JAYANT PATIDAR

To be a successful member of the pharmaceutical fraternity.

Collaborative leader partners with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

• Received first position in painting competition at college level.
• Represented alma mater in state level athletics competition in Gwalior, year 1999-2000, and secured Third position 100m hurdle race.

• Total Experience: 16.2 Years
• Father's Name: Late. Laxmi Narayan Patidar
• Mother's Name: Mrs. Girija Patidar
• Date of Birth: 04/10/85
• Gender: Male
• Nationality: Indian
• Marital Status: Married

• Functional owner for qualification of Documentum, Trackwise, Validator, Tableau applications.
• Review site level computer system validation document, audit trail, user access management of manufacturing and laboratory systems.
• Ensure compliance of all quality project software's as per 21 CFR, part 11 and Annex 11.
• Validation and deliverable preparation, review and approval as per GAMP 5.
• User access management, privilege right matrix, security controls and other administrative-related knowledge.
• Preparation and review of user requirements related to specific pharmaceutical processes, project plans, validation plans and assessment of associated risks, design script of operational qualification and validation summary.
• Tracking and management of project deliverables related to system validation, training manuals, Implementation at sites, etc.
• Performing software vendor assessment and periodic reviews of software.
• Co-ordinate with vendor for CSV and new functionalities in software with user acceptance test and as per company requirement.
• Troubleshooting software breakdowns, review of defects/ deviations and suggesting appropriate corrective actions including escalations to software development team to resolve the bugs.
• Responsible for Backup & Restoration and monitoring.
• Prepare corporate guidance, standard operating procedure for procedural and operational activity.
• Process improvement initiatives based on learnings from trouble shootings; explore new technologies / functionalities to simplify complex processes, like in Validator system for continued process validator.
• Exposure to various regulatory agencies (USFDA, PIC/s, WHO etc.) audits as well as audit preparedness activities related to IT systems.
• Ensure project requirements met timely and get completed within defined timeline.

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