273 Csv Jobs - Page 11

Werum PAS-X Support Engineer Experience Level: 6-9 Onsite: Bangalore Roles & Responsibilities: System management/Support ITIL, System/Application management experience, CSV knowledge Skill Area: MES Background (Pas-X knowledge preferred) , ITIL, System/Application management experience, CSV knowledge Main Technology: MES/Pas-X Mandatory Skills: (Must Have Skills) Pas-X

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VALIDATION is MUST, preferably in Life Science . EXP in process optimization in automated test environment. GOOD knowledge in software development life cycle ( SDLC ). EXP in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guideline and FDA regulations on COMPUTER SYSTEM VALIDATION . Ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by ICH and FDA. Coordinating multiple validation and qualification activities with project teams, various departments and external vendors. System Testing, Regression testing; Backup and Restore; Disaster Recovery; Data Migration and upgrades introduced through change control. Conducting meetings for Risk Impact Assessments (RIA), Validation Risk Assessments and 21 CFR Part 11 Assessments. Creating User Requirements Specifications and assisting in the creation of a Functional Requirements Specification and the Technical Design Specification. Creating all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer. Reviewing all System Delivery Life Cycle (SDLC) deliverables, providing constructive feedback, and ensuring that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11 to client personnel. Representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules, conducting System Delivery Lifecyle (and Agile SDLC), Validation. Thanks & Regards YOGI GSN CONSULTING 9840074801 Email : yogi@gsnhr.net; Web : www.gsnhr.net/https://g.co/kgs/UAsF9W

We are seeking an experienced professional for the role of Assistant Manager, Computer System Validation (CSV) to join our Risk Advisory team. The ideal candidate will have a strong background in computer system validation within the life sciences and pharmaceutical industry, with a deep understanding of regulatory requirements and validation methodologies. Job Description- Computer System Validation (Assistant Manager) At least 6-7 years of computer system validation experience in a Life sciences and pharmaceutical environment. Good knowledge of cGxP regulations and software lifecycle approaches (e.g., 21 CFR part 11, EU Annex 11, GAMP 5, SDLC Waterfall/Agile methodologies) Having knowledge on Computer system Assurance (CSA) Experience in the validation of software and tools in a FDA regulated environment. (e.g, SAP, Solution Manager, EDMS, LIMS, PLC/SCADA systems etc.) Good to have experience on infrastructure qualification documentation- QP, IS, IQ, RTM Basic understanding of cyber security, Public Cloud Platforms such as AWS, Azure, IT Network components is a plus point. Experience of authoring and reviewing validation documentation and SOPs to maintain compliance Ensure documentation and practices meet quality standards, applicable regulatory compliance and company guidelines/policies as per cGxP Experience in risk assessment during the implementation and operation of IT solutions. Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, documentation, and SOPs. Review the accuracy and completeness of software validation deliverables created by other process teams CSV deliverables like of Gap Analysis, Remediation Plan, Change Control Management, Risk Assessment and validation documentation like SOPs, Validation Plan, User Requirements Specification, Qualification Plans, Validation Summary Report, Traceability Matrix, IQ/OQ/PQ Test Protocols for accuracy, consistency, clarity, and completeness Understand Deviation, how to perform its investigation and propose CAPA for the deviation. Handled change management and aware of writing change requests. Experienced in working with validation tools such as HP ALM/Validator/Valgenesis Ability to lead projects end-to-end, including stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. Manage multiple concurrent tasks and be flexible. Experience in facing internal quality audits, vendor audits and also providing support during audits by external auditors like US FDA in validation perspective. Mandatory Skills 21 CFR part 11, EU Annex 11, GAMP MS Office Suite- Word, Excel, PowerPoint Good verbal, and written communication skills in English Good to have Knowledge of 21 CFR Part 210, 211, 820, EU MDR, SOX, CSA Certifications such as ISO 27001, Cloud certification, Testing ISTQB, TMMi Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.

Hi, We are having an opening for R&D-IT Manager-ELN at our Baroda location. Job Summary : R&D-IT Manager will be responsible for the successful implementation of assigned projects. This role requires a strong technical skills and deep compliance understanding of R&D and Lab procedures and processes and the ability to work closely with cross-functional teams to ensure IT applications are running successfully. Experience in ELN implementation is preferred. Role and Responsibilities : ELN implementation for R&D Functions NuGenesis SDMS platform upgrade implementation Implementation of PMS- Store Inventory & Equipment inventory Computer System Validation of scientific software and instrument software Managing and closure of assigned QMS within the timelines Application support for Regulatory information management project Implementation support, testing and documentation of ongoing projects at R&D Baroda site Responsible to face internal/external audits and draft audit response, as needed Qualifications and Preference Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 5-7 years of experience in application support, preferably Pharma/ life sciences domain Ability to manage multiple tasks and projects simultaneously. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Preferred Qualifications Familiarity with laboratory instruments and software ELN implementation experience Good documentation skills to create and manage GxP documents Project Management skills

Hi, We are having an opening for Executive/Sr. Executive- R&D IT at our Gurgaon location Job Summary : R&D-IT Executive/Sr. Executive will be responsible for supporting IT applications, managing QMS across R&D Gurgaon functions. The person should have a strong understanding of CSV. The role requires a good understanding and experience in R&D/Lab policies and procedures to ensure applications/QMS are comply as per the applicable regulation. Job Description : Role and Responsibilities Application support for R&D applications (PMS, NuGenesis, Empower, Amplexor etc.) Managing and closure of assigned QMS within the timelines Application implementation support, testing and documentation of ongoing assigned projects Helping and providing IT support to business users during Performance Qualification phase Perform miscellaneous job-related duties as assigned Qualifications Bachelor's degree in Information Technology, or Computer Science or related field. Minimum of 3-5 years of experience in application support, preferably Pharma/ life sciences domain Strong understanding of CSV Software Development Life Cycle Preferred Qualifications Experience in NuGenesis and Empower is preferred Good documentation skills to create and manage GxP documents

Role & responsibilities Job Title: Sr. eCompliance Specialist/Manager Education (minimum/desirable): Degree in Life Sciences, Pharmacy, Engineering, or Information Technology; or similar; advanced degree preferred. Languages: Fluency in English (oral and written), additional language(s) a plus. Experience/Professional requirement: 5-10 years of overall experience, and a minimum 5 years of relevant experience in the Pharmaceutical Industry and in particular within regulated functions such as IT Quality and Compliance; CSV compliance. Profound understanding of global regulations and Health Authorities expectations governing computerized systems incl. computerized systems validation, lifecycle management and 21 CFR Par 11 requirements, EMA Annex 11. Experience in the development, implementation, and lifecycle management of computerized systems in regulated environments Experience in quality management of onsite, Cloud, SaaS platform, mobile and digital application used in regulated environments Highly experienced in the operational management of GxP solutions including its related technologies to support the operation. Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.) Experience in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space (e.g. ERP/SAP, MES, Trackwise, CRM, IAM, etc.) Experience in ensuring the compliance of GxP application validation and Infrastructure Qualification Successful cross-divisional/functional work with complex international teams Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude Proven ability to influence without hierarchical authority and build trusted partnerships Proven self-starter with experience in initiating and delivering projects and processes Excellent communication, interpersonal skills, and critical thinking COMPANY : SANDOZ LOCATION : HYDERABAD CONTRACT FOR 6 MONTHS WILL BE RENEWED ON PERFORMNCE SHARE RESUMES TO NEDUNURI.SAIKUMAR@MANPOWER.CO.IN

Company Description Welcome to AmpleLogic! We're a trusted provider of GAMP solutions, specializing in empowering the life sciences industry through our advanced Application Platform as a Service (aPaaS) platform. We are seeking a highly skilled and detail-oriented Quality Assurance (QA) Specialist with extensive experience in Computer System Validation (CSV) to join our team. This role will focus on ensuring the highest level of compliance, quality, and performance for all software and systems used within our organization, especially those that are regulated under industry standards. The ideal candidate will have a deep understanding of CSV processes, as well as experience working in highly regulated environments like pharmaceuticals, healthcare, or manufacturing. Oversee and execute Computer System Validation (CSV) for software and hardware systems, ensuring compliance with GxP, 21 CFR Part 11, FDA guidelines, and industry standards. Develop, review, and approve essential validation documents such as Validation Plans, URS, FRS, DS, and other relevant documentation. Create, execute, and document IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) test protocols to ensure systems meet required specifications. Ensure all validation processes align with regulatory requirements and industry best practices, maintaining up-to-date software compliance. Assist in both internal and external audits, regulatory inspections, and assessments, ensuring systems meet all compliance and quality standards. Perform risk assessments to determine validation needs and ensure thorough coverage during validation activities. Participate in change control processes to ensure validated systems remain compliant following updates or changes. Work with IT, Development, and Regulatory teams to ensure project requirements are met and provide internal training on CSV and SDLC practices. Monitor the quality of the final product, ensure compliance, control code release mechanisms, and manage action items from exited employees. Review processes, suggest improvements, maintain project documentation, perform audits, and handle LMS and software support tasks efficiently.

locationsIN - Bangalore posted onPosted 10 Days Ago time left to applyEnd DateMay 30, 2025 (13 days left to apply) job requisition idR139071 A.P. Moller - Maersk is an integrated container logistics company and member of the A.P. MollerGroup. Connecting and simplifying trade to help our customers grow and thrive. With a dedicatedteam of over 80,000, operating in 130 countries; we go all the way to enable global trade for a growingworld. From the farm to your refrigerator, or the factory to your wardrobe, A.P. Moller - Maersk isdeveloping solutions that meet customer needs from one end of the supply chain to the other. Team / Opportunity At Maersk, we are transforming to become the global integrator of container logistics- connecting and simplifying our customers supply chains. The Technology Group is critical to realising the company strategy. We plan on significantly enhancing our Technology capabilities and are implementing a new technology architecture led through Platform Operating Model. The Cloud Engineering Unit within the Technology Group is accountable for end to end delivery of Service Reliability, Availability, Performance, Cost and Fit for Purpose solutions there by enabling the Platform Operating Model. Who we are looking for 5+ years of Cargowise support engineer's responsibilities include: Bachelors/masters degree in computer science, Information Technology, or Engineering Providing second and third line support to users of the CW1 service desk Investigating support service level deviations and performing proactive troubleshooting Leading CW1 deployments and in-country engagements, including new country implementations Troubleshooting existing customizations workflow, tag rules files received via eAdaptor Demonstratable technical knowledge and expertise of CargoWise Cargowise One Workflow Design and understanding the use of event code, milestones, tasks and trigger and macro setup in filtering Experience using, configuring, and troubleshooting modules such as Registry, EDI Message, Tag Rules, Workflow Templates, and Buffer Management System Proficiency in handling data formats such as XML, JSON, EDIFACT, X12, raw text files, EXCEL, CSV, and tagged separated files XUE and XUS analysis and understanding of EDI communications setup with carriers, airlines and message analysis Experience in SNOW and handling of tickets before (preferred but not required) Producing comprehensive supporting documentation Collaborating with onshore and offshore teams to ensure quality transitions and develop functional specifications Proactively learning and sharing upcoming CW1 features Identifying continuous improvement opportunities Maersk is committed to a diverse and inclusive workplace, and we embrace different styles of thinking. Maersk is an equal opportunities employer and welcomes applicants without regard to race, colour, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, pregnancy or parental leave, veteran status, gender identity, genetic information, or any other characteristic protected by applicable law. We will consider qualified applicants with criminal histories in a manner consistent with all legal requirements. We are happy to support your need for any adjustments during the application and hiring process. If you need special assistance or an accommodation to use our website, apply for a position, or to perform a job, please contact us by emailing .

Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

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/#!/

We at Smart Infrastructure Division in Siemens Ltd. is one of the top tier global suppliers of products, systems, solutions, and services for the efficient, reliable, and intelligent transmission and distribution of electrical power. As the trusted partner for the development and extension of an efficient and reliable power infrastructure that industry and the portfolio they need. JOIN US! WE MAKE REAL WHAT MATTERS. THIS IS YOUR ROLE. System Designing and Application Engineering for MV AIS panels (Domestic + Exports). Main responsibilities: Technical review of order inputs received from sales Creation complete engineering drawings including GA, SLD, schematic drawings etc Getting drawing approval from customer including attending customers / consultant meetings for approval. Co-ordinating with order manger, DTO (mechanical design team), logistics, drafting vendor etc. Candidate should possess: Good knowledge about Medium voltage power distribution system and AIS panels Knowledge of IS/IEC standards applicable for MV systems Hands on Experience/knowledge in AutoCADD, ELCAD, Promis, E Base tools Knowledge of Protection Philosophy Expert in control philosophy of substation Good Communication skill Capable to interact independently with client for technical discussions Experience in handling major Engineering consultant like EIL, TCE, AECOM, Toyo, Mecon, Fitchtner, TKIS etc Education: B.E. / Diploma in Electrical Engineering with minimum 4 to 5 Years of Experience WE"™VE GOT QUITE A LOT TO OFFER, HOW ABOUT YOU? We"™re Siemens. A collection of over 379,000 minds building the future, one day at a time in over 200 countries. We're dedicated to equality, and we encourage applications that reflect the diversity of the communities we work in. All employment decisions at Siemens are based on qualifications, merit, and business need. Bring your curiosity and creativity and help us shape tomorrow.

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.

All Levels Comms & Media Non-Networks Join our team in Strategy consulting to find endless opportunities and solve our clients toughest challenges, as you work with exceptional people, the latest tech and leading companies across industries. Practice: Comms & Media, Industry Consulting, S&C Global Network (GN) I Areas of Work: Non-Networks | Level: Manager & Sr Manager | Location: Delhi, Gurgaon, Mumbai, Bangalore, Pune, Hyderabad | Years of Exp: 8- 15 years Explore an Exciting Career at Accenture Are you an outcome-oriented problem solver? Do you enjoy working on transformation strategies for global clients? Does working in an inclusive and collaborative environment spark your interest? Then, is the right place for you to explore limitless possibilities. Comms & Media (C&M) is one of the Industry Practices within Accenture's S&C Global Network (GN) team. It focuses in serving clients across specific Industries Communications, Media & Entertainment. Communications Focuses primarily on industries related with telecommunications and information & communication technology (ICT). This dynamic team serves most of the world's leading wireline, wireless, cable and satellite communications and service providers. Media & Entertainment Focuses on industries like broadcast, entertainment, print and publishing.Globally, works to develop value growth strategies for its clients, who are top-notch organizations, and help improve their offers and go-to-market performance and maximize organizational effectiveness. We work on end-to-end projects delivering management and technology consultancy to help our clients achieve greater profitability, quality, and reliability.From multi-year major systems integration transformation deals to shorter more agile engagements, we have a rapidly expanding portfolio of hyper-growth clients and an increasing footprint with next-gen technology and industry practices, with the following requirements: Deep expertise in one or more Telecom Domains Lead delivery of small to medium-size teams to deliver management consulting projects for global clients. Lead innovation transformation programs and process enablement for our clients Take responsibility within Comms & Media industry group or across the Products group, help build the practice, track metrics, and so on. Develop assets and methodologies , point-of-view, research, or white papers for use by the team and larger community. Support global sales team to identify and win potential opportunities within the practice. Help in drafting proposals as an expert for domain areas. Lead proposals, business development efforts and coordinate with other colleagues to create consensus-driven deliverables. Understand customer needs and translate them to business requirements, business process flows and functional requirements Experience to engage with stakeholders independently Execute a transformational change plan aligned with client's business strategy and context for change. Engage stakeholders in the change journey and build commitment for change. Bring your best skills forward to excel in the role: Skills in one or more Telecom areas Should have an excellent knowledge on various BSS modules and Telco Journeys such as CRM, Order Management, Billing, Mediation, Provisioning, Collections, Channels, Customer Care, Lead to Cash etc. Digital Transformation - Proven experience in Strategy, Innovation and Digital initiatives across Digital Maturity models, CSPs Operating model, Innovation Barometers, Intelligent operations for CSPs and other related areas Cloud BSS - Determine the appropriate Cloud deployment model & design BSS journey to cloud strategies engineered to accelerate ROI and performance. Good to have knowledge of tools like AWS, Azure, SFDC, etc. Business Strategy - Leading/managing strategic initiatives and develop project plans, frame and conduct insightful analyses, identify solutions, and develop business cases and implementation plans for CSPs across the globe Transformation & Project Governance - Drive profitability and continued success though managing service quality, cost and leadership of the people delivering services across projects/ programs/portfolios of all scale Should have understanding of lean concepts and hands-on experience in delivering technology-driven business transformation projects using agile practices such as Scrum, Kanban, SAFe, etc. Experience in agile related tools like JIRA Confluence/Rally/MS Projects/VersionOne Certification profession in PSM/CSM/SAFe/ICP-ACC Skills in one or more roles Experience in the role of Functional Business Analyst, Product Owners, Process Designers, Service Designers, Scrum Masters, Program Delivery Managers Business Analysis - Gather requirements from business and prepared requirement documents. Propose solutions to the client based on gap analysis for the existing Telco platforms. Analyse large data to conduct analysis and present insights with visualisations Process Improvement - Understand issues with the current processes which can be resolved either through technology or process solutions and design detail level to-be process with all stakeholders Value Architect and Tracking - Create value driver trees to breakdown into value components of business objectives and value drivers Other required skills Communication and Presentation - Plan and deliver well-structured oral and written communications Structured Problem Solving - Help identify and structure key client challenges into hypotheses and conduct analyses to address the challenges Stakeholder Management - Manage mid-level to senior client leadership and lead conversations Impeccable team management skills with an ability to engage effectively with multiple stakeholders Strong program management skills Cross-cultural competence with an ability to thrive in a dynamic environment Qualifications Your experience counts! MBA from a Tier 1 and Tier 2 school and Engineering from Tier 1 school or rich relevant industry experience At least 1-15 years of progressive business and/or telecom and consulting experience Knowledge of Telco BSS/OSS stack, its various components, and interactions / flows Strong telecom industry background experience and knowledge of BSS processes for B2C and B2B areas Knowledge of telecom products across wireline, wireless and Enterprise domains eTOM certification is highly desirable Direct onsite experience (i.e., experience of facing client inside client offices in India or abroad) is mandatory. Please note we are looking for client facing soft skills Experience in strategy and business/technology consulting role conversant with process improvement, cost optimization, customer analytics and experience management, telecom technology etc. Experience in value architecting, business case preparation, value realization Experience in Digital, New IT, Cloud & Core modernization, Cloud transformation processes, transforming legacy to the cloud, Agile transformation, RPA, AI/ML strategy implementation and use cases Knowledge of design thinking workshops and innovation Experience in large data analysis, data driven consulting, BI and analytics, reporting, dashboarding, visualization tools like PowerBI, Tableau Certifications like CBAP, CSM, SPC, Prince 2 or PMP will be an added advantage For Experienced candidates, experience of team Management Coach and mentor team members in projects, on asset development, BDs and overall professional development Whats in it for you? An opportunity to work on with key G2000 clients Potential to 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 into everythingfrom how you service your clients to how you operate as a responsible professional. Personalized training modules to develop your to grow your skills, industry knowledge and capabilities Opportunity to thrive in a that is committed to accelerate 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. Visit us at About Accenture Strategy & Consulting: Accenture Strategy shapes our clients future, combining deep business insight with the understanding of how technology will impact industry and business models. Our focus on issues such as digital disruption, redefining competitiveness, operating and business models as well as the workforce of the future helps our clients find future value and growth in a digital world. Today, digital is changing the way organizations engage with their employees, business partners, customers, and communities. This is our unique differentiator. To bring this global perspective to our clients, Accenture Strategy's services include those provided by our S&C Global Network (GN) a distributed management consulting organization that provides management consulting and strategy expertise across the client lifecycle. Our S&C Global Network (GN) teams complement our in-country teams to deliver cutting-edge expertise and measurable value to clients all around the world.For more information visit At the heart of every great change is a great human. If you have ideas, ingenuity and a passion for making a difference, .

Dear Candidate, We are hiring a Scala Developer to work on high-performance distributed systems, leveraging the power of functional and object-oriented paradigms. This role is perfect for engineers passionate about clean code, concurrency, and big data pipelines. Key Responsibilities: Build scalable backend services using Scala and the Play or Akka frameworks . Write concurrent and reactive code for high-throughput applications . Integrate with Kafka, Spark, or Hadoop for data processing. Ensure code quality through unit tests and property-based testing . Work with microservices, APIs, and cloud-native deployments. Required Skills & Qualifications: Proficient in Scala , with a strong grasp of functional programming Experience with Akka, Play, or Cats Familiarity with Big Data tools and RESTful API development Bonus: Experience with ZIO, Monix, or Slick Soft Skills: Strong troubleshooting and problem-solving skills. Ability to work independently and in a team. Excellent communication and documentation skills. Note: If interested, please share your updated resume and preferred time for a discussion. If shortlisted, our HR team will contact you. Kandi Srinivasa Reddy Delivery Manager Integra Technologies

Position Summary As a Lead / Architect, you will define and implement cutting-edge UI architectures, frameworks, and best practices to enhance user experiences. Youll collaborate with designers and developers to create intuitive, high-performance web and mobile applications that set new standards in usability and innovation Education BE/B.Tech Master of Computer Application Work Experience Work Experience About 7 to 10 years of Experience in UI application architecture, design and implementation. UI Application Architect with full stack capability for Architecture, Design and Implementation of interactive UI Applications for Data entry, CRUD operations, Approval Workflows, Notification and Alerts, basic reports/dashboards. Strong experience in building UI application with front end application as Angular or React or similar JavaScript based tool and back end application with Python, Flask or Fast API. Experience in end to end Design, development, System & Integration testing and production deployment. Experience in working with testing tools, version control, release management and automation. Experience in working with AWS or Azure Cloud platform, leading RDBMS databases, File Structures like JSON, XML, CSV. Experience in building Application Security with framework for Authentication and Authorization, Data encryption and Security standards and best practices. Knowledge of data modeling concepts and practices for UI Applications Behavioural Competencies Teamwork & Leadership Motivation to Learn and Grow Ownership Cultural Fit Talent Management Technical Competencies Problem Solving Lifescience Knowledge Communication Project Management Attention to P&L Impact Capability Building / Thought Leadership Scale of revenues managed / delivered

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.

Only MALE Candidate Exp in 21 CFR Part 11 / Annexure 11, CSV,GAMP 5, Data Integrity requirements for Pharma Experience of working at Pharma Site QC,QA,IT,CSV etc •Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report). Experience in any other validations (cleaning, process, etc.), temperature mapping etc. would be a plus: Excellent communication skills. Ability to work as a team player in a consulting environment. Proficiency with MS Office tools. Documentation management Strong Project Management experience (preferred but not required)

Minimum 5+ years of extensive RPG and SQL Experience. Responsibilities Design and implement enterprise solutions based on business needs. Collaborating with IT stakeholders to define requirements and ensure secure cost-effective architectures. Required Candidate profile Lead or support project teams, guide technical decisions, and maintain current knowledge of technologies, standards, and compliance (e.g., PCI).

The Data Integration Engineer will play a key role in designing, building, and maintaining data integrations between core business systems such as Salesforce and SAP and our enterprise data warehouse on Snowflake. This position is ideal for an early-career professional (1 to 4 years of experience) eager to contribute to transformative data integration initiatives and learn in a collaborative, fast-paced environment. Duties Responsibilities: Collaborate with cross-functional teams to understand business requirements and translate them into data integration solutions. Develop and maintain ETL/ELT pipelines using modern tools like Informatica IDMC to connect source systems to Snowflake. Ensure data accuracy, consistency, and security in all integration workflows. Monitor, troubleshoot, and optimize data integration processes to meet performance and scalability goals. Support ongoing integration projects, including Salesforce and SAP data pipelines, while adhering to best practices in data governance. Document integration designs, workflows, and operational processes for effective knowledge sharing. Assist in implementing and improving data quality controls at the start of processes to ensure reliable outcomes. Stay informed about the latest developments in integration technologies and contribute to team learning and improvement. Qualifications: Required Skills and Experience: 5+ years of hands-on experience in data integration, ETL/ELT development, or data engineering. Proficiency in SQL and experience working with relational databases such as Snowflake, PostgreSQL, or SQL Server. Familiarity with data integration tools such as FiveTran, Informatica Intelligent Data Management Cloud (IDMC), or similar platforms. Basic understanding of cloud platforms like AWS, Azure, or GCP. Experience working with structured and unstructured data in varying formats (e.g., JSON, XML, CSV). Strong problem-solving skills and the ability to troubleshoot data integration issues effectively. Excellent verbal and written communication skills, with the ability to document technical solutions clearly. Preferred Skills and Experience: Exposure to integrating business systems such as Salesforce or SAP into data platforms. Knowledge of data warehousing concepts and hands-on experience with Snowflake. Familiarity with APIs, event-driven pipelines, and automation workflows. Understanding of data governance principles and data quality best practices. Education: Bachelors degree in Computer Science, Data Engineering, or a related field, or equivalent practical experience.

Key Information: Location: Coimbatore Workplace type: Full time, in-office position Experience level: 8 - 10 years Key Skills: Java 17, Spring MVC, Restful services, React, AWS Relocation Assistance- Yes Other skills: Team Leading experience About Freespace (afreespace.com): Were a workplace technology company helping organizations to achieve three key outcomes: Right size, right design: Enabling informed decisions using real-time data to achieve portfolio optimization and the right workplace design Smart building automations: Streamlining processes by simplifying complex seating requirements and through occupancy-driven control and automation Exceptional employee experiences: Maximizing the benefits of the office by providing employees with the tools to find and reserve spaces, connect with each other and enjoy optimal working conditions To achieve these outcomes, we provide an integrated platform that delivers actionable workplace intelligence, through a real-time analytics platform, workplace sensors, employee experience app, signage and space management solutions. We have recently been recognized with a nomination for the IFMA New York Awards of Excellence in the Sustainability category, underscoring their achievements in fostering adaptive, efficient, and sustainable work environments. About Role: An expert backend engineer with proficiency in Java and Spring An active team member, having ownership & accountability to develop mobile app backend, in delivering timely projects through Scrum You enjoy defining simple and consistent APIs that consumers enjoy working with You thrive on taking technical ownership of large systems On a day-to-day basis, you will: Work with the product team and other team leads to clarify requirements, challenge assumptions to ensure successful executions, and push the user app functionalities to their best Largely hands-on with coding; at the same time, you are the mentor for your team who helps them break complex problems into more manageable tasks that can be easily estimated Design business-critical microservices Collaborate in defining the overall cloud architecture Develop RESTful APIs with Spring Boot Create database schemas that represent and support business processes. Perform user authentication and authorization between multiple systems, servers, and environments. Design and develop end to end working pipeline from hardware to the visual representation layer. Data migration, transformation, and scripting. Outputting data in different formats such as XML, JSON, CSV, etc. Implementing automated testing platforms and unit test tools. Required skills & experience: Strong expertise in Java and Spring MVC. Proficient understanding of OWASP security principles. Proficient understanding of code versioning. A good understanding of front-end technologies and platforms, such as JavaScript, HTML5, and CSS3, and knowledge of react will be a plus. Experience with SQL-style querying language. Experience with WebSocket, HTTP, and similar communication protocols. Understanding of “session management” in a distributed server environment. Exposure to Git and related tools Behaviours and Mindset Extremely customer focused; willing to go the extra mile to ensure a high level of service to the customer. Strong communication and interpersonal skills. Able to communicate clearly with a range of stakeholder verbally and written. A positive, ‘can do’ attitude. Able to be flexible and agile when needed to support the business demands. Is proactive about their own development; curious and interested and willing to learn about new product and services as Freespace grows is product base. A strong interest in technology, particularly electronics. The ability to work quickly and accurately under pressure in a fast-paced environment and adapt to new ad-hoc requirements. Being able to learn from mistakes and not making the same mistakes twice. A strong commitment to quality; motivated to consistently do a high-quality job to the best of their ability. Able to think and act commercially. Excellent team worker; steps up to help the team succeed when needed. Freespace Global Perks Paid annual leave and public holidays to support your work-life balance Paid sick leave if you should fall ill Family Mediclaim Cover & Accidental Benefit Plan Company-sponsored meals in the office Access to funded training (internal/external) to support your career development Chance to refer friends and earn money through our generous Employee Referral Program Global employee award program giving us the opportunity to recognize and celebrate success Chance to get involved in shaping our culture by joining one of our Employee Resource Groups A creative and engaging company culture right across the business Why Apply? Freespace is growing globally and investing in new technologies and innovative ideas to support our customers in the marketplace. This is a fantastic opportunity for a talented professional who is experienced and interested in technology, to join an agile company that promotes further development in your career as well as the ability to learn multiple disciplines. If you find yourself a suitable fit for the role, you can apply directly through Indeed or share your CV at hrindia@afreespace.com

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR, Document Management, Material Management, Training, and Equipment Tracking and Monitoring. Device interface mechanism with various software packages such as Laboratory Information Management System (LIMS), Quality Management Systems (QMS), and PAT etc. Lead cross functional meetings to gather requirements, scope, and business rationale for MES projects. Facilitate design review workshops with process subject matter experts. Offer remote support to overseas projects. Communicate proactively with peers, customers, and management - highlighting and resolving issues, proposing solutions and driving project to completion. Excellent problem solving and analytical skills Conduct training and share knowledge with team members Position requirements: Professional Experience: Experience of design, development, and deployment experience in SIMATIC IT eBR will be preferred, experience on other MES system like Rockwell FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech, and/or Rockwell etc. will be added advantage. Thorough understanding of ISA S88 and S95 models. Knowledge of Pharmaceutical manufacturing process will be an added advantage. Hands-on experience on Distributed Control Systems such as PCS 7, Emerson DeltaV or similar will be an added advantage. Knowledge of Computer Systems Validation, SDLC methodologies and GAMP is must. Excellent written and verbal communication skills. Ability to work within a team, lead cross-functional teams, and work independently in dynamic environments. Willingness to travel for startup and commission activities Key Skills: FTPS, Emerson Syncade, Werum PAS/X MES, Aspentech ISA S88 and S95 models Distributed Control Systems such as PCS 7, Emerson DeltaV Computer Systems Validation, SDLC methodologies and GAMP LIMS, QMS and PAT

** VEDIO CALL INTERVIEW ** Roles and Responsibilities Perform CSV (Computer System Validation) tasks for new systems implementation. Ensure compliance with GMP regulations during software validation processes. Conduct software validation activities according to GAMP guidelines. Key Skills : Good Exposure on CSV,PLC, Software Validation in pharmaceutical industry, SAP,LIMS Qualification, TRIMS,NICHELONS,HVACMS/BIMS,EMPOWER,ELMS. ** Preferred male candidate only. Interested candidate can share their resumes below mail id: sonali.n@hetero.com/9100408534. Job Location : Unit V, Hetero Labs limited, Jadcherla, Hyderabad.