Mithilesh Thorvat
CSV | CSA | Cloud Validation | RPA Validation | Cloud Migration | Data Center Qualification & Decommissioning | GxP | Quality & Compliance | GAMP 5 | 21 CFR Part 11 | Pharma IT
- Role
- Business & Integration Arch Team Lead at Accenture
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Mithilesh Thorvat
Total 10+ years of experience in a pharmaceutical/Life science industry. Expertise in…
Experience
Business & Integration Arch Team Lead
Aug 2020 — Present · Pune, IN
Authoring, reviewing, and approving Infrastructure Qualification Plans, Specification Documents, IQOQ, System Operation/Maintenance Process documents (SMTD), and Infrastructure Qualification Summary Reports for new data center build-up projects.• Handling end-to-end GxP impacting robotic process automation (RPA) projects, ensuring compliance and validation throughout the project lifecycle.• Drafting Decommissioning Plans, decommissioning reports, and tracking various decommissioning activities related to data center closure projects from a compliance perspective.• Providing validation support for applications migration from on-premises to cloud, infrastructure qualification, and data center closure activities.• Performing computer system validation activities, ensuring full lifecycle compliance with GAMP 5 and 21 CFR Part 11.• Authoring, reviewing, and approving validation documents for data center build projects.• Facilitating CAB approval meetings for change requests.• Reviewing and approving test scripts in MF ALM.• Conducting internal reviews of documents such as change management and system maintenance documents.• Tracking project compliance as per client requirements mentioned in the ODC Manual.• Conducting monthly internal audits of incidents, service requests, and change requests to ensure completion as per SOPs.• Performing project client data protection validation on a monthly and quarterly basis using the Accenture CDP tool.• Tracking onboarding and offboarding as per the Offshore Development Center (ODC) manual.• Providing support during internal information security audits and internal life science compliance audits.
Education
D. Y. Patil College of Engineering and Technology
Bachelor's degree
2009 — 2013
Skills
- Project Planning
- Management
- Hvac Design
- Project Engineering
- Microsoft Office
- Project Management
- Autocad
- Gmp
- Engineering
- Maintenance of Dehumidifiers, Vaccum Pumps, Walk in Chambers.
- Factory
- Preparation of P & Id's of Ahu
- Preventive Maintenance
- Hvac
- Maintenance
- Manufacturing
- Maintenance Planning
- Validation
- Hvac Validation and Qualification
- Operation and Maintenance of Hvac
- Planned Preventative Maintenance
- Mechanical Engineering
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