152 Iq Jobs - Page 6

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Documentation practices at workplace 13. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 14. Weekly meeting with cross functional team to meet project timeline. 15. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 16. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 17. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 18. Preparation of qualification document timely and Timely completion of project compliance action 19. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 20. Qualification documentation should prepare and execute with 100% accuracy without GXP error 21. All QMS actions should be completed within the assigned date. 22. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 23. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. company : Sando z Location : Mumbai (Kalwe Sight) share resumes to nedunuri.saikumar@manpower.co.in

The candidate should be aware of Netapp storage structure. Which will cover the basics of Netapp. Must be aware of Cloning processes. Must be aware of Data protection & storage efficiency. Share your CV to ruban@futuresolution.co.in

Job Summary The ideal candidate will have a robust skill set particularly in Jenkins uDeploy GitHub actions Aws devops Nexus and Nexus IQ. Responsibilities The ideal candidate will have a robust skill set particularly in Jenkins uDeploy github actions Aws devops Nexus and Nexus IQ. The primary responsibilities will include managing and maintaining our continuous integration and continuous deployment (CI/CD) systems using Jenkins. They should be proficient in creating configuring and troubleshooting Jenkins pipelines to ensure smooth and efficient software delivery. Additionally experience with uDeploy is essential. The candidate will be responsible for automating and streamlining our application deployments ensuring that releases are executed seamlessly and without any hiccups. They should have a deep understanding of deployment strategies and the ability to manage complex deployment scenarios. Nexus skills are also crucial for this role. The candidate will be tasked with managing our artifact repository ensuring that all components are stored versioned and accessible as needed. They must be adept at configuring and maintaining Nexus repositories and troubleshooting any issues that may arise. Lastly knowledge of Nexus IQ is important. The candidate should be able to analyze and manage open-source components ensuring that all dependencies are secure and compliant with licensing requirements. They should have experience using Nexus IQ to identify and mitigate potential security risks in our software. This role requires a proactive individual with strong problem-solving skills and the ability to work collaboratively with various teams. They should possess excellent communication skills and be able to articulate complex technical concepts to both technical and non-technical stakeholders. Certifications Required Jenkins uDeploy GitHub actions Aws devops Nexus and Nexus IQ.

Role Description? This role involves working closely with Business Analyst Data architects, Data engineers, AI/ML engineers and Product Managers to ensure that Validation strategy and deliverables are produced for IT Systems. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise , validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to validation and meets our regulatory and validation procedures. This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated and validated . ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage Validation strategy and Deliverable for the GxP applications. Develop and manage test cases, protocols, and validation documentation within the Veeva VM Testing Vault. Execute test scripts to ensure system compliance with regulatory requirements and organizational standards. Identify , document, and track defects during the testing process. Collaborate with development teams to resolve defects and validate fixes. Ensure all testing and validation activities comply with GxP , FDA 21 CFR Part 11, and other regulatory standards. Maintain comprehensive audit trails and validation documentation to support regulatory inspections. Configure and optimize workflows within the VM Testing Vault to streamline test management and approval processes. Partner with quality assurance, IT, and business teams to ensure alignment on validation objectives and testing requirements. Act as a liaison between technical teams and stakeholders to ensure system requirements are met. Provide training to end-users on Veeva VM Testing Vault functionalities and best practices. Offer ongoing support to ensure effective use of the platform. Generate reports and dashboards to monitor testing progress, defect trends, and validation status. Basic Qualifications and Experience? Master’s degree and 1 to 3 years of Life Science/Biotechnology/Pharmacology/Information Systems experience? OR ? Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Pharmacology/Information Systems experience OR ? Diploma and 7 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience ? Functional Skills: ? Must-Have Skills: Solid understanding of GxP regulations, specifically 21 CFR Part 1 1 . Expertise in defining and executing validation strategies aligned with regulatory requirements. Experience in creati ng and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Familiarity with GxP Validation management tools such as ALM, Veeva Vault Management etc. ? Good-to-Have Skills: ? Proficiency in automation tools, data systems, and validation software (A pplication Lifecycle Management and/ or Veeva Vault Validation Managemen t) Experience of DevOps, Continuous Integration and Continuous Delivery methodology Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies ? Professional Certifications (please mention if the certification is preferred or mandatory for the role)? SAFe for Teams certification (preferred) ? Veeva VM certification (preferred) ? Soft Skills: ? Able to work under minimal supervision ? Skilled in providing oversight and mentoring team members. Demonstrated ability in effectively delegating work ? Excellent analytical and gap/fit assessment skills ? Strong verbal and written communication skills ? Ability to work effectively with global, virtual teams ? High degree of initiative and self-motivation ? Ability to manage multiple priorities successfully ? Team-oriented, with a focus on achieving team goals ? Strong presentation and public speaking skills ? ? Shift Information? This position operates on the second shift, from 2:00 PM to 10:00 PM IST. Candidates must be willing and able to work during these hours .

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 : Finastra Fusion Loan IQ Good to have skills : Java, Spring BootMinimum 7.5 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 day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. 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- Provide solutions to problems for their immediate team and across multiple teams- Lead the application development process effectively- Ensure seamless communication within the team and stakeholders Professional & Technical Skills: - Must have Skills :Finastra Fusion Loan IQ - Good to Have Skills :Spring Application Framework, Microservices and Light Weight Architecture - Integrate Loan IQ with Market data applications and clients proprietary software applications using Spring related frameworks - Perform Analysis, design, code, unit test and deployment in Loan IQ SDK, and ensure that interfaces are working fine - Develop and maintain batch report files from Loan IQ for Loan Operations, Treasury etc, - Assess the impact of changes on existing business and technology processes, as well as other interfacing systems Technical Experience :- 5+ years of sound experience in Loan IQ SDK, Loan IQ functionality, Java, Spring related frameworks Good to know Spring Boot and Microservices - Expertise in designing and developing the interface programs for different integrating applications Batch, Web Services, JMS etc, - Must have good Knowledge on Loan IQ Data Model - Good to have Interface Mapping documentation designing experience - At least, 1 RDBMS experience is required Oracle/MS-SQL/IBM DB2 - Good communication skills - Good analytical skills Additional Information:- The candidate should have a minimum of 7.5 years of experience in Finastra Fusion Loan IQ- This position is based at our Bengaluru office- A 15 years full-time education is required Qualification 15 years full time education

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 : Finastra Fusion Loan IQ Good to have skills : Java, Spring BootMinimum 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 day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. 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- Lead the application development process effectively- Ensure seamless communication within the team and stakeholders- Provide guidance and mentorship to team members Professional & Technical Skills: - Must have Skills :Finastra Fusion Loan IQ - Good to Have Skills :Spring Application Framework, Microservices and Light Weight Architecture - Integrate Loan IQ with Market data applications and clients proprietary software applications using Spring related frameworks - Perform Analysis, design, code, unit test and deployment in Loan IQ SDK, and ensure that interfaces are working fine - Develop and maintain batch report files from Loan IQ for Loan Operations, Treasury etc, - Assess the impact of changes on existing business and technology processes, as well as other interfacing systems Technical Experience :- 8+ years of sound experience in Loan IQ SDK, Loan IQ functionality, Java, Spring related frameworks Good to know Spring Boot and Microservices - Expertise in designing and developing the interface programs for different integrating applications Batch, Web Services, JMS etc, - Must have good Knowledge on Loan IQ Data Model - Good to have Interface Mapping documentation designing experience - At least, 1 RDBMS experience is required Oracle/MS-SQL/IBM DB2 - Good communication skills - Good analytical skills Additional Information:- The candidate should have a minimum of 12 years of experience in Finastra Fusion Loan IQ- This position is based at our Bengaluru office- A 15 years full-time education is required Qualification 15 years full time education

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 : Finastra Fusion Loan IQ Good to have skills : NAMinimum 7.5 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 day will involve overseeing the application development process and ensuring seamless communication within the team and stakeholders. 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- Provide solutions to problems for their immediate team and across multiple teams- Lead the application development process effectively- Ensure seamless communication within the team and stakeholders Professional & Technical Skills: - Must have Skills :Finastra Fusion Loan IQ - Good to Have Skills :Spring Application Framework, Microservices and Light Weight Architecture - Integrate Loan IQ with Market data applications and clients proprietary software applications using Spring related frameworks - Perform Analysis, design, code, unit test and deployment in Loan IQ SDK, and ensure that interfaces are working fine - Develop and maintain batch report files from Loan IQ for Loan Operations, Treasury etc, - Assess the impact of changes on existing business and technology processes, as well as other interfacing systems Technical Experience :- 5+ years of sound experience in Loan IQ SDK, Loan IQ functionality, Java, Spring related frameworks Good to know Spring Boot and Microservices - Expertise in designing and developing the interface programs for different integrating applications Batch, Web Services, JMS etc, - Must have good Knowledge on Loan IQ Data Model - Good to have Interface Mapping documentation designing experience - At least, 1 RDBMS experience is required Oracle/MS-SQL/IBM DB2 - Good communication skills - Good analytical skills Additional Information:- The candidate should have a minimum of 7.5 years of experience in Finastra Fusion Loan IQ- This position is based at our Bengaluru office- A 15 years full-time education is required Qualification 15 years full time education

The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process documentation: PFMEA, control plans, work instructions, SOPs, and batch records. Develop manufacturing strategies, assembly procedures, and pilot line setups for new product introductions (NPIs). Drive tooling, fixture design, and automation planning for scalable and cost-effective production. Support and lead design transfer activities from engineering to manufacturing, ensuring production readiness. Participate in clinical builds and first article inspections (FAI), ensuring traceability and documentation compliance. Use statistical methods to analyse process capabilities and implement continuous improvements. Lead root cause investigations for manufacturing issues and support CAPA implementation. Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Production teams to ensure product launch timelines are met. Provide input and support for regulatory submissions related to manufacturing process and V&V outcomes. Qualifications: Bachelors degree in mechanical, Manufacturing, or Industrial Engineering. 5+years of experience in medical device manufacturing, new product introduction (NPI), and process development. Strong knowledge of Verification & Validation (V&V) principles and experience with IQ/OQ/PQ protocols. Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820. Proficiency with CAD (e.g., SolidWorks), ERP systems (e.g., Odoo, SAP), and statistical tools (e.g., Minitab, JMP). Demonstrated ability to write and review technical documentation for audits and regulatory submissions. Preferred Skills: Experience in Class II/III medical device product launches. Exposure to cleanroom practices and ESD-safe assembly. Hands-on experience in FMEA, and process optimization.

Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing. Document test results and deviations. Software Testing as per requirements Internal/ external release. Compliance: Ensure systems comply with applicable regulations (FDA, EMA, GAMP 5). Participate in audits and inspections. Maintain audit trail and data integrity practices. Risk Assessment: Perform risk assessments and impact analyses for changes to validated systems. Change Management: Evaluate system changes and determine need for revalidation. Support Change Control processes. Collaboration: Work with QA, IT, engineering, and business units to support the validation lifecycle. Train users and system owners on compliance requirements. System Lifecycle Support: Manage validation activities through system development, implementation, maintenance, and decommissioning.

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 FI S/4HANA Accounting Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Person must be having good experience on SAP FI. Must be having good experience on CR, Writing FS etc.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 application requirements are met, overseeing the development process, and providing guidance to team members. You will also engage in problem-solving activities, ensuring that the applications align with business objectives and user needs, while maintaining a focus on quality and efficiency throughout the project lifecycle. 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.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate knowledge sharing sessions to enhance team capabilities.- Monitor project progress and ensure timely delivery of milestones. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP FI S/4HANA Accounting.- Strong understanding of financial accounting principles and practices.- Experience with integration of SAP modules and third-party applications.- Ability to analyze business requirements and translate them into technical specifications.- Familiarity with SAP reporting tools and data analysis techniques. Additional Information:- The candidate should have minimum 7.5 years of experience in SAP FI S/4HANA Accounting.- This position is based at our Bengaluru office.- A 15 years full time education is required. Qualification 15 years full time education

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done at time of IQ/OQ/PQ. Capable of making IQ/OQ and PQ protocols for Utility Systems. Coordinate between Project Manager & Utilities O&M for project work. Review pipelines & cables impacted by excavation work and align Utilities team. Should have experience in chiller operation and maintenance. Knowledge of other Utility areas like air compressors, vacuum pumps, RO system, water treatment plant. Provide troubleshooting of HVAC system, air compressor system and water treatment system. Conduct capability sessions through hands-on trainings and classroom sessions for PC&IS resources of Baddi & Bhiwadi. KPI deliverables Project Schedule deliverable As per the aligned timelines Leave planning – Needs to be aligned in advance and as per P&G standards with the manager. Final A on leave grant is the PM of P&G Quarterly performance reviews with PM Scope of contractor change in case not meeting aligned targets. Qualifications: Min Diploma in HVAC/Refrigeration/Mechanical/Piping system/Air Compressor System Experience: Min 5 years in HVAC operations, Air Compressor Systems and Water treatment Systems Have experience of project execution Basic electrical expertise Good communication skills – verbal & email Engagement duration Design work to Project SOP" Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pincode - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done at time of IQ/OQ/PQ. Capable of making IQ/OQ and PQ protocols for Utility Systems. Coordinate between Project Manager & Utilities O&M for project work. Review pipelines & cables impacted by excavation work and align Utilities team. Should have experience in chiller operation and maintenance. Knowledge of other Utility areas like air compressors, vacuum pumps, RO system, water treatment plant. Provide troubleshooting of HVAC system, air compressor system and water treatment system. Conduct capability sessions through hands-on trainings and classroom sessions for PC&IS resources of Baddi & Bhiwadi. KPI deliverables Project Schedule deliverable As per the aligned timelines Leave planning – Needs to be aligned in advance and as per P&G standards with the manager. Final A on leave grant is the PM of P&G Quarterly performance reviews with PM Scope of contractor change in case not meeting aligned targets. Qualifications: Min Diploma in HVAC/Refrigeration/Mechanical/Piping system/Air Compressor System Experience: Min 5 years in HVAC operations, Air Compressor Systems and Water treatment Systems Have experience of project execution Basic electrical expertise Good communication skills – verbal & email Engagement duration Design work to Project SOP" Warm Regards, ______________________________________ "Your Manpower Managers" Varun Shrivas Executive - TA | HR ASHKOM MEDIA INDIA PVT. LTD. (An ISO 9001:2015 Certified Company) "Ashkom House" Dk -2/6 , Danish Kunj, Kolar Road Bhopal Pincode - 462042 Madhya Pradesh Mobile : +91-6262600059 / 8989271488 Website: www.ashkom.com

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. 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 provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional 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 engagement within 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. Experience8-10 Years.

About The Role Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. ? 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 provide constructive feedback to own direct reports Guide the team members in acquiring relevant knowledge and develop their professional 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 engagement within 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. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. Can handle HVAC system operation and maintenance. Must have knowledge of RO membranes & EDI replacement and its troubleshooting. Must Have knowledge of SCADA system and cGMP documentation. Spare management, Vendor management, MIS reports etc. Do the planned work on time. e.g. PM, PR, PO's etc. To carry out upkeep round as per schedule and updating of the records. To follow the instructions relating to engineering operations and to ensure their strict implementation. Ensuring continuous improvements and engineering excellence. To follow good documentation practices. To ensure EHS procedures and practices are followed at site to achieve zero lost time accident and compliance. Responsible for documentation related to upkeep of water system and HVAC. Must have knowledge of RCA, FMEA, Change Control, deviation and other GxP documentation. You will be accountable for ensuring implementation of Good Engineering Practices (GEP) at Site. Qualification Educational qualification : A Diploma or a B.Tech in Mechanical or Electrical Engineering Minimum work experience : 5 to 8 years Skills & attributes: Technical Skills Responsible for documentation related to upkeep of water system and HVAC. Responsible of Operation oif water system and HVAC Managing contractors at site. Their Work permits etc. Water system Maintenance and upkeep of HVAC in proper manner. Spare management for water system and HVAC Spares Experience in managing RO Mem. and EDI maintenance plans. Ability to manage maintenance budget of an area/unit. Knowledge of GMP and GEP. Behavioural skills • Communication and collaboration skills to coordinate with cross functional teams, external contractors and agencies. • Attention to detail to ensure preventive maintenance, documentation, and inventory control. • Commitment to quality and compliance. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Role & responsibilities Utility Executive : 1. Responsible for Operation, Maintenance of Block Utilities & Central Utilities.. 2. Responsible for ordering, maintain stock of spares, consumables required for the machines & facility. 3. Responsible for implementation of Preventive Maintenance activities as per schedule. 4. Execution of Qualification documents. 5. Preparation of SOPs and reviewing of daily log sheets. 6. Responsible for Change Controls & Deviations. 7. Responsible for breakdown analysis &CAPA. 8. Responsible for Energy conservation in Utilities. 9. Responsible for up gradation in utility systems. 10. Responsible for minimising break downs & Improving efficiency of utility systems & equipments. Instrumentation Executive : 1.Responsible for Operation of Lyophilizers. 2. Responsible for Preventive Maintenance of Lyophilizers. 3. Responsible for history records & service cards. 4. Responsible for breakdowns of Lyophilizers. 5. Planning & execution of Anticancer block all lines instrumentation electronics activities. 6 .Execution of Qualification documents. 7. Packing hall machinery Instrumentation Preventive, Breakdown & Major activities maintenance 8. Responsible for Preventive maintenance and breakdown of utilities equipments. 9. Responsible for data backup activitys for computerized systems (Engineering scope). 10. Responsible for preparation and Execution of IQ, OQ & IOQ documents. 11. Responsible for preparation VMP Annexures.

Job Description Must Have: Experience in handling Clients and Stakeholder interactions. Well versed with CSV and GxP process and ability to adopt to client Process, systems and documentation needs like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Understanding of various SDLC methodologies(Agile, Waterfall, V) Flexibility to Work as per Customer timings Generate Automation Test Strategy for applications deployed on Cloud. ( Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest API, etc. Analyze requirements, perform impact analysis, and regression analysis, and communicate with stakeholders on the need for changes in requirements. Perform Risk Analysis of Project & automation deliverables and work towards mitigation plans. Good experience with various testing types like Functional, Regression, UI/ Usability, Integration testing, etc., Hands-on experience using ADO or any test management tools. Good to Have: Experience in Programming or scripting languages (Java/JS etc.,). Experience in designing automation frameworks (POM, Cucumber BDD, etc.,.). Experience working on CAPAS, Incident Management, FMEA Risk Assessment, Functional Risk Assessment etc., Experience with Vulnerability testing (VAPT). Knowledge of Performance testing using Jmeter or any open-source tools. Idea on Generative AI for testing. An idea of estimation techniques for Automation testing efforts (Design and Execution). Experience in testing and test planning of CI/CD-based solutions through tools like Azure DevOps. Role & responsibilities Preferred candidate profile

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standards. Facilitate the retrieval of technical documentation Collaborate with subject matter experts to review and validate technical documents Ensure that all technical documentation adheres to regulatory and quality standards.

What you will do Role Description: The Sr. Validation Engineer – Clinical Computation Platform will support the validation and operational management of clinical computation platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure clinical operations This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will collaborate with Product Managers and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. Roles & Responsibilities: Develop detailed test plans and strategies based on project requirements and specifications Perform manual and automated testing of software applications, including functional, regression, and performance testing Document and report defects and issues identified during testing, and work with development teams to resolve them Maintain detailed documentation of test/validation plans, test cases, and test results Validate that test scenarios meet feature acceptance criteria and customer expectations Maintain and ensure the quality of documented user stories/requirements in tools such as Jira Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment Prepare, execute, document, and report validation protocols in line with GxP’s and other regulatory requirements and standards Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Bachelor’s degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience Functional Skills: Must-Have Skills: Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology Experience with Agile software development methodologies (Scrum) Excellent communication skills and the ability to interface with senior leadership with confidence and clarity Experience with validation solutions, including compliance and data integrity. Good-to-Have Skills: Familiarity with cloud validation (AWS / Azure / GCP). Experience with validation solutions, including compliance and data integrity. Able to communicate technical or complex subject matters in business terms Jira Align experience Professional Certifications SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and troubleshooting skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. ? Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines. ? Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. ? Ensure timely and effective completion of all validation activities in line with project objectives and schedules. ? Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. ? Identify opportunities for process improvements in validation activities. ? Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies. ? Collaborate and communicate effectively with the product teams. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and teamwork skills Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contractual framework. As a visionary leader, you will inspire and guide our team of experts to deliver high-quality and reliable information technology services. Working closely with the latest systems, software products, and networked devices, you will align our solutions perfectly with our customers' evolving business needs. Your deep knowledge of the services we provide paired with your understanding of customer businesses, will enable you to propose and implement tailored solutions that exceed their expectations. You will be an integrated part of our customer account structure, fostering strong relationships with our customers and collaborating closely with our Delivery Partner & Customer Partner. Together, you will create an environment that promotes innovation, collaboration, and customer success. By owning the technical and managerial support for our plant IT team, field engineers, technicians, system administrators, subject matter experts, and product support personnel, you will empower them to deliver, manage, maintain, and deploy IT services effectively. When troubleshooting incidents, problems, changes, and escalations, you will be at the forefront, providing swift support to fix any issues that may arise in malfunctioning services, operations, software, or equipment. Your expertise will ensure that our systems run smoothly, offering our customers a seamless experience. As a plant operations Lead, you will have the unique opportunity to collaborate with an exceptional team of Delivery Partners, Architects, and SREs (Site Reliability Engineers). You will co-create, design, deploy, and maintain reliable, available, and future-proof systems and services. Your innovative ideas and leadership skills will play a vital role in shaping the technological landscape of our organization and the industry as a whole. If you are ready to make an impact, drive customer success, and be at the forefront of technological advancements, this is the role for you. Join our team and be part of an exhilarating journey as we reshape the IT services landscape with creativity, passion, and excellence. Your Future at Kyndryl Kyndryl has a global footprint, which means that as a Delivery Management Lead at Kyndryl you will have opportunities to work on projects and collaborate with colleagues from around the world. This role is dynamic and influential – offering a wide range of professional and personal growth opportunities that you won’t find anywhere else. Who You Are You’re good at what you do and possess the required experience to prove it. However, equally as important – you have a growth mindset; keen to drive your own personal and professional development. You are customer-focused – someone who prioritizes customer success in their work. And finally, you’re open and borderless – naturally inclusive in how you work with others. Required Skills and Experience Over 12 years of experience leading delivery teams and providing quality services to customers. Pervious experience in working with Pharma will be advantageous Strong understanding of Kyndryl competencies, managed platforms, IT services, and technology vendors. Strong understanding and knowledge of Pharam Plant IT Operations Oversee the day-to-day operations of IT infrastructure, network, applications, and support services. Ensure high availability and performance of critical systems including MES, LIMS, ERP, and SCADA. Ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11, GAMP 5, GxP). Collaborate with QA/Compliance teams to support audits and inspections. Maintain cybersecurity posture in line with corporate standards and industry best practices. Lead and mentor a team of IT professionals and support staff. Manage IT budgets, contracts, and vendor relationships. Work closely with cross-functional teams including manufacturing, QA/QC, engineering, and supply chain. Experienced in leading teams through incident, problem, and change management, as well as root cause analysis. Capable of partnering with Delivery Partners and collaborating with SREs to achieve positive customer outcomes. Hands-on knowledge of AIOps with an automation and innovation-focused mindset. Proficient in maintaining direct and ongoing interaction with customers. • Compassionate and empowering delivery resource manager, promoting growth Knowledge of IT/OT systems, industrial networking, and cybersecurity in manufacturing. Preferred Skills and Experience •Bachelor's degree •Six Sigma, PMP, and/or ITIL certifications Being You Diversity is a whole lot more than what we look like or where we come from, it’s how we think and who we are. We welcome people of all cultures, backgrounds, and experiences. But we’re not doing it single-handily: Our Kyndryl Inclusion Networks are only one of many ways we create a workplace where all Kyndryls can find and provide support and advice. This dedication to welcoming everyone into our company means that Kyndryl gives you – and everyone next to you – the ability to bring your whole self to work, individually and collectively, and support the activation of our equitable culture. That’s the Kyndryl Way. What You Can Expect With state-of-the-art resources and Fortune 100 clients, every day is an opportunity to innovate, build new capabilities, new relationships, new processes, and new value. Kyndryl cares about your well-being and prides itself on offering benefits that give you choice, reflect the diversity of our employees and support you and your family through the moments that matter – wherever you are in your life journey. Our employee learning programs give you access to the best learning in the industry to receive certifications, including Microsoft, Google, Amazon, Skillsoft, and many more. Through our company-wide volunteering and giving platform, you can donate, start fundraisers, volunteer, and search over 2 million non-profit organizations. At Kyndryl, we invest heavily in you, we want you to succeed so that together, we will all succeed. Get Referred! If you know someone that works at Kyndryl, when asked ‘How Did You Hear About Us’ during the application process, select ‘Employee Referral’ and enter your contact's Kyndryl email address.

Skill required.. •Accomplish ITQM objectives in the assigned project by planning, executing and evaluating quality activities (as per service description). Accountable that assigned projects implement security and compliance with applicable laws/regulations like CSV, NVS Standards, the IMF, and project methodology Hands-on experience in Regulatory Compliance (UK DPA, SOX, PII, Data Privacy & Security etc.). Should be able to liaison with the client information security, compliance & legal teams on regulatory requirements & facilitate evidence provisioning during audits • Experience in implementation of at least 2 complete cycles of Information Security Management Systems. Good understanding of domains such as Network security, Firewall audits, VA/PT, Access Management etc. Should have experience in domains such as ISAE3402 • Strong knowledge of Qualification and Validation project development/implementation processes. • Excellent FDA GxP understanding. • Knowledge of SoX, cGMPs, FDA and EMA guidelines. • Preferred Certifications: ISO 27000 LA, CISA, CISM, CISSP, ISO 9000 • Experience in planning & conducting & leading internal audits on information security, pharma quality & compliance • Experience in audits of ITSM processes (Change Mgmt, Incident/Problem Mgmt). ITIL V3 foundation must. • Good Program/Project management skills along analytics & reporting skills with strong communication & presentation. • Ability to work with all level of clients & internal resources • Knowledgeable about Business Continuity Management & Disaster Recovery. ISO 22301 experience preferred. JD • Point of contact for client stakeholders as well as HCL Operations team for guidance & support regarding compliance control requirements and implementation into service operations • Create & Document the control compliance plans for all services in scope • Lead Compliance processes for large Pharmaceutical Client for specific geography • Manages the infrastructure Qualification of hardware/Servers. • Maintains categorization of Off-the-shelf validation categories. • Ensure that the operations run-books & SOPs are inline & map with Policies, Standards, and Guidelines relating to security, privacy, and confidentiality for the Client IT Environment. Development of Security plan & ensuring adherence for all security domains relevant for in-scope services • Develop & Plan internal audit calendar aligned to clients internal as well as external audit schedule • Execute Security audits as per the agreed upon plan with client stakeholders and work with operations teams for remediation of any gaps and non-compliances • Provide agreed upon and ad-hoc reports for audits & compliance operations. • Facilitate in-time evidence provisioning to client audit, risk & compliance teams at time of external audits • Conduct process audits for ITSM as per agreed upon process controls • Participate in client meetings and committees that investigate compliance needs and develop new and modified Policies, Standards, and Guidelines We are looking for functional consultants have extensive experience in GxP related policies & process definitions and enforcements.