Regulatory Compliance Manager - Life Sciences @ Cognizant

Job Description

Cognizant is hiring for a position in Computer System Validation - Regulatory Compliance across India. Experience: 9 to 13 years Location: PAN India Regulatory Compliance - Sr.Lead Consultant (SLC) Qualification: Minimum requirement is a Bachelors Degree in Computer Science, Sciences or a related education (eg life science, medicine, commercial), Masters preferable Responsibility: Regulatory Compliance Expertise: Reviews project plans for CSV deliverables. Has In depth knowledge of IQ/OQ/PQ protocol for medical devices and pharmaceutical applications in order to ensure complete validation in adherence to cGMP and 21 CFR 11 requirements and other regulations. Guide the IT stakeholders through the SDLC process and author project related validation deliverables (Plans & Reports) in accordance with Client policies and procedures. Conduct Data Integrity Assessments for GxP. Involved in ITIL Change management. Consult project team and cross functional client teams on project methodology impacting CSV principles. Process Definition and SME Guidance: Serves as IT SME for various regulatory and vendor audits to ensure the organization and regulatory compliance standards are met for computer systems. Provide project leadership in the development of project requirements, objectives, plans, schedules and tasks for both IT and the business community related to IT compliance activities. Assist in developing strategic processes and procedures (to align with client requirements) in ensuring that the program/project remains in a qualified/validated status throughout the project life cycle. Technology Trends: Support to SC and SLC on service offerings. Audits, Risk and CAPA Management: Support IT audits by providing requested material, facilitating meetings with subject matter experts. Ensure CAPA is implemented for issues identified during quality audits and reviews. Provide audit support (audit readiness checks) to account team. Support client to successfully deal with internal and external audits concerning IT Quality and Compliance. Must Have Skills HP ALM SAP Regulatory affairs,

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Keyskills:   HP ALM SAP Regulatory affairs