9 Cfr Jobs

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

GRC professional with good understanding of industry frameworks and standards 2. In-depth experience on Third-Party Risk Management a. Evaluating third party's cybersecurity control and ensuring they are in compliance with organizations standards and industry best practices b. Track and monitor the status of each due diligence review and communicate the status with management and key stakeholders on a regular basis c. Articulate risks and potential options for remediation or compensating controls d. Understand inherent risk assessment e. Perform new and recurring third party security risk assessments, develop mitigation plans, and work with internal stakeholders to assign remediation tracking responsibility 3. Strong business and communication skills 4. Experience in driving meetings with stakeholders 5. Provide advisory and consulting to client on new trends and challenges in enterprise risk management area 6. Experience in design and development of information security policies, standards, and guidelines 7. Experience on SIG (shared assessments), ISO 27001, NIST framework, SOC 1, SOC2, ISO 27001 and HIPAA 8. Lead and drive meeting with top management 9. Design / modify Contract security language / security clauses 10. Co-ordinate and negotiate security clauses with Procurement team and Supplier 11. Experience on GRC platforms 12. Client interface for understanding the IT Governance, IT Risk & Compliance Management Controls as applicable to Infrastructure operations 13. Well versed and hands-on experience for establishing processes, controls and audits of compliances like HIPAA, CFR, PCI DSS & SOX ITGCs. 14. Documentation of as-is IT & Risk management Controls as they are currently being executed in client environment and ensuring that the same controls are followed and implemented in service delivery operations 15. Work with the client & technical teams for change request on any risk or control implementation as well as governance process 16. Participate in internal as well as external regulatory as well as IT security audits. Understand IT Risks and define audit & governance mechanisms for assets, processes & physical security

Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

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 .

Actively contribute to continuous improvement initiatives improve processes, cost reduction ideas, supply chain cost optimization opportunities, or business process initiatives. Responsible for Production planning ,finite scheduling with plant. Required Candidate profile Good exposure into continuous improvement initiatives improve processes, cost reduction ideas, supply chain cost optimization opportunities, or business process initiatives.

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

Joining timelines: immediate to 1 month Candidate should have a minimum of 8+ years overall Experience Relevant should be at least 2-3 years with lead exp Should have extensive experience in Test documenation like Test Plan, RTM, Test Strategy, Test Data, Bug Report, Test execution report including Test Case creation, and Defect Handling (severity Vs priority) Hands-on experience in Validation test plan, Validation test strategy Validation test documentation, and guiding Should have strong experience in Manual Testing Experience in Test case execution and Bug fixes. should be ready to work as individual contributor too along with Lead role. Experience in Test management tools (Jira and ALM),Knowledge of DB testing Expertise in performing different types of testing like Functional Testing, System Testing, Regression Testing. good to have :Life science or Clinical Trail Domain Experience Working in an Agile environment. We also offer: o Group Health Insurance covering family of 4 o Term Insurance and Accident Insurance o Paid Holidays & Earned Leaves o Paid Parental LeaveoLearning & Career Development o Employee Wellness

Seeking Sr. RA Specialist for Product Environmental Compliance. Expertise in medical device regulations, BOMCheck, environmental reporting, and compliance. 5+ years experience in regulatory or product environmental compliance within medical devices

Key Responsibility - Must have 2 - 8years experience from Pharma Back ground only. Lead the maintenance and optimization of GMP production and utility machines, including mixers, reactors, filtration systems, dryers, compressors, HVAC systems, pumps, and other critical mechanical equipment. Develop, implement, and manage comprehensive preventive and corrective maintenance plans to minimize downtime and enhance equipment performance in line with GMP guidelines. Troubleshoot and resolve mechanical failures quickly, ensuring minimal disruption to production operations. Perform root cause analysis (RCA) and develop strategies to avoid recurrent issues in compliance with GMP standards. Ensure all required operational and maintenance documentation is maintained and up to date (e.g., daily logs, maintenance schedules, safety audits as per GMP guidelines & Client defined SOPs). Provide weekly, monthly, and quarterly reports on service delivery performance, safety audits, and budgetary status to senior management and the client. Team Leadership and Development: Supervise, mentor, and train mechanical maintenance technicians and engineers to enhance their technical skills and ensure GMP compliance. Organize and delegate maintenance tasks effectively, ensuring that work schedules are met without compromising on quality and safety. Promote a culture of teamwork, continuous improvement, and safety within the maintenance team. GMP Compliance & Regulatory Oversight: 1. Ensure all mechanical maintenance activities are conducted in accordance with GMP standards, ensuring the integrity and safety of the production environment. 2. Perform regular audits and inspections of mechanical systems to ensure compliance with FDA, EMA, and other regulatory bodies. 3. Assist in preparing for regulatory inspections and audits, ensuring that all mechanical systems are in full compliance with industry standards.