Company Details

Indian Bio Pharmaceutical Company

Assignment Details

Our client, a leading Indian Bio-Pharmaceutical company is looking for a Digital Compliance Manager.

Key responsibilities:

• Develop and review documentation (protocol, plans, test scripts, reports etc.) associated with the implementation and maintenance of computerized systems
• Represent the compliance / validation team in internal and client meetings and report metrics to management. Be thorough in Various regulatory guidelines & ensure Digital Compliance for Projects.
• Apply standard compliance methods in support of validation activities (e.g. good
documentation practices, statistical sampling, review or inspection, testing and test
management, root cause analysis) for all sub-initiatives under Digital Transformation
• Clearly communicate validation strategies and facilitate all aspects of a risk-based life cycle approach for Computer System Validation on all Digital projects
• Facilitate and document risk as it relates to the implementation of new technology, systems, and tools (e.g. intended use, functional risk), as well as changes to existing/upgrades
• Work closely with sub-initiatives SMEs and Digital Infra Tech vertical to ensure software validation tasks, activities and deliverables are completed within defined time commitments
• Support all sub-initiatives under Digital Transformation for validation activities complying to various guidelines i.e. 21 CFR Part 11, GAMP guidelines, Applications & Infrastructure validations including IQ, OQ, PQ
• Support to establish end-to-end Validation guidance document and rule book framework for managing all validations related needs for Digital initiatives under Digital Transformation.
• On constant look-out for opportunities for improvements.

Secondary Responsibilities (Wherever Applicable): Other activities assigned by Reporting Manager/HOD.

Skills Required

• Knowledge of End-to-End CSV in GxP environment with deep experience in validation life cycle and V-Model.
• Good communication skills.
• Ability to seamlessly support relevant activities.