Senior Executive

2 weeks ago


Bhavnagar, India LUPIN Full time

We are seeking a skilled CSV SME to lead and manage Computer System Validation CSV activities in compliance with GxP cGMP and global regulatory standards GAMP5 21 CFR Part 11 EU Annex-11 WHO Annex-5 The ideal candidate will ensure robust validation documentation and lifecycle management of GxP computerized systems across Quality R D and Manufacturing domains Key Responsibilities Quality Compliance Ensure adherence to cGMP GxP EH S and other regulatory requirements Conduct and supervise tasks per SOPs report deviations and quality concerns Monitor training compliance and support audit readiness Technical CSV Responsibilities Lead CSV activities including URS FRS DCS IQ OQ PQ Risk Assessments and Traceability Matrix Manage validation deliverables and ensure documentation aligns with regulatory expectations Oversee periodic reviews change controls CAPAs and system retirements Maintain inventory and indexing of GxP systems and ensure secure data management Provide training on CSV principles and regulatory guidelines Work Experience 7 to 10 years of hands-on experience in CSV within a regulated pharmaceutical or biotech environment Education B Tech Graduation Competencies Stakeholder Management Strategic Agility Customer Centricity Innovation Creativity Collaboration Result Orientation Process Excellence Developing Talent



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