and revised schedule M Hand on experience of solid oral facility (Nutraceutical experience also be considered)Hands on Experience of WTP/utilities (Boiler, Chiller, WTP, Compressor, ETP, STP) piping, installation and commissioning. Hands on experience of vendor co ordination Should be able to present Project status/ reports and Daily work status/report. Manpower handling Hands on experience on Facility qualification, HVAC and Compressed Air Validation Provide technical input as required to ensure projects progress in line with their scope requirements. Support the development and completion of documentation in relation to purchasing, planning, implementation, commissioning and validation activities in relation to the above. Be responsible for Supervision of 3rd party contractors and internal service providers Be responsible for tracking and reporting project delivery, ensuring projects are delivered on time and within budget. Ensure training has been Given before undertaking specific duties and that all training is recorded in training records. Preferred candidate profile 5-7 years of hands-on experience in project engineering or project management roles within OSD pharmaceutical manufacturing . In-depth knowledge of OSD manufacturing processes , equipment, utilities, and facility layouts. Familiarity with HVAC , cleanroom classification, and GMP /cGMP requirements. Hands-on experience with equipment installation, commissioning, and qualification (IQ/OQ/PQ).

Job Description 1. Qualification of process equipment, area. HVAC and Utility qualification (Compressed air, Nitrogen and PSG) and equipment qualification like Vial washing, Tunnel, Filling, Sealing and Autoclave 2. CSV validation of different category of equipment. 3. Review of CSV documents like SIA, CFRA, RAP, RAR, VA, URS, DQ, FRS, 4. CS, IQ, OQ and Qualification of water system 5. calibration / qualification / requalification / cGMP compliance of equipment / instruments / measuring devices and area on periodical basis or as and when required.

Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, ICH Q9). Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents. Conduct impact assessments, risk assessments, and manage change control processes. Handle CAPA, incident management, and release management activities related to Validation activities. Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS. Utilize JIRA for tracking tasks, issues, and project progress. Collaborate with cross-functional teams to ensure successful Validation Documents preparation. Stay up-to-date with industry best practices and regulatory changes related to Validation. Qualifications 5+ years of proven experience in serialization implementation within the pharmaceutical industry. Strong understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9). Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM). Familiarity with quality management systems (QMS) and SOP development. Proficiency in using JIRA or similar project management tools. Excellent communication and interpersonal skills. Preferred Skills Experience with specific serialization software and hardware solutions (mention specific platforms if applicable). Knowledge of supply chain management principles. Certification in relevant areas (e.g., quality management, project management).

YOUR TASKS AND RESPONSIBILITIES: Preparation & Review of start-up Documents: eCRF completion Guidelines, DMP, SAE reconciliation plan, Clinical Coding Plan Preparation of Edit specification document (ESD), Test Plan and Data Entry Guideline Screen design UAT Edit checks UAT in CDMS as per ESD Discrepancy Management Support Data Manager in URS review for IWRS Ensure timely completion of SAE reconciliation activities Ensure timely completion of closeout activities including database lock Preparation and update of Master Data Management File to ensure its completeness Preparation & Review of Data Management Report WHO YOU ARE: Pharmacy / Science Post-Graduate At least 5 years of experience in the clinical data management domain in Pharma/CRO industry. Experience in, development of data management documents, development of validation plan, screen UAT, edit check UAT, clinical data query management etc. Job Location: Remote working job opportunity

Computer System Validation Analyst Experience: 3-6 years Location: Hyderabad(On-Site) Roles and Responsibilities: Develop and execute Validation strategies in line with client needs and regulatory guidelines (GxP, 21 CFR Part 11, GAMP 5, EU Annex 11) Create and maintain validation documentation, including Validation Plans, IQ/OQ/PQ protocols, URS, RTM, and other required documents Conduct impact assessments, risk assessments, and manage change control processes Handle CAPA, incident management, and release management activities related to Validation activities Develop and maintain in-house SOPs related to Validation processes and ensure adherence to QMS Utilise JIRA for tracking tasks, issues, and project progress Collaborate with cross-functional teams to ensure successful Validation Documents preparation Stay up-to-date with industry best practices and regulatory changes related to Validation Qualifications: 3+ years of proven experience in serialisation implementation within the pharmaceutical industry Strong understanding of regulatory requirements (GxP, 21 CFR Part 11, GAMP 5, ICH Q9) Experience with validation protocols (IQ, OQ, PQ) and documentation (URS, RTM) Familiarity with quality management systems (QMS) and SOP development Proficiency in using JIRA or similar project management tools Excellent communication and interpersonal skills Preferred Skills: Experience with specific serialisation software and hardware solutions (mention specific platforms if applicable) Knowledge of supply chain management principles Certification in relevant areas (e g-, quality management, project management) Show more Show less

Job Description Position: Application Engineer Full-time Location: Hyderabad We are looking for a self-motivated Application Engineer who can work alongside several specialists at our company. The Application Engineer will be part of our commercial team with dotted line to our multidisciplinary engineering team (Europe Based). To be successful as an Application Engineer, you should stay up to date with new drafting software (AutoCAD) and advancements. An exceptional Application Engineer will demonstrate impeccable attention to detail and have sound knowledge of the discipline they draft for. Responsibilities: Following specifications and calculations to create various technical drawings. Preparing both rough sketches and detailed work with CAD systems. Performing calculations for materials and weight limitations. Communicating with commercial colleagues and engineering team, and incorporating knowledge gained into drawings. Preparing, reviewing, and redrafting alongside the engineering team. Ensuring final designs are compliant with requirements. Identifying and communicating potential design problems to the rest of the team. Evaluating the User Requirement specifications and helping the commercial team to create an offer with designated item list as per the specifications of the User. Keep a tab on the entire project and help in communicating with the customer the various stages of the project, in co-ordination with the projects team from Italy to ensure smooth handover to customer care team prior to installation of the equipment. Requirements: Masters/ Bachelors degree in Engineering (Mechanical Engineering is a strong advantage) Proficient in computer-aided design and drafting software (CAD). Knowledge on salesforce will be an added advantage. Strong knowledge of MS Office Excellent communication and interpersonal skills Ability to work independently and collaboratively in a team environment. A strong technical background in the pharmaceutical industry is preferred. The job will be based in Hyderabad and the person should be a resident of Hyderabad. Willingness to travel within and outside the country as well. Must have a valid passport.

Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, youll play a key role in accelerating the delivery of medicines to the world. Your innovative ideas and proactive actions will help us imagine new possibilities and bring them to life, making a significant impact on global health. As an Associate in the Global Supply division, you will contribute to improving patients lives while working at Pfizer. Your dedication and expertise will ensure our plants, utility systems, buildings, and equipment are operational, helping us achieve new milestones and assist patients worldwide. What You Will Achieve In this role, you will: Support the Engineering team in planning and overseeing preventative maintenance for filling equipment. Manage the status of work control and backlog from work order submission to completion. Assist in maintenance work management and the installation, commissioning, and qualification of equipment. Contribute to continuous process improvement initiatives. Provide input on capital project design regarding equipment selection and specifications to minimize life cycle costs. Communicate schedules to all resources, including maintenance, production, outside services, stores, and engineering. Oversee pest control management in compliance with Good Manufacturing Practices (cGMP) and Pfizer internal requirements. Manage and properly archive all utility documents and drawings. Ensure the generation and maintenance of documentation supporting Good Manufacturing Practices (cGMP). Contribute to project tasks and milestones, organize work to meet deadlines, and apply basic team effectiveness skills within the immediate Work Team. Knowledge of commonly used equipment and machines in pharmaceutical industry Experience in control disciplines such as advanced process control (APC), distributed control systems (DCS), programmable logic controllers (PLC) and supervisory control and data acquisition (SCADA) Knowledge of qualification concepts - URS/DQ/IQ/OQ and PQ. Knowledge of commonly used equipment and machines in pharmaceutical industry Experience in control disciplines such as advanced process control (APC), distributed control systems (DCS), programmable logic controllers (PLC) and supervisory control and data acquisition (SCADA) Knowledge of qualification concepts - URS/DQ/IQ/OQ and PQ. Standard instruments Global calibration policies Knowledge on Clean room requirements and Regulatory Guidelines Documentation review skills Effective problem solving capabilities Excellent Interpersonal, written and communication skills Effective coordination between departments Preparation of Preventive Maintenance schedules. Execution of Preventive maintenance carried out as per the prepared and approved schedule Ensure that Instruments are connected as per the prescribed drawings while installing the equipment. Coordinate with both Internal and External resources for installation of various equipment. Preparation of SOP s and SOI s Attending breakdown maintenance and to ensure upkeep of the equipment Preparation and Review of respective Documents / Procedures Here Is What You Need (Minimum Requirements) Bachelors degree with any years of experience, or an Associates degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience Experience in reliability-based maintenance practices Demonstrated ability to write and provide simple and accurate instructions Aseptic manufacturing experience Demonstrated computer and technical skills Effective problem-solving capabilities Excellent interpersonal communication and written skills Bonus Points If You Have (Preferred Requirements) Knowledge or experience working in a Good Manufacturing Practices (also cGMP) environment Biopharma experience Strong organizational skills Ability to work independently and as part of a team Proactive and self-motivated Work Location Assignment: On Premise Engineering #LI-PFE

Role & responsibilities MAJOR ACCOUNTABILITY (Mention core tasks assigned to associate etc.) 1. Preparation of Qualification documents for Pharmaceutical HVAC system. - URS, DQ, IQ, OQ, PQ 2. Execution of HVAC modification projects 3. Review of HVAC assessment reports for modification scope of HVAC systems 4. Review of BOQ for HVAC modification 5. Preparation of URS for Air Handling Systems 6. Preparation of QRA & CR for HVAC modification projects 7. Review of HVAC layouts i.e. System zoning, Pressure Zoning, Area Classification drawings 8. Review of Heat Load calculations 9. Integration of new AHUs with BMS system & BMS system qualification 10. Creation of Maintenance plan, Calibration plan for the HVAC systems 11. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 12. Completion of all trainings assigned to role 13. Ensure integrity of data at workplace. 14. Ensure Good Documentation practices at workplace 15. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 16. Weekly meeting with cross functional team to meet project timeline. 17. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 18. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 19. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 20. Preparation of qualification document timely and Timely completion of project compliance action 21. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 22. Qualification documentation should prepare and execute with 100% accuracy without GXP error 23. All QMS actions should be completed within the assigned date. 24. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 25. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. Company : Sandoz Healthcare Location : Mumbai ( Kalwe ) Contract role and will be renewed yearly based share resumes to nedunuri.saikumar@manpower.co.in