95 Gxp Jobs

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is looking for a passionate and experienced Product Management to join our rapidly growing team. In this role, you will help define the product strategy and roadmap for our product lines. The right candidate should have an exceptional track record of solving pervasive customer problems through strategic thinking, user research and data analysis. You will be involved in every aspect of the product development process, from defining the product strategy and roadmap to driving release milestones with the engineering team. Responsibilities Help set the product vision and strategy for the ValGenesis product lines Lead problem discovery to understand customer needs, current challenges, and work closely with design and engineering partners to come up with solutions Transform initiatives and strategic requirements into actionable items on our product roadmap, balancing value narratives across functions Create product goals and related metrics, tracking progress and managing through obstacles to achieve your objectives Partner with Product Marketing to create launch plans that maximize impact Work closely with other product leaders to understand their product vision and trajectory so that you can help amplify it with the right R&D strategy. Establish a close relationship with the business stakeholders to ensure their requirements are translated into the right products. Engage with key customers and community members to drive roadmaps and outcomes. Collaborate with Marketing & Sales to provide input into launch plans, release goals, and go-to-market plans including product marketing and pricing Requirements 5+ years of hands-on Product Management or related experience, including experience with enterprise software products Significant experience in product lifecycle management and working in Agile environment Strong leadership and organizational abilities Great analytical and problem-solving skills. Preferred Relevant enterprise software experience within the Life Sciences industry and solid understanding of GxP requirements Scrum Certifications (Certified Scrum Master, Certified Scrum Product Owner) 10% ability to travel, when required We’re on a Mission In 2005, we disrupted the life sciences industry by introducing the world’s first digital validation lifecycle management system. ValGenesis VLMS® revolutionized compliance-based corporate validation activities and has remained the industry standard. Today, we continue to push the boundaries of innovation enhancing and expanding our portfolio beyond validation with an end-to-end digital transformation platform. We combine our purpose-built systems with world-class consulting services to help every facet of GxP meet evolving regulations and quality expectations. The Team You’ll Join Our customers’ success is our success. We keep the customer experience centered in our decisions, from product to marketing to sales to services to support. Life sciences companies exist to improve humanity’s quality of life, and we honor that mission. We work together. We communicate openly, support each other without reservation, and never hesitate to wear multiple hats to get the job done. We think big. Innovation is the heart of ValGenesis. That spirit drives product development as well as personal growth. We never stop aiming upward. We’re in it to win it. We’re on a path to becoming the number one intelligent validation platform in the market, and we won’t settle for anything less than being a market leader. How We Work Our Chennai, Hyderabad and Bangalore offices are onsite, 5 days per week. We believe that in-person interaction and collaboration fosters creativity, and a sense of community, and is critical to our future success as a company. ValGenesis is an equal-opportunity employer that makes employment decisions on the basis of merit. Our goal is to have the best-qualified people in every job. All qualified applicants will receive consideration for employment without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or any other characteristics protected by local law.

Project Role : Security Delivery Lead Project Role Description : Leads the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets). Must have skills : Cloud Security Architecture Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Security Delivery Lead, you will lead the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets).We have a requirement for an AWS Cloud Security Engineer to join our growing cloud security team within a leading global pharmaceutical company. The successful candidatewill play a key role in designing, implementing, and managing cloud security controls to protect sensitive data, research environments, and global infrastructure. This role will focus on AWS environments, ensuring compliance with industry regulations such as GxP, HIPAA, and GDPR. 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 development and implementation of security policies and procedures- Ensure compliance with security standards and regulations- Design and implement AWS cloud security best practices across multi-accountenvironments, ensuring secure deployment of resources. Develop and manage security policies for AWS services including IAM, VPC, S3,RDS, EC2, Lambda, and EKS. Collaborate with DevOps and Infrastructure teams to build automated securityguardrails using Infrastructure as Code (IaC) tools (Terraform, CloudFormation,Ansible). Conduct regular security assessments, vulnerability scans, and penetrationtesting on AWS environments. Monitor AWS environments for security incidents and respond to alerts byworking closely with the Security Operations Center (SOC). Establish and maintain AWS security baselines and continuous compliancemonitoring for pharmaceutical applications. Participate in architecture reviews and threat modeling for new AWS servicesand applications to ensure security by design. Collaborate with governance and compliance teams to ensure cloudinfrastructure adheres to GxP, HIPAA, and GDPR standards. Manage AWS Control Tower security guardrails, SCPs (Service Control Policies),and AWS Config rules to enforce compliance. Provide support for audits, risk assessments, and incident investigations.Required Qualifications:Strong understanding of AWS security services (GuardDuty, Security Hub, Macie,Inspector, AWS WAF, etc.). Knowledge of IAM policies, federated identity management (SSO, SAML, andOIDC), and role-based access control (RBAC). Familiarity with SIEM solutions, logging, and monitoring tools (Splunk, ELK, AWSCloudWatch). Understanding of Kubernetes security (EKS) and containerized applicationsecurity practices. Exposure to pharmaceutical data management, clinical research applications, orbioinformatics platformsCollaborative mindset with a passion for continuous learning and improvement Professional & Technical Skills: -Experience with AWS Control Tower, AWS Organizations, and multi-accountstrategies.-Hands-on experience with cloud-native security tools, infrastructure automation,and DevSecOps practices.-Proficiency in scripting and automation (Python, Terraform, Shell, PowerShell).-Experience in regulated environments (pharmaceutical, healthcare, or financialservices) with understanding of GxP, HIPAA, or GDPR compliance.-AWS Security Specialty or Solutions Architect certification (Associate or higher).- Must Have Skills: Proficiency in Cloud Security Architecture and Strong understanding of cloud security principles.- Experience in designing and implementing secure cloud solutions- Knowledge of security frameworks such as ISO 27001 and NIST- Strong problem-solving and analytical skills.- Excellent written and verbal communication, with the ability to explain complexsecurity concepts to non-technical stakeholders. Additional Information:- The candidate should have a minimum of 7.5 years of experience in Cloud Security Architecture-3-5 years of experience in cloud security, with a focus on AWS environments.- This position is based at our Bengaluru office- A 15 year full time education is required Qualification 15 years full time education

Project Role : Security Delivery Lead Project Role Description : Leads the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets). Must have skills : Cloud Security Architecture Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As a Security Delivery Lead, you will lead the implementation and delivery of Security Services projects, leveraging our global delivery capability (method, tools, training, assets).We have a requirement for an AWS Cloud Security Engineer to join our growing cloud security team within a leading global pharmaceutical company. The successful candidatewill play a key role in designing, implementing, and managing cloud security controls to protect sensitive data, research environments, and global infrastructure. This role will focus on AWS environments, ensuring compliance with industry regulations such as GxP, HIPAA, and GDPR. 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 development and implementation of security policies and procedures- Ensure compliance with security standards and regulations- Design and implement AWS cloud security best practices across multi-accountenvironments, ensuring secure deployment of resources. Develop and manage security policies for AWS services including IAM, VPC, S3,RDS, EC2, Lambda, and EKS. Collaborate with DevOps and Infrastructure teams to build automated securityguardrails using Infrastructure as Code (IaC) tools (Terraform, CloudFormation,Ansible). Conduct regular security assessments, vulnerability scans, and penetrationtesting on AWS environments. Monitor AWS environments for security incidents and respond to alerts byworking closely with the Security Operations Center (SOC). Establish and maintain AWS security baselines and continuous compliancemonitoring for pharmaceutical applications. Participate in architecture reviews and threat modeling for new AWS servicesand applications to ensure security by design. Collaborate with governance and compliance teams to ensure cloudinfrastructure adheres to GxP, HIPAA, and GDPR standards. Manage AWS Control Tower security guardrails, SCPs (Service Control Policies),and AWS Config rules to enforce compliance. Provide support for audits, risk assessments, and incident investigations.Required Qualifications:Strong understanding of AWS security services (GuardDuty, Security Hub, Macie,Inspector, AWS WAF, etc.). Knowledge of IAM policies, federated identity management (SSO, SAML, andOIDC), and role-based access control (RBAC). Familiarity with SIEM solutions, logging, and monitoring tools (Splunk, ELK, AWSCloudWatch). Understanding of Kubernetes security (EKS) and containerized applicationsecurity practices. Exposure to pharmaceutical data management, clinical research applications, orbioinformatics platformsCollaborative mindset with a passion for continuous learning and improvement Professional & Technical Skills: -Experience with AWS Control Tower, AWS Organizations, and multi-accountstrategies.-Hands-on experience with cloud-native security tools, infrastructure automation,and DevSecOps practices.-Proficiency in scripting and automation (Python, Terraform, Shell, PowerShell).-Experience in regulated environments (pharmaceutical, healthcare, or financialservices) with understanding of GxP, HIPAA, or GDPR compliance.-AWS Security Specialty or Solutions Architect certification (Associate or higher).- Must Have Skills: Proficiency in Cloud Security Architecture and Strong understanding of cloud security principles.- Experience in designing and implementing secure cloud solutions- Knowledge of security frameworks such as ISO 27001 and NIST- Strong problem-solving and analytical skills.- Excellent written and verbal communication, with the ability to explain complexsecurity concepts to non-technical stakeholders. Additional Information:- The candidate should have a minimum of 7.5 years of experience in Cloud Security Architecture-3-5 years of experience in cloud security, with a focus on AWS environments.- This position is based at our Bengaluru office- A 15 year full time education is required Qualification 15 years full time education

Req ID: 324406 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft Azure, Exchange O365, DNS, Microsoft Teams, SharePoint, OneDrive, and Identity and Access Management for corporate colleagues and contractors. Must Have skills 1) Must have experience on Windows Active Directory 2) Must have work experience on collpasing domains 3) Must have experience of scheduled/ regular maintainence and Patching 4) Must have exposure AD auditing 5) Work Epxerience with SSSD integration skills 6) Progressive experience with MS Windows uptill Windows 2019, 2022 exposure preferred 7) Migration of AD from OnPrem to Cloud (Azure/ AWS) 8) Work Experience with ADMT tool and good to have with Quest Migration tool Required Experience: 5-8 years of experience with Active Directory administration 5-8 years of experience with Domain Name Service (DNS), including zone management 5-8 years of experience with Windows PowerShell, with ability to develop scripts as needed 5-8 years of experience with Microsoft Azure AD (now Entra ID) 5-8 years of experience with Microsoft Exchange and Exchange O365 5-8 years of experience with Mergers & Acquisitions involving Active Directory and Azure 5-8 years of experience working in GxP or other regulated environments 5-8 years of experience with documentation for systems management 1-3 years of experience with SharePoint for O365, Teams, and OneDrive administration 1-3 years of experience with Identity and Access Management, and Identity Governance 1-3 years of experience with Amazon Web Services (AWS) IAM a plus Required Education: Associates Degree in Computer Science or equivalent. Bachelor"™s degree a plus. Associated certificates in the above technologies a plus Primary: Windows Server 2008 - 2022 (10 years) Active Directory (10 years) DNS (6 years+) Linux Server (4 years+) PowerShell (2 years+) Microsoft Azure (2 years+) ADMT (2 years+) Good To have skills Quest Migration Tools AWS Cloud Route 53 Crowdstrike Netwrix

Req ID: 324412 We are currently seeking a Systems Integration Advisor to join our team in Noida, Uttar Pradesh (IN-UP), India (IN). Position Summary: Performs IT functions such as design, analysis, evaluation, testing, installation, acquisition, modification and support of operating systems, database, or software. Plans, conducts, and directs the analysis of business problems to be solved with troubleshooting and automated systems. This position operates with minimal direction and requires a professional who can take ownership over their work. This position is in support of the Core Services team in Corporate IT at Enlyte. Core Services includes the management of Active Directory, Microsoft Azure, Exchange O365, DNS, Microsoft Teams, SharePoint, OneDrive, and Identity and Access Management for corporate colleagues and contractors. Must Have skills 1) Must have experience on Windows Active Directory 2) Must have work experience on collpasing domains 3) Must have experience of scheduled/ regular maintainence and Patching 4) Must have exposure AD auditing 5) Work Epxerience with SSSD integration skills 6) Progressive experience with MS Windows uptill Windows 2019, 2022 exposure preferred 7) Migration of AD from OnPrem to Cloud (Azure/ AWS) 8) Work Experience with ADMT tool and good to have with Quest Migration tool Required Experience: 5-8 years of experience with Active Directory administration 5-8 years of experience with Domain Name Service (DNS), including zone management 5-8 years of experience with Windows PowerShell, with ability to develop scripts as needed 5-8 years of experience with Microsoft Azure AD (now Entra ID) 5-8 years of experience with Microsoft Exchange and Exchange O365 5-8 years of experience with Mergers & Acquisitions involving Active Directory and Azure 5-8 years of experience working in GxP or other regulated environments 5-8 years of experience with documentation for systems management 1-3 years of experience with SharePoint for O365, Teams, and OneDrive administration 1-3 years of experience with Identity and Access Management, and Identity Governance 1-3 years of experience with Amazon Web Services (AWS) IAM a plus Required Education: Associates Degree in Computer Science or equivalent. Bachelor"™s degree a plus. Associated certificates in the above technologies a plus Primary: Windows Server 2008 - 2022 (10 years) Active Directory (10 years) DNS (6 years+) Linux Server (4 years+) PowerShell (2 years+) Microsoft Azure (2 years+) ADMT (2 years+) Good To have skills Quest Migration Tools AWS Cloud Route 53 Crowdstrike Netwrix

Eligibility Relevant Experience : 7 -15 Years, Notice Period: 0 -30 days Locations: Hyderabad/Bangalore/Chennai/Pune/Mumbai/New Delhi Work Mode: Work From Office/Hybrid Job Description Minimum 2-3 End to End Green Field Implementations on SAP SCM(s/4HANA) Essential Skills and Experience Experienced SAP Supply Chain consultant with exposure to PPDS and how the two products are used in conjunction with required master data. Previous experience in triaging SAP incidents, and liaising with end users to identify and resolve issues. Good communication skills including liaison with various stakeholders via video calls and Emails. Experience of working in regulated environments (e.g. pharmaceutical) and conforming to set policies for producing and maintaining documentation Exposure to functional and UAT testing activities. Additional Preferred Experience Good understanding of GXP requirements Exposure to Service Now IT Service Management tool Experience in providing training to end users who have a limited exposure to SAP systems Previous experience of Change Management processes in a regulated environment Interested can share CVs to samiuddin.khaja@bs.nttdata.com Samiuddin Khaja Senior Executive - Talent Acquisition Talent Acquisition

Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook and PI Vision Hands on experience in implementing, configuring and troubleshooting of OSI PI Interfaces including, but not limited to, OPC DA, PItoPI, RDBMS and UFL and has successfully implemented within several client projects. Good understanding of standards & protocols like ISA S88, ISA S95, OPC etc. Excellent working knowledge of OSI PI systems, including functional and technical features as well as limitations of OSI PI Product suite Responsibilities : IT-OT integrations including Industrial Connectors such as Kepware. Mentors System Analysts and can provide UAT & Validation support. Ability to work with all levels of the organization, both technical and non-technical. Good knowledge in Computerized System Validation, GAMP, GxP environments, Quality Systems. PI Data Access Methodologies AF SDK, OLEDB/ODBC/JDBC Provider, PI OPC DA/HDA Server, PI Web API Willingness to learn special and new technologies (Edge technologies and IoT). Experience and desire to work in a Global delivery environment. Level 100 & Level 200 Accredited preferred

Greetings for day. We are having opening for the role Manager - QMS & Documentation Management in Corporate Quality Department. Department : Corporate Quality Location : Mumbai - Andheri East Qualification - B. Pharm. / M. Pharm / M. Sc. Industry Preferred : Pharmaceutical. Work Experience :12 - 18 years Corporate Experience only. Job Description : Quality Management System (QMS) Oversight: Ensure robust implementation and periodic / Retrospective review of all QMS elements including Change Control, Deviation, CAPA, Risk Management, and Quality Review. Documentation Lifecycle Management: Coordinate periodic SOP revision cycles. Ensure alignment with current practices, regulations, and audit feedback. Maintain SOP revision matrix and history. Electronic QMS/LMS Integration & Control: Develop and deliver orientation programs for new joiners covering company policies, ethics, compliance, and site-specific SOPs. Skill Requirements : Competent in extracting, organizing, and interpreting data from QMS systems for management review and trend analysis. Experience in preparing Quality Metrics, Dashboard Reports, SOP compliance trends, and identifying areas for process improvement Proficient in managing the document lifecycle, Organized approach to multi-department coordination, documentation deadlines, and QMS project execution. GMP Knowledge & Facilitation Skills: Deep understanding of cGMP/GxP concepts and strong delivery of technical training sessions . Interested candidate can share their profiles on pooja.t@encubeethicals.com

The SuccessFactors Administrator will contribute to the administration of our SuccessFactors installation and serve as a System Administrator and resource for our rapidly growing team. This includes deployment activities, configuration, installation, and ongoing improvements on the platform. The individual in this role will work closely with other IT teams, business and functional leaders, and subject matter experts to ensure all project activities are performed to a high degree of quality, meets practice and standards expectations, and ensures delivery in a timely fashion. A blend of technical and problem-solving skills and value-to-business mindset would be an advantage for this role. Essential Duties and Responsibilities: Manage the SuccessFactors application and support 5000+ users from multiple business functions across HMH Ensure application deployments and administration follows controls process Act as a liaison between the technical and functional teams, business functions, and vendors to drive project implementations, deployments, and upgrades Identify process and/or business issues that may arise with the implementation of a solution and recommend process improvements to address those issues Project activities will involve deployment responsibilities for the SuccessFactors platform, along with support for the associated HR team Participate in Agile squads and ensure related the deployment activities follows controls process Certify all user access and changes every quarter Maintain a holistic view of all business system processes and users, to understand functional impacts with regards to configuration, process, workflow and reporting Contribute to ongoing improvements in the value delivered by the IT HR team Adhere to quality standards, pertinent regulatory requirements, and to departmental policies, practices and procedures Address tech debt and make sure we define and enforce process to keep the platform aligned to best practice and standards Perform all other related duties as assigned Competencies: 3+ years of SuccessFactors administration experience Ability to manage integrations across multiple systems that involve bi-directional data sync, API call limitations, bug fixes etc. Experience in the compensation and performance modules. Familiarity with Testing frameworks and design patterns Experience in an Agile organization Excellent communication and interpersonal skills Ability to work cohesively in a team environment Ability to use business acumen to develop solutions to functional and technical issues and be results driven In-depth application troubleshooting skills Understanding of regulations applicable to IT applications (GxP, SOX, GDPR) Ability to provide feedback to manager, peers and team members Creative and analytical thinker with strong problem-solving skills A strong sense of customer service, with proven experience in a similar role In depth application troubleshooting skills. Good to have experience in ADP but not mandatory.

Experience:- 2+ Years. Location:- Electronic City, Bengaluru. Skills:- Authorising, Reviewing, Validation Documents Minimum Qualifications expected for the candidates • Degree in computer engineering / equivalent. with CSV especially in IT pharma enterprise systems • Strong communication skills • A comprehensive understanding of GxP, GAMP 5, Infrastructure Management, Computerized System Validation, (Initial Risk Assessment, Disaster Recovery Process, Data Security etc), and QMS. • Proficiency in project and stakeholder management

Role: System Administrator Department: IT Location: Bidar About Us: Sai Life Sciences is one of the fastest-growing Contract Research, Development, and Manufacturing Organizations (CRDMOs). As a pure-play, full-service partner, we collaborate with over 300 global innovator pharma and biotech companies to accelerate the discovery, development, and commercialization of their NCE programs. We have over 3000 employees across our facilities in India, the UK, and the USA, working together to deliver scientific excellence and customer success. We are a Great Place to Work certified organization with a culture of openness, mutual respect, and inclusivity. We embrace diversity and follow equal opportunity practices across all levels. Key Responsibilities : 1. IT assignments as assigned by Reporting Manager, Corporate ITS and plant HODs. 2. Handling of all GxP Servers at site connected at such as Empower, ICDAS, Historian, Server SlslLab, AD server. 3. Maintaining Data centre activities such as ensuring temperature recording, humidity, pest control, man movements, and safety-related activities. 4. Act as System Administrators in Operating System and Instrument/Equipment (GxP) connected application software, Troubleshooting, and Data backup/restore management. 5. Identifying the data from instrument/equipment connected application software in Lab and Manufacturing areas schedule their backups in backup solution software and maintain the list as per SOP requirements. 6. Performing/Monitoring the data backup as per schedule or manually and maintain the backup media and activities logs as per SOP requirements. 7. Performing the data restore on user’s requests/ periodically, verify it along with users and maintain their activities logs in line to SOP requirements. 8. Performing and maintaining the activities logs logging the applications administration activities such as System Configuration & Security Policies 9. Implementing, Privileges & Roles Management, User Management - User Creation, Modification, Enable/Disable, Lock/Unlock etc.) as per SOP for the Lab and Manufacturing systems 10. Implementing the required security patches at OS level on instruments/equipment’s connected GRP computer systems in Lab and Manufacturing 11. Verification and correction of date & time on Lab and Manufacturing instruments and standalone GxP computer systems. 12. Performing the changes in instruments/equipment connected applications software in Lab and Manufacturing areas as per change management procedure. 13. Completing/implementing the sites IT related Change Controls, Deviations, Investigation Reports, CAPAs, and Audit Observations if any. 14. Execution/Review of computer systems qualification and validation (CSV) activities in Lab and Manufacturing areas systems as per Computer Systems Validation requirements. 15. Facing the internal/regulatory audits and able to demonstrate the required compliance & controls are in place w.r.t. IT systems administrations, Operations, data backup/restore, security, traceability and integrity to the auditors on demand. 16. Implementing the required new/revised SOPs at sites and ensuring the overall compliance of the same. 17. Liaison with IT Infra team and vendors for technical support/escalations w.r.t. Operating Systems (OS), instrument/equipment connected application software, data backups & restore. Experience/Qualification: B.Tech/MCA with 4-9 years of relevant industry experience. Key Competencies (Technical, Functional & Behavioural): 1. Good communication skills 2. Demonstrate ownership and collaboration at work

Information Security GxP Specialist What you will do Let’s do this. Let’s change the world. In this lead role you will support the GRC Governance / Policy & Audit team working closely with Technology teams to help ensure that GxP controls are in place, GxP deviations are managed and monitored, and security standards are met. The GxP Specialist will assist in owning and maintaining GxP deviation records, performing GxP assessments, managing controlled documents, and supporting regulatory compliance efforts. Roles & Responsibilities: GxP Governance Leadership: Support the GRC organization in leading a team of GxP and/or policy analysts performing tasks related to governance, GxP deviation management, document management, and policy exception processes. GxP Deviation and CAPA Management : Manage and own technology related GxP deviations, CAPA, and CAPA-EV records Manage GxP reporting and monitoring metrics for Technology/IT records Collaborate with record owners and QA to ensure timely record resolution Assist in the identification and evaluation of risks associated with GxP deviation records. Identify and support new record owners across IT/Technology (e.g. office hours, ad-hoc meetings, document management support). Attend enterprise network meetings as needed to represent the Technology / IT function. GxP Deviation Monitoring and Improvements: Recommend deviation management improvement strategies across Technology/IT. Collaborate with Quality, IT application, cybersecurity, and business teams to supervise and resolve identified risks and vulnerabilities associated with deviations and CAPA’s. Assist in conducting CAPA applicability assessments, time studies, and related initiatives to identify impacts and improvement opportunities in IT systems, processes, and policies. Supervise, monitor, and report on the efficiency of existing GxP records, trends, and recommend improvements as needed. Governance and Regulatory Support: Ensure compliance with relevant industry standards and regulatory requirements (e.g., GxP, GDPR, SOX, NIST). Assist in proactive measures to facilitate compliance, such as collaborating with stakeholders to initiate periodic reviews Assist in the preparation for audits and inspections by internal and external parties, providing documentation and evidence of IT GxP deviation management practices. Support the development and implementation of IT governance, risk, and compliance frameworks and continuous improvements. Support the development and implementation of IT governance, risk, and compliance policies as well as supporting documentation, and their continuous improvements. Track and monitor document reviews, and support document owners to ensure timely periodic review completion. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The GxP security professional we seek is collaborative and action-oriented with these qualifications. Basic Qualifications: 5+ years of experience in IT GxP deviation management, IT quality management, IT auditing, or information security. Hands-on experience with deviation management tools and associated frameworks (e.g., ISO 27001, NIST, COBIT). Master’s degree and 4 to 6 years of information technology, Cybersecurity, Risk Management, or a related field experience OR Bachelor’s degree and 6 to 8 years of information technology, Cybersecurity, Risk Management, or a related field experience OR Diploma and 10 to 12 years of information technology, Cybersecurity, Risk Management, or a related field experience Preferred Qualifications: Good understanding of GxP deviation management, controlled document management, IT infrastructure & systems, and security standard methodologies. Ability to assess technical and business risk related to information systems. Excellent problem-solving, analytical, and communication skills. Ability to communicate complex GxP and risk concepts to non-technical collaborators. Familiarity with regulatory frameworks and compliance standards (e.g., GxP, GDPR, HIPAA, SOX). Technical Knowledge : Proficiency with GxP deviation management tools, GRC (Governance, Risk, and Compliance) software, controlled document management tools, enterprise change management tools, and security incident management tools. Experience with security controls related to networks, databases, and cloud environments. Soft Skills: 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 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. 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 The Role Amgen is seeking a Supplier Onboarding & Vendor Master Senior Associate who will be part of Amgen’s Global Procure to Pay (P2P) organization. You will be responsible for supporting global supplier enablement activities including supplier on-boarding, vendor master data management, set up and enablement of electronic transacting over shared systems, and catalog management. The Supplier Onboarding Senior Associate role will report to the Supplier Onboarding & Vendor Master Manager. The role will be based in India. Primary responsibilities will include the following: Supplier Onboarding & Vendor Master Management Support business partners on the Supplier On-boarding process, helping resolve issues and addressing any business-critical escalations Research vendor information to determine appropriate contact for validation Conduct vendor outreach for vendor data validation Provide accurate, compliant and timely updates for validation outreach effort Manage outreach email box and respond/resolve issues in a timely manner Coordinate with Global team to ensure validations are performed in a timely manner Support Vendor Master escalation requests for master data maintenance related to blocking/unblocking vendor records and maintain overall master data integrity Understand the link between SAP, Ariba Cloud platform and the Ariba Network Support the monitoring and maintenance of vendor master data on a regular basis, to ensure data integrity and quality Provide regular reporting on Vendor Master data Continuously improve processes and procedures to enhance efficiency and effectiveness of the vendor master process. Supplier Enablement & Purchasing Catalogs Support connectivity of Suppliers to Amgen’s procurement systems Play a central role in managing supplier engagement for new catalog setup including preparing and testing new hosted catalogs and punch-out catalogs Support any ongoing monitoring and maintenance activities of catalogs, including monitoring catalog prices to ensure high accuracy of costs Communicate with local purchasing and technical teams and the supplier to resolve operational issues with catalogs. Provide related support to various stakeholders (e.g. answer questions, give requested support/advice, conduct trainings). Basic Qualifications Master’s degree OR Bachelor’s degree and 5 years of Finance experience OR Associate’s degree and 7 years of Finance experience OR High school diploma / GED and 10 years of Finance experience Preferred Qualifications 3+ years’ experience in Procure to Pay space, particularly working with master data and customer service SAP experience Ariba experience MS office proficiency especially Microsoft Outlook and Excel/CSV Ability to manage time to respond to incoming requests and prioritize appropriately to meet SLAs Motivated and responsive to changing priorities and deadlines Highly organized and reliable with strong attention to detail, verbal communication, and interpersonal skills Strong customer service focus while having a problem-solving attitude Ability to multi-task and work within tight timelines Work independently and take ownership of assigned activities Be a team player 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. Apply now for a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAs 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.

Let’s do this. Let’s change the world. In this vital role you will serve as a Technology supervising the delivery of enhancements and integrations for Medical Information Websites. You will handle full lifecycle project execution — from planning through delivery — while ensuring alignment with global product strategy, GxP/CSV requirements, cybersecurity standards, and Amgen’s governance model. This role also requires close coordination across functional and technical teams, including business collaborators, Salesforce development teams, product analysts, QA/validation, and global platform teams. You will also serve as a liaison between onsite and offshore teams, ensuring seamless collaboration through effective daily handovers, knowledge transfer, and clear communication protocols. Roles & Responsibilities: Lead the end-to-end delivery of digital projects supporting Medical Information Websites and associated platforms. Ensure all activities across development, testing, validation, deployment, and support are delivered on time and within scope, aligned with Amgen’s GxP, CSV, and cybersecurity standards. Develop and manage project plans, timelines, risk logs, resource allocations, and cross-functional dependencies. Drive effective communication and coordination between onsite and offshore teams, ensuring consistent progress tracking and daily handovers. Lead periodic collaborator meetings to review project status, align on upcoming deliverables, and incorporate business feedback. Collaborate closely with global business users, product owners, UX designers, and SMEs to ensure delivery aligns with product roadmaps and customer needs. Coordinate with technical and infrastructure teams, including IDM (Identity Management), Veeva Vault, BioConnect, and Vera Scan, to ensure all technical integrations and platform enhancements meet Amgen’s security and governance requirements. Track and manage project risks, issues, and change requests, calling out as needed to ensure alignment with timelines and business goals. Ensure all teams align with documentation, audit-readiness, and validation lifecycle processes including traceability, testing, and closure reports. Track and report on key metrics, including project health, risks, velocity, and release readiness, providing clear insight to leadership and collaborators. Support vendor management by coordinating deliverables, contracts, SLAs, and escalation paths. Collaborate with change control and configuration management teams to ensure proper adherence to change request processes and release governance. Support ongoing platform performance improvements, release management, and post-deployment monitoring. Contribute to Amgen’s digital governance, demand management, and change management processes. Foster a culture of continuous improvement, agile delivery, knowledge sharing, and innovation within the team. Participate in Agile and SAFe ceremonies including PI Planning, sprint reviews, retrospectives, and release readiness reviews. Ability to conduct the role in accordance to GxP and CSV regulations and requirements What we expect of you We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of experience in Computer Science, IT or related field OR Bachelor’s degree and 6 to 8 years of experience in Computer Science, IT or related field OR Diploma and 10 to 12 years of experience in Computer Science, IT or related field Preferred Qualifications: Must have skills: Consistent track record of delivering high impact projects that meet and exceed the project objectives and success measures Ability to proactively chart the course for project delivery and effectively work through project risks and challenges to successfully deliver business outcomes Strong knowledge of change management principles and methodologies Extensive knowledge of program and project management methodologies Proficient in supporting solutions within regulated GxP and CSV-compliant computer systems, ensuring adherence to validation, audit, and documentation standards Good-to-Have Skills: Proficiency with program management software and tools Proven ability to complete and deliver on a complex portfolio of projects and programs Experience with delivering successful organizational change initiatives and transformations Experience with project analysis tools such as Jira, eBuilder, MS Project, etc. Experience delivering GxP projects in the life sciences space and successfully taking through the required qualification processes (e.g., IQ, OQ, PQ, etc.) Professional Certifications: Project Management Professional (PMP) or equivalent certification (Must have) Certified Change Management Professional (CCMP) or equivalent (preferred) SAFe Agile SCM certification Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and critical thinking abilities Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to lead multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Ability to deal with ambiguity and think on their feet Ability to influence and drive to an intended outcome Ability to hold team members accountable to commitments 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. Apply now and make a lasting impact with the Amgen team. careers.amgen.com

Job Information Job Opening ID ZR_1871_JOB Date Opened 14/04/2023 Industry Technology Job Type Work Experience 8-12 years Job Title Architect City Bangalore Province Karnataka Country India Postal Code 560048 Number of Positions 1 Minimum 8 years of exp in OSI-PI. Excellent understanding of the OSI PI system architecture Primarily an Individual contributor and responsible for a small team. Main scope of work is to provide solution architecture, support business, making sure applications are well-designed and conform to Merck standards. Actively drives the installation, implementation in projects and supports solutions of new technologies and opportunities to optimize technology/IT systems. Hands on experience in configuring/ designing solutions based on OSI PI (Now Aveva). Hands on experience in standard products like OPC UA, OPC DA / HDA etc. Hands on experience in PI Visualization Suite - PI DataLink, PI ProcessBook and PI Vision Hands on experience in implementing, configuring and troubleshooting of OSI PI Interfaces including, but not limited to, OPC DA, PItoPI, RDBMS and UFL and has successfully implemented within several client projects. Good understanding of standards & protocols like ISA S88, ISA S95, OPC etc. Excellent working knowledge of OSI PI systems, including functional and technical features as well as limitations of OSI PI Product suite Responsibilities : IT-OT integrations including Industrial Connectors such as Kepware. Mentors System Analysts and can provide UAT & Validation support. Ability to work with all levels of the organization, both technical and non-technical. Good knowledge in Computerized System Validation, GAMP, GxP environments, Quality Systems. PI Data Access Methodologies AF SDK, OLEDB/ODBC/JDBC Provider, PI OPC DA/HDA Server, PI Web API Willingness to learn special and new technologies (Edge technologies and IoT). Experience and desire to work in a Global delivery environment. Level 100 & Level 200 Accredited preferred check(event) ; career-website-detail-template-2 => apply(record.id,meta)" mousedown="lyte-button => check(event)" final-style="background-color:#2B39C2;border-color:#2B39C2;color:white;" final-class="lyte-button lyteBackgroundColorBtn lyteSuccess" lyte-rendered=""> I'm interested

Dear Candidate Hope you are doing well My name is Bhavani, I am a recruiter from Yallas Technology solutions We are Hiring a job opportunities. please find the position details below. Title: Computer System Validation (CSV) Expert( SAP CSV) Duration: Permanent Position Location: Hybrid/work from home(if client asked, need to work at client location) Notice period- Immediate - 7 days Job Description: You have successfully completed studies in the field of computer science, engineering or a related field. • You are passionate about ensuring compliance and quality in software solutions tailored for the life sciences industry. • You have minimum of 5 years proven experience in the field of CSV / GxP, ideally at a software supplier for the regulated industry. • You have a deep understanding of GxP regulations (such as FDA 21 CFR Part 11, Annex 11, GAMP 5), and HIPAA requirements for handling and securing health-related data. • Strong knowledge of data integrity principles (ALCOA+) and security best practices in validated environments. • You are familiar with risk-based approaches and have a solid understanding of risk management practices in regulated environments. • Experience in preparing, and supporting regulatory audits and inspections, with an emphasis on CSV, GxP, and data privacy regulations such as HIPAA. • You have a problem-solving mindset with strong analytical skills allowing you to identify and address compliance risk and process improvements. • You have a high attention to detail to ensure compliance and qualification accuracy. • You are proactive, you value collaboration & teamwork, and you communicate excellently. • Fluent in English, any additional language is a plus If you are interested please share required details along with resume Full Name: Current or Previous organization: Current Location: Total Experience: Relevant experience as SAP CSV: how many years of experience in CSV: How many years of experience in GxP, and HIPAA: Working as full time or contract: Reason for job change: Any other offers inhand: Are you ready to work at office?: Current CTC: expected CTC: Notice Period: email id: contact Number : Domain name: Thanks & Regards Bhavani Jagannadha Senior IT Recruiter

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) Coordinate and interface with operations and quality assurance department, to develop supporting documentation, execution plans, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations. Initiate and manage validation deviations in the testing of development process and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action. Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets clients standards, GMP and FDA regulations. Perform design review to ensure the equipment is installed and operates according to the user requirement specification.

BDM: CSV/GxP Consultancy Sales *Hunt new clients (Pharma/Biotech/Med Device). Deep CSV/GxP knowledge (3+ yrs sales req). Build relationships, close deals. Travel 50-60%. Competitive base + uncapped commission. Impact patient safety.*

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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. QA Manager What you will do Role Description: In this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients. The QA Manager will support implementation and management of quality assurance activities at the Amgen Technology and Innovation Center, supporting oversight and maintenance of external suppliers and contract manufacturers. You will be responsible for leading a team of quality professionals who will be maintaining and approving various quality documents including but not limited tosupplier documentation, analytical results investigations, CAPA and audit records. This role will involve collaboration with various Amgen teams to ensure seamless handoffs between teams Roles & Responsibilities: Oversee a team of approx. 6 staff, ensuring their activities and priorities are managed in a compliant and structured manner. Ensure team members are appropriately qualified and trained to perform needed activities per company procedures. Conduct goal setting, performance reviews, and compensation planning to align with organizational goals. Develop, implement, and maintain quality records in compliance with industry standards, GMP practices, and regulatory requirements. Continuously improve processes to enhance efficiency and quality, by applying lean principles and automation. Develop, monitor and report metrics to senior management to assess the health of the team’s performance. Develop solutions that are thorough, practical, and consistent with functional objectives. Work cross functionally with various Amgen teams and stakeholders to ensure seamless transition of tasks and continuity across groups. Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. This role may require working in shifts or extended hours within the same shift to support global time zones. What we expect of you Basic Qualifications and Experience: Doctorate degree OR Master’s degree with 4 to 6 years of experience in quality management systems or a related field OR Bachelor’s degree with 6 to 8 years of experience in quality management systems or a related field OR Diploma with 10 to 12 years of experience in quality management systems or a related field. Experience managing staff in a GXP environment Functional Skills: Must-Have Skills: Working foundation in quality assurance roles and proven team leader. Minimum of 6 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations. Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them Good-to-Have Skills: Experience in investigations, project management and trending and analysis Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing. Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes). Proven experience in designing and/or improving processes at conceptual level Desire to partner with internal and external stakeholders across teams Understanding of industry requirements/expectations of a robust Quality Management System and documentation. Soft Skills: 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. 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. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. 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.

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers 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 Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Owner s and customers to define scope and value for new developments. Collaborate with Engineering , testing teams as well as Product Management to prioritize release scopes and groom the Product backlog. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira . Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. ? 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: Has experience with writing use r requirements an d acceptance criteria in agile project management systems like JIRA. Excellent communication skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Experience with Agile software development methodologies (Scrum) Experience of DevOps, Continuous Integration and Continuous Delivery methodology ? Good-to-Have Skills: ? Familiarity with GxP , CFR 21 Part 11 and systems validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Experience with testing and validation tools, and testing frameworks 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) ? Certified Business Analysis Professional (CBAP) (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 .

Role Description? The role leverages domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This role involves working closely with business stakeholders, Data engineers, AI/ML engineers 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 Owner and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. ? Roles & Responsibilities? ? Collaborate with System Architects and Product owner s to manage business analysis activities, ensuring alignment with engineering and product goals. Capture the voice of the customer to define business processes and product needs. Work with Product Owner s and customers to define scope and value for new developments. Collaborate with Engineering , testing teams as well as Product Management to prioritize release scopes and groom the Product backlog. Facilitate the breakdown of Epics into Features and Sprint-Sized User Stories and participate in backlog reviews with the development team. Clearly express features in User Stories/requirements so all team members and collaborators understand how they fit into the product backlog. Maintain and ensure the quality of documented user stories/requirements in tools such as Jira . Ensure Acceptance Criteria and Definition of Done are well-defined. Work closely with UX to align technical requirements, scenarios, and business process maps with User Experience designs. Validate that test scenarios meet feature acceptance criteria and customer expectations. Maintain and ensure the quality of documented user stories/requirements in tools like Jira. Stay focused on software development to ensure it meets requirements, providing proactive feedback to collaborators. Develop and implement effective product demonstrations for internal and external collaborators. ? 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 Proven ability to collaborate with developers to translate business requirements into technical specifications and demonstrated experience in writing user requirement documents. Experience with Agile software development methodologies (Scrum) Excellent communi cation skills and the ability to collaborate with senior leadership with confidence and clarity Experience in writing requirements for development of modern web application Experience of DevOps, Continuous Integration and Continuous Delivery methodology ? Good-to-Have Skills: ? Familiarity with GxP , CFR 21 Part 11 and systems validation Experience in creating and executing validation protocols (e.g., Installation Qualification (IQ), Operational Qualification (OQ)) Experience with testing and validation tools, and testing frameworks Experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & iterative systems development methodologies ? Professional Certifications SAFe for Teams certification (preferred) ? Certified Business Analysis Professional (CBAP) (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 .

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 .

At Smith+Nephew , we design and manufacture technology that takes the limits off living! The IT Business Analyst for Regulatory Affairs will collaborate with business leaders and product owners to define, justify, and deliver IT solutions that meet business objectives, create competitive advantage, and leverage internal and external IT resources. Responsibilities include contributing to strategy, gathering requirements, advising on industry trends, building capability roadmaps for short- and long-term needs, and analyzing processes for improvement and cost-benefit. What will you be doing? Provides Business Analysis and Requirements management in support of Regulatory Affairs group Elicit, define, analyze, and document testable business requirements, collaborating closely with customers, end users, and the IT team. Leverage good communication and analytical skills, business relationships, and business process expertise to understand, document, assess, and drive business change needs to accelerate process improvement and business growth. Drives re-use of existing solution capability or introduction of new technology to achieve program or project objectives Works independently and simultaneously on multiple projects with various domain experts to understand current business process landscape, enterprise alignment, and growth. Business Analysis ownership for [functional processes], Identify and evaluate potential solutions, favouring existing invest application estate. Prepares cases which define potential benefits, options for achieving these benefits through development of new or changed processes, and associated business risks. Measurably improve business process capability and performance indicators for delivered projects Attain a high re-use of technology while driving process standardization for owned processes Drives effective requirements' definition that creates objective, testable requirements that results in a business solution which meets or exceeds the defined objectives. Create functional requirements in Use Cases. Coordinate requirements walk-through and signoffs, verifying with collaborators that Use Cases and process models accurately portray specific business needs. Recommends options that best fit the business needs, value proposition and strategic roadmap. Identifies, analyses, and fixes the root cause of business and technical issues. What will you need to be successful? Education: Bachelors or masters degree in computer science, information systems, business administration, or other related field, or equivalent work experience. Experience : Minimum 5-7 years of relevant technical or business work experience . With at least 3 years of experience in information technology & regulatory affairs . Certification in business analysis is preferred. Proven Experience with Rimsys and PTC Windchill (PLM systems) Solid experience working within GxP-regulated environments , including validation of systems, Quality Systems, and compliance with regulatory standards Business process design and reengineering techniques and methods. Business analysis: takes responsibility for investigative work to determine business requirements and specify effective business processes through improvements in information systems, information management, practices, procedures, and organizational change. Selects and embraces suitable business analysis methods, tools, and techniques, selecting the appropriate approach from predictive (plan driven) or adaptive methods (iterative/agile). Collaborates with partners at all levels in the conduct of investigations for strategy studies, business requirements specifications, and feasibility studies. Designs and manages tests of new/updated processes. Manages selection/creation of relevant scenarios for testing and ensures that tests reflect realistic operational business conditions. Ensure tests and results are documented, reported to partners, and are available for specification of user instructions. Highlights issues and risks identified during testing to business customers. Defines and manages prioritizing, requirements definition, and prioritization activities for initiatives of medium size and complexity. Facilitates input from customers, provides constructive challenge, and enables effective prioritization of requirements. You Unlimited. We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/). Other reasons why you will love it here! Your Future: Major medical coverage + policy exclusions and insurance non-medical limit. Educational Assistance. Work/Life Balance: Flexible Personal/Vacation Time Off, Privilege Leave, Floater Leave. Your Wellbeing: Parents/Parents in Laws Insurance (Employer Contribution of 8,000/- annually), Employee Assistance Program, Parental Leave. Flexibility : Hybrid Work Model (For most professional roles) Training: Hands-On, Team-Customized, Mentorship Extra Perks: Free Cab Transport Facility for all employees; One-Time Meal provided to all employees as per shift. Night shift allowances.

Minimum 10 - 12 years of experience in handling complex large transformation projects Experience in Client Relationship Management – key client stakeholders, understanding their requirements and Outsourcing ability to meet them Experience of leading large teams located across multiple cities in India and across the world. Experience of Driving Digital Transformation across a portfolio of accounts Demonstrates a breadth and depth of operational service delivery management expertise. Preferred: Ability to create technical designs based on functional designs, including, mockups, process and data flow diagrams, etc Ability to gather critical information from meetings with various stakeholders and produce useful reports. Ability to conduct market research for product development Knowledge of cloud platforms (Fundamentals of GCP/AWS/Azure) GDPR, HIPAA/GXP compliance, ERP and SAP application Roles and Responsibilities Lead the delivery of multi-functional,Large -scale Cloud transformation projects Conduct a thorough review of all components in the Project/Program Plan: scope, deliverables, time frame, and cost Stakeholder management ( Internal and external ) Manage the risks, issues, scope changes, unplanned events and other actions of the project and regularly track them to meet the expected outcomes and timelines, building mitigation plans as the program evolves. Work closely with Developers, BA, Quality, Engineering, and cross-functional team to resolve issues that arise during design, implementation and in post-production. Work with external and internal partners on integration and product expansion opportunities.

We are looking for Automation Test Engineer - GXP Validation professionals for our IT services division. who is having experience in below technical stack. Please revert if you are interested with below requested information. Required Skills: Selenium with Java, Automation, Rest Assured, API testing, Bdd frameworks, GXP, / Good x Practice. Qualification: UG / PG Graduates Experience: 5-10 Years Location: Chennai / Coimbatore / Bengalore / Pune Work Time: 2pm to 11pm Work Mode: Hybrid Model (3 Days work from office) Notice Preferred: 0-30 Days. Preferred Project experience: Healthcare, Life science. Responsibilities: Develop and maintain automated test scripts and frameworks. Perform functional testing and manage defects. Utilize test automation tools such as Selenium, Appium, or Cucumber. Apply strong knowledge of Selenium with Java, TestNG, and Jenkins. Conduct mobile automation using SeeTest. Execute API automation testing. Implement functional testing techniques and defect management. Work within Agile frameworks and use tools like Jira and ALM . Good Communication Skills, Stakeholder communication & management. Good to have : GXP Validation CI/CD Mobile Automation Cloud Based Testing Platforms - AWS, AZURE LifeScience Domain knowledge