4 Cfr Jobs

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan Where applicable, ensure proper level of software documentation from suppliers (detailed software specifications, architecture diagrams, deployment specs), as well as identification of associated unit and deployment testing prior to release Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans Execution of validation plans and validation documents Qualifications we seek in you! Minimum Qualifications / Skills BE/B Tech Preferred Qualifications/ Skills Familiar with writing tests for Web-based software architectures Knowledge of Software validation process and testing methodologies, preferably in a highly regulated environment (medical, aerospace or equivalent). Familiarity with the processes and legal requirements for pharmaceutical or medical device industry (cGMP's, 21CFR part11, GAMP) would be a plus. Critical thinker and problem-solving skills Team player Good level in English Great interpersonal and communication skills Looking for Immediate to 45 days joiners.

Responsible for Production planning ,finite scheduling with plant team to ensure the efficient delivery of inventory, service and cost objectives. Manage FG inventory, highlight risks of CFR cuts, come up with RCAs and ensure CFR of 98%+ 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. 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