Key Responsibilities:

Computerized System Validation (CSV):

- Provide validation expertise on GxP-compliant applications in the drug safety space.
- Serve as SME in CSV practices, ensuring best practices are consistently followed.
- Review and approve key CSV deliverables: Requirement Specifications, Validation Plans, Test Plans, Traceability Matrix, Test Summary Reports, Qualification Scripts, and Validation Summary Reports.
- Lead validation and UAT activities for client product implementation projects.
- Guide the testing team in manual and automated testing, OQ, PQ, IQ, and other SDLC artifacts.
- Support internal QA team during client, internal, and regulatory audits.
- Apply risk-based system validation approaches and the V-Model methodology.
- Collaborate with SMEs for requirements analysis, risk assessment, profiling, and mitigation.
- Oversee Change Control, Deviation Handling, Document Management, and CAPA procedures.

Quality Assurance Operations:

- Maintain solid knowledge of GxP, GDP, GTP,



QA best practices and regulatory compliance (FDA, EMA, MHRA, PMDA).
- Ensure adherence to 21 CFR Part 11 and EU Annex 11 guidelines.
- Anchor updates to QMS and participate in continual improvement programs.
- Coordinate revision, review, and approval of IT SOPs and GxP documents.
- Train and mentor resources on QA practices and CSV.

Team and Stakeholder Management:

- Manage, mentor, and coach a team of QA professionals, including onboarding, career development, and performance evaluation.
- Engage with clients to build confidence and maintain relationships.
- Conduct capacity planning and resource forecasting.
- Ensure effective management of multiple projects while maintaining the balance between quality and productivity.
- Oversee cross-training of staff and promote teamwork and motivation.

📌 Manager - IT QA & CSV (Noida)
🏢 RxLogix
📍 Noida