95 Gxp Jobs - Page 3

Develop and implement the company’s IT strategy, aligning with business goals. Oversee the IT infrastructure, including networks, databases, and software systems. Ensure data security and compliance with relevant data protection regulations.

What you will do Let’s do this. Let’s change the world. In this vital role you will be responsible for designing, developing, and maintaining software applications and solutions in the Regulatory and Clinical Trial submission product team that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers supporting applications like docuBridge Suite from Lorenz and Disclose from Citeline, developing scalable solutions, automating operations, monitoring system health, and responding to incidents to minimize downtime. The ideal candidate will have a strong background in regulatory submissions and clinical trials, along with innovative and transformational experience. Roles & Responsibilities: Take ownership of complex software projects from conception to deployment Manage software delivery scope, risk, and timeline Possesses strong rapid prototyping skills and can quickly translate concepts into working code Provide technical guidance and mentorship to junior developers Contribute to both front-end and back-end development using cloud technology Develop an innovative solution using generative AI technologies Conduct code reviews to ensure code quality and alignment to standard methodologies Create and maintain documentation on software architecture, design, deployment, disaster recovery, and operations Stay updated with the latest trends and advancements Work closely with the product team, business team, and other partners Design, develop, implement, and maintain applications, including configurations, custom reports, interfaces, and enhancements Analyze and understand the functional and technical requirements of applications, solutions and systems, and translate them into software architecture and design specifications Develop and implement unit tests, integration tests, and other testing strategies to ensure the quality of the software Work on integrating applications with other systems and platforms to ensure seamless data flow and functionality Provide ongoing support and maintenance for applications, ensuring that they operate smoothly and efficiently Design and implement systems and processes to improve the reliability, scalability, and performance of applications Develop and maintain monitoring tools and dashboards to track system health, performance, and availability Respond to and resolve incidents promptly, conducting root cause analysis and implementing preventive measures Implement and maintain security measures to protect systems from unauthorized access and other threats What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree OR Master’s degree and 4 to 6 years of Computer Science, IT or related field experience OR Bachelor’s degree and 6 to 8 years of Computer Science, IT or related field experience OR Diploma and 10 to 12 years of Computer Science, IT or related field experience Preferred Qualifications: Functional Skills: Must-Have Skills Have strong eye for business. Can demonstrate a deep understanding of pharma industry regulations and its compliance requirements Have excellent knowledge of submission publishing systems like Lorenz’s docuBridge application and Disclose from Citeline Have knowledge of ClinicalTrials.gov and EudraCT Have good knowledge of Regulatory Veeva Vault Demonstrated experience in managing technology initiatives and teams with a track record of successful innovation and fostering the development of talent. Exceptional collaboration, communication, must be flexible and able to manage multiple activities and priorities with minimal direction in a rapidly changing and demanding environment. Experience in applying technology standard process methodologiesScaled Agile (SAFe), ITIL, etc. Strong knowledge of information systems and network technologies Good-to-Have Skills: Strong knowledge of eCTD specification and highly regulated (GxP) systems Experience in a leadership role within a pharmaceutical or technology organization Extensive experience in the software development lifecycle of GxP Systems. Experience using and adoption of Scaled Agile Framework (SAFe) Strong analytical/critical-thinking and decision-making abilities. Ability to work effectively in a fast-paced, dynamic environment. Established business partnerships and IS governance practices involving senior business partners Broad working knowledge of key IS domains and layers Professional Certifications (please mention if the certification is preferred or mandatory for the role): ITIL (preferred) Scaled Agile Framework (SAFe) for Teams (preferred) Veeva Vault platform Certified (preferred) Soft Skills: Excellent analytical and solving skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements. Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. 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

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.

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. Your Responsibilities include: 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 Benefits 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.

** 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.

Efficiently monitor all operations which affect the quality. Devise procedures for inspecting and reporting all the persisting quality issues. Assure the consistency and reliability of production with thorough checking procedures and final output. Supervise and guide inspectors, technicians, and all other staff. Report all malfunctions to production executives only to ensure immediate action. Appraise all the requirements of customers and ensuring they are quite satisfied. Facilitate proactive solutions by collecting and analyzing quality data. Keep permanent records of quality reports, statistical reviews, and relevant documentation. Review the current standards and policies. Communicate with external quality assurance officers during on-site inspections. Efficiently ensure that all the legal standards are met with great care. Provide assistance during the recruiting process. Efficiently create reports for tracking progress.Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications. Perks and benefits: Mention available facilities and benefits the company is offering with this job.

Primary Function of Position The EQMS Business Analyst will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles. Essential Job Duties Directly participate in the analysis, configuration, modifying and implementation of IT Business Systems Demonstrate good communication, analytical and problem-solving skills to help identify, communicate and resolve system issues in order to maximize the benefit of IT systems Analyze the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices Conduct analysis of system specifications, configurations and develop appropriate documentation Create detailed specifications and process flows to provide direction to application developers Perform solution designing, requirements definition, functional design, testing and implementation of IT solutions Support, assist and train the users on new modified system configurations highlighting the impact on business processes Maintain IT Business system integrity and application notes, system upgrades, changes, and user updates Work closely with onsite team, off shore team, managers and executives to ensure the release of high quality solutions Comply with regulatory and change control requirements and processes #LI-Hybrid Qualification Required Skills and Experience Minimum 5 years of TrackWise System Analysis experience Experience in Medical Device manufacturing industry and systems regulations (21 CFR Part 11, GxP, GAMP, etc.) and good understanding of CAPA and Complaints processes Perform business requirements gathering, requirements analysis, business system design, installation, configuration, user testing and validation support of TrackWise based applications. Java Programming: Strong knowledge and experience in Java programming, including Java 8 features and beyond. Frameworks: Proficiency in Java frameworks such as Spring, Hibernate, and Apache Struts for building and maintaining applications. Web Technologies: Understanding of web technologies like HTML, CSS, and JavaScript, along with frameworks like Angular or React. Database Management: Experience with database management systems (DBMS) like MySQL, Oracle, or MongoDB, including SQL queries and database design Create workflows, Business rules, TWC automation, Notifications and Migrate updates. Create TrackWise WebServices(Search/Populate/Transfer) using OWS/IWS. Create and Implement Crystal Reports Exposure to integration with SAP ERP and CRM systems preferred Familiarity with Software Development Lifecycle (SDLC) processes Good verbal and written communication skills Ability to work on multiple projects concurrently. Ability to work with minimum supervision or guidance Should contribute in team building measures like Knowledge Management & Mentoring Required Education and Training Minimum education: Bachelor's or undergraduate degree in Computer Science, Information Systems or equivalent experience Preferred Skills and Experience Trackwise & Trackwise Digital experience preferred Additional Information ${jobpostDetails.jobAd.sections.additionalInformation.text }

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 Product Owner , Data engineers, AI/ML engineers to ensure that the technical requirements for upcoming development are thoroughly elaborated and tested . 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? ? 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. 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. Design, develop, and execute test plans to validate data integrity and consistency. Write and execute test cases in HP ALM (or equivalent tool) , ensuring full coverage of functionalities. Perform SQL queries and scripting to verify accuracy across multiple environments. Conduct ETL testing to ensure smooth data transformation and migration. I dentify , report, and track database defects and inconsistencies. Work closely with developers, business analysts, and data engineers to understand requirements and improve data quality. Perform database performance testing and optimize queries to enhance efficiency. Validate compliance with data governance, security, and regulatory standards. ? 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 Experience with Agile software development methodologies (Scrum) E xperience in database testing, ETL testing, or related fields. Strong expertise in SQL and hands-on experience with relational databases (Oracle, SQL Server, MySQL, PostgreSQL, etc.) Experience in test case authoring and execution using HP ALM. ? 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? 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 Experience with Agile software development methodologies (Scrum) 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 of DevOps, Continuous Integration and Continuous Delivery methodology Has experience with writing user requirements and acceptance criteria in agile project management systems like JIRA. ? 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 .

Experience in CSV, GAMP, GXP, 21CFR, Part11. Experience in Documentation Writing Good Communication skills. NP - Immediate to 15 Days Mode - Remote

ABOUT THE ROLE Role Description: The Sr Associate Project Manager is responsible for overseeing a portfolio of projects and/or programs to ensure that they align with the organization's strategic objectives and deliver maximum value and outcomes. This individual works closely across teams to lead and deliver program and project management services through all phases of the Project Management Lifecycle (PMLC), which include initiation, planning, development, execution, control, and rollout. This individual is responsible for successful delivery, cost management, resource management, and risk management to drive business outcomes that provide exceptional value to users. This role involves leading and coordinating the efforts of team members and third-party contractors or consultants to deliver projects according to plan, developing and implementing change management strategies and plans that maximize user adoption and minimizes resistance. Roles & Responsibilities: Define project / program scope, goals, and deliverables that support business goals and objectives in collaboration with senior management and stakeholders Lead the project team in executing the project plan, monitoring progress, and making adjustments as needed Deliver successfully against project schedule, scope, and financial commitments Maintain budgetary responsibility of the project(s) (e.g., develop and issue RFPs for vendor selection) Implementation of cost saving measures based on planning and efficiency Identify potential risks and develop mitigation strategies Ensure that project deliverables meet quality standards, business requirements, and intended outcomes Maintain comprehensive project documentation, including plans, reports, and post-project evaluations Coordinate resources across projects, managing dependencies and resolving conflicts Track ongoing program performance throughout using appropriate tools and techniques, ensuring that the program delivers the expected benefits Basic Qualifications and Experience: Masters degree and 1 to 3 years of Information Security or IT OR Bachelors degree and 3 to 5 years of Information Security or IT OR Diploma and 7 to 9 years of Information Security or IT experience Functional Skills: Must-Have Skills: Proven track record of delivering high impact projects that meet and exceed the project objectives and success measures Extensive knowledge of program and project management methodologies Cost & Budget management with detailed financial tracking experience of projects and/or programs with ongoing status reporting to stakeholders Experience with Agile delivery Product team participation and experience Good-to-Have Skills: Proficiency with program management software and tools Proven ability to execute and deliver on a complex portfolio of projects and programs Experience with delivering successful organizational change initiatives and transformations 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 (preferred) Certified Change Management Professional (CCMP) or equivalent (preferred) Soft Skills: Excellent analytical and troubleshooting skills Excellent leadership and strategic 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 manage 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 Shift Information: This position requires you to work a later shift and may be assigned a second or third shift schedule. Candidates must be willing and able to work during evening or night shifts, as required based on business requirements.

SAP SD Consultant with expertise in Sales Order Management, Transportation & Logistics, Pricing Techniques, and SAP OTC. Must have SAP SD configuration/support experience, integrations and strong cross-functional collaboration. Knowledge of GXP, SOX.

About the role Role Description: Let’s do this. Let’s change the world. In this vital role you will involve working closely with various groups to 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, and supporting regulatory compliance efforts. Roles & Responsibilities: 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. Compliance 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 collaborators 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. 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 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: Skills and Competencies : Good understanding of GxP deviation management, 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, 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 Equal opportunity statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. 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

Role - CSV Consultant Exp - 4+ Years Skills - CVS , CAPA, Gamp, Gxp, SAP / LIMS / LABWARE Permanent: Harjai Computers Pvt.LTD Location: Mumbai Work location - WFO Mode of working- 5 days, Monday to Friday Interview Mode - VC round

Job ID/Reference Code INFSYS-NAUKRI-202337 Work Experience 15-20 Years Job Title SAP SD/O2C/Logistics Solution Architect Responsibilities Lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment, contribute to unit level & organizational initiatives Worked as Subject Matter Expert in SD area Experience as a Solution Architect in Logistics, Functional Lead in SD with experience in implementation, Logistics solution (Conducting workshops, Design, Testing, Data Migration and hyper care cutover activities) Strong knowledge of Sales Process, Intercompany transaction, 3PL Logistics, Toll Manufacturing transactions / business processes and best practices Exposure to other Logistics area like Procurement, Warehouse Management, Transport Management etc. Technical and Professional Requirements: Minimum 15 years of SAP SD experience and should have at least two end to end implementation projects in S/4HANA Experience as Solution Architect in the above programs. Good Knowledge in integration aspects with other modules MM, WM and SD Expertise in S/4HANA simplifications in logistics areas. Deep Knowledge and expertise in Logistics BPML with an ability to guide clients to Industry Best practices. Experience in driving Business process workshops and Fit / GAP analysis Ability to understand business requirements from business users and prepare requirement document, functional specifications. Good understanding of GXP and SOX requirements. Should have working experience in a highly regulated environment. Should be aware of release governance processes and have experience in working on any incident management tool. Handled post go live critical issue resolving till stabilization. Preferred Skills: Technology->SAP Functional->SAP SD Technology->SAP Functional->S4 HANA - Logistics Additional Responsibilities: SAP SD / O2C / Logistics with Pharma Industry experience. The candidate is expected to be a senior Functional Architect for SAP Programs and should possess broad functional knowledge in Logistics domain and in-depth technical knowledge in the SAP SD module. Also, should have proven expertise in Designing, configuring and supporting SAP landscapes. Proactive approach to problem solving. Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation & quality awareness Domain experience in Logistics areas of life science industry or SAP SD S/4HANA certification with professional level (preferred). Educational Requirements Master Of Business Management,Bachelor of Engineering Service Line Enterprise Package Application Services * Location of posting is subject to business requirements

Job description Job Title: Desktop Support Engineer | Pharma Industry | Bangalore /Hyderabad Location Company: Instrumentation and Control Solutions (ICS) Website: www.ics-india.co.in Location: Bangalore/Hyderabad Experience: 2-8 years (Pharma Industry experience mandatory) Qualification: BE/B.Tech/ Any Graduation Key Responsibilities: Maintain inventory of manufacturing automated systems, including PLCs and SCADA systems. Install and maintain computer hardware and peripherals. Install and upgrade operating systems and computer software. Troubleshoot networking and connection issues. Provide recommendations for software or hardware upgrades. Assist in 21 CFR Part 11 compliance assessments during computerized system selection. Prepare and maintain IT-related SOPs for Manufacturing Automated Systems. Participate in the qualification and validation of automated systems from an IT perspective. Prepare daily reports and manage manual backups (weekly/monthly/yearly). Manage service and incident requests via the help desk dashboard. Skills Required: Strong technical knowledge. Basic understanding of computer systems and networks. Eagerness to learn new technologies and processes. Why Join Us? Work with a reputed MNC Pharmaceutical Client. Be part of a dynamic team focused on cutting-edge technology in manufacturing automation. Enjoy a collaborative and growth-oriented work environment. Application Process: Interested candidates can share their updated resumes at hr@ics-india.co.in or contact us at 9109102346 for further details. Note: This is a full-time position requiring candidates with prior experience in the pharmaceutical industry. Connect me on LinkedIn- www.linkedin.com/in/nikita-sen-2a9565114

EY- GDS Consulting Enterprise Risk (ER) – Regulatory Compliance –Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in Computer System Validation for pharma or medical devices and stakeholder management to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers and Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills and attributes for success Prior experience of leading quality and compliance projects in Regulatory Compliance. Sound domain knowledge in pharmaceutical industry in the areas of Quality Management System - Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix, Data Migration strategy and report etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA), ISO 13485:2016 – Medical Devices – Quality Management System Information Security (ISO 27001) or Risk Management certifications What we look for A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What working at EY offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you

Dear Candidates, Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Executive /Sr. Executive" in IT department for Shendra, Aurangabad location: Role & responsibilities : 1. Overall Compliance of IT SOP's and support to Audit requirements. 2. Manage End User Support 3. Server Room Management 4. ISP link Management 5. Vendor Support and Management 6. Printer Management and Vendor Support Management 7. IT Asset Inventory Management 8. Tape Library Management and Maintenance 9. Plant support for any issue of software, hardware and network of Server, client and Standalone instrument computer systems. 10. To do computer system validation of servers, clients and standalone pc at Site. 11. To complete IT related log books as per SOP. 12. Take care of Chromatography and non-chromatography software & Monitoring. 13. Create new database / projects / folders yearly and monthly in all QC instrument PC. 14. Take Daily, weekly and monthly back-up and retrieval of QC instrument PC as per SOP 15. Follow IT SOP's and compliance. 16. Assign the specified and approved rights / privileges to user 17. Disable / delete / modify / deactivate / lock / unlock user account as per approved request from QC. 18. Provide support in case of login issue. 19. Provide support in case any Software / Hardware / Network related issue 20. Implementation and support of new software's and other GxP Software's 21. Audit Representation and Support 22. Support to other sites as and when required Preferred candidate profile Experience: 5to10years of experience in Pharma Industry Education : Any Graduate / BSc IT

Preferred profile : Bachelors / Masters (electronics and instrumentation / Computer science / IT) with 3 5 years experience. Roles & Responsibilities: Ensuring smoot GxP IT operations at site. Ensuring that IT operations in the facility are running smoothly. Effective management of system administration and operations. IT activities are managed in the plant with respect to procedures and policies. Providing necessary support to the plan for the business contunity and maintaining procedures in the facility to achieve 100% uptime GxP IT function. Ensure the periodic review and governance of IT systems to validate their ongoing compliance and effectiveness. Instrument software troubleshooting EMPOWER/FTIR/ICDAS/SCIEX Analyst / Agilent CDS / SEPAX-C PRO / BD FACSUITE / LOVO / DENOVIX / Osmometer / Nucleon cell etc., Knowledge of GXP windows server and active directory and GPO design & management. Participate and support all cGMP / GLP / GCP audits conducted at the site. Manage desktop/laptop support/PC Hardware, L1 AD Maintaining networking LAN/WAN, Printer support. Windows 7/8/10 installation and troubleshooting. Work on MS office, Outlook, Exchange knowledge, AV installation/update, and maintenance. Computer system validation executions To follow good documentation practices Performing any other activity delegated by reporting manager or designated authority. Qualification of servers Preparation of operating procedures Quality management system document handling Privileges executed based on GXP requirements. Audit trail and Event Logs verification

Position Overview: We are seeking a knowledgeable and results-driven CSV Engineer to join our team, specializing in providing expert validation services to our clients. In this role, you will work closely with a diverse range of companies, ensuring the compliance, reliability, and quality of their computerized systems while adhering to industry regulations and best practices. Key Responsibilities: Validation Strategy and Planning: - Collaborate with clients to develop tailored validation strategies and plans based on their specific needs and regulatory requirements. - Assess project scope, goals, and timelines to design efficient validation approaches. Validation Execution: - Design, develop, and execute validation protocols, including IQ, OQ and PQ to verify system functionality and compliance. - Provide on-site or remote assistance during testing and data collection phases. Documentation and Reporting: - Generate comprehensive validation documentation, such as validation master plans, Risk assessment/GxP Assessment, FS, CS, FRA, test scripts, 21 CFR PART 11 Assessment and validation reports. - Create clear and organized documentation that demonstrates compliance and traceability. Change Control and Risk Management: - Collaborate with clients to assess and manage risks associated with changes to computerized systems, ensuring proper change control procedures are followed. - Advise on the impact of changes and recommend appropriate validation strategies. Regulatory Compliance: - Stay up-to-date with relevant regulations, guidelines (e.g.,21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.), and industry trends related to computer system validation. - Apply your expertise to guide clients in meeting regulatory requirements during the validation process. Client Collaboration: - Build strong working relationships with clients, acting as a trusted advisor and validation expert. - Provide guidance, recommendations, and regular updates to ensure successful validation outcomes. Training and Support: - Provide training to Perfect Utilities engineers involved in the validation process, empowering them to understand and implement validation principles. Continuous Improvement: - Offer insights and suggestions for process improvement and optimization within the validation lifecycle. Required Qualifications and Candidate Profile: Diploma, Bachelors Degree or equivalent in technical area preferred 1-5 years of hands-on experience in computer system validation of PLC based complex system preferably across different industries and systems. Knowledge of BMS, DCS, Lab Software Validation, Vision Software Validation. Being familiar with validation principles, regulatory requirements (e.g., 21 CFR PART 11, EU Annexure 11, cGMP, GAMP5, Data Integrity etc.) Proven track record of delivering successful validation projects and ensuring compliance. Excellent communication and interpersonal skills to collaborate effectively with diverse clients. Candidate should be ready for travelling across India. Benefits: As a valued member of our team, you will enjoy the opportunity to work with a range of clients, contribute to their success, and expand your professional network. We offer competitive compensation, a dynamic and supportive work environment, and the chance to make a meaningful impact in the industry by delivering exceptional validation services. If you are a skilled CSV Engineer with a passion for assisting companies in achieving compliance and reliability in their computerized systems, we invite you to join us. Help us provide top-notch validation expertise and contribute to our clients' growth and success.

CSV Overall, 10 + Yrs. of experience in SAP CSV Validation Services. Developing validation strategies and plans for SAP implementations, upgrades, and modifications to ensure compliance with regulatory requirements. Conducting System GMP impact assessment, GAMP category assessment, ERES applicability assessment, Requirement/ Functional risk assessment after establishing communication with relevant stakeholders. Conducting change assessments and impact analyses to identify mandatory validation deliverables. Collaborating with cross functional teams, including IT, Business Process, CSV and Quality Assurance to ensure alignment on validation deliverables. Creation, execution, documentation, and review of validation plan, including FDS, BDS, TDS, test plan/ scripts, IQ/OQ/PQ Protocols, Traceability Matrix, validation reports and Release notification (Go Live). Support in defect management/ discrepancy investigation if any as part of the validation deliverables. Providing guidance and support to project teams on validation best practices and compliance requirements. Submit the complete Change/Incident/Project documentation with evidences for review and approvals by the business/quality teams. Upon acquiring all approvals, shall communicate to the development/transport/Basis teams to deploy the change/incident/project in Production environment. Ensure the change/incident/project in Production environment is deployed without any deviations. Participating in validation related meetings, training sessions. Participate in Governance reviews, status reporting and handling of escalations Keeping abreast of industry trends, regulatory changes, and best practices related to CSV in SAP. Contributing to the continuous improvement of validation processes and procedures within the organization. Support during Client Visit and Regulatory inspections.

Job Title SAP BASIS Solution Architect Responsibilities As a Solution Architect, lead the engagement efforts at different stages from problem definition to diagnosis to solution design, development & deployment in large S/4 HANA transformation programs Create detailed design and architecture, and process artifacts, implement the solution and the deployment plan Connect with senior client business and IT stakeholders, demonstrating thought leadership in domain, process, and technology Contribute to Unit and Organizational initiatives and COEsing potential problems (environments include Sandbox, Development, QA and Production). Technical and Professional Requirements: Minimum 15-year experience with at least 10 years in SAP BASIS. Strong hands-on experience in S/4 HANA and HANA as a database for SAP applications Working experience of SAP applications on Hyper-scalers like AWS, Azure or GCP – reference architectures, native cloud services, compute and storage options for SAP applications, monitoring performance on the cloud Strong experience in SAP migrations – OSDB migrations, HANA migration & Conversion using DOC, DoDMO. Ability to optimize migration/conversion configurations to minimize technical downtime Knowledge of technical integration scenarios between cloud and on premise and between cloud and SaaS applications Experience in Designing & Implementing landscape architecture and sizing for S/4 HANA projects. Hands on experience in SAP BASIS tasks such as Support package and version upgrades, Client Strategy, Problem management and Capacity Planning including EWA analysis Preferred Skills: Technology->SAP Technical->SAP Basis Technology->SAP functional->S4 HANA - Basis Additional Responsibilities: SAP BASIS with experience in any of the following industry (Pharma, Professional Services, Utility, Telecom, Oil and Gas/Public sector/Resources). The candidate is expected to play the role of an expert level Functional Solution Architect in large SAP transformation programs. The candidate should possess strong domain knowledge in Finance and should be experienced and adept at S/4 HANA SAP BASIS module with hands-on expertise. S4 HANA Public Cloud module with hands-on expertise is an added advantage. Proactive approach to problem solving. Good understanding of GXP and SOX requirements Experience in working in Global delivery model will be an added advantage. Excellent team management skill High analytical skills A high degree of initiative and flexibility High customer orientation High quality awareness Educational Requirements Master of Business Administration,Bachelor of Engineering,Bachelor Of Technology Service Line Enterprise Package Application Services * Location of posting is subject to business requirements

Role & responsibilities: - Responsible for Computer System Validation (CSV) of laboratory instruments and computerized systems in compliance with GxP, 21 CFR Part 11, and EU Annex 11 regulations. - Lead CSV activities for lab systems (HPLC, GC, TOC, LIMS, CDS, ELN, Empower). - Prepare validation documents: URS, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, Summary Reports. - Ensure compliance with data integrity (ALCOA+) and Part 11 electronic records/e-signature r requirements. - Collaborate with QA, IT, and vendors for validation planning and execution. - Support system change controls, re-validation, and periodic reviews. - Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11. - Experience with lab systems/software validation. - Excellent documentation and communication skills.

Project Role : Tech Delivery Subject Matter Expert Project Role Description : Drive innovative practices into delivery, bring depth of expertise to a delivery engagement. Sought out as experts, enhance Accentures marketplace reputation. Bring emerging ideas to life by shaping Accenture and client strategy. Use deep technical expertise, business acumen and fluid communication skills, work directly with a client in a trusted advisor relationship to gather requirements to analyze, design and/or implement technology best practice business changes. Must have skills : Computer System Validation (CSV) Good to have skills : Life Sciences Minimum 2 year(s) of experience is required Educational Qualification : BE Summary :As a Tech Delivery Subject Matter Expert in Business Process Architecture, you will be responsible for driving innovative practices into delivery, bringing depth of expertise to a delivery engagement. Your typical day will involve using your expertise in Computer System Validation (CSV) to analyze, design and/or implement technology best practice business changes, while working directly with clients in a trusted advisor relationship to gather requirements. Roles & Responsibilities: Lead the analysis, design and/or implementation of technology best practice business changes using your expertise in Computer System Validation (CSV). Collaborate with cross-functional teams to ensure successful delivery of projects. Provide subject matter expertise to clients and internal teams on Computer System Validation (CSV) and related topics. Stay updated with the latest advancements in Life Sciences and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Computer System Validation (CSV). Good To Have Skills:Knowledge of Life Sciences. Strong understanding of business process architecture and related technologies. Experience in collaborating with cross-functional teams. Excellent communication and interpersonal skills. Additional Information: The candidate should have a minimum of 2 years of experience in Computer System Validation (CSV). Qualification BE

Job Overview: FICO CONSULTANT Location: Bangalore(Kudlu Gate) Position Title: SAP Consultant Experience: 5+ years Industry .Location: Bangalore Employment Type: Full-Time. Location: Bangalore Experience: 5+ Years. 45 years of hands-on experience in SAP FICO Proven track record of implementing and supporting SAP modules. Technical Proficiency : Strong knowledge of SAP configuration, integration, and customization. Understanding of ABAP for debugging purposes (preferred). Industry Knowledge : Experience in pharma and manufacturing industries (preferred). Familiarity with GxP compliance and production environments. Soft Skills : Excellent communication and problem-solving abilities. Ability to work in a team-oriented and fast-paced environment. Educational Qualifications Bachelor's degree SAP certifications in FICO is a plus.n.