GEETESH PATEL

• Company Overview: Lambda Therapeutic is a Global company and has its presence mainly in Asia, USA and Canada Novum.
• Responsible for preparation of Documentation and Review, Execution and New Implementation in application Information Technology Server & cloud for Late phase and Early phase, pharmacovigilance, VAPT Release and Report writing and common Application, ERP Application and Software systems completion Lab Instrument validation methodology.
• Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables as per GAMP CFR Part 11 and EM, FDA, MHRA regulations and guidelines for Pharma and CRO industry.
• Responsible for documenting Test plans that contain Test scripts, Test case, test data and expected results for user acceptance testing (UAT).
• New enhancement or any change for any application cloud/server base and review documents.
• Reviewing User Requirement Specifications URS, Functional Risk assessment FRA and preparation Requirement Traceability Matrix RTM Documents.
• Review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.
• Involved in CSV activity of Enterprise application such as SAP.
• Laboratory information management system (LIMS), electronic Quality Management system (eQMS), electronic Document Management system (eDMS), etc.
• Involved in CSV, concept phase-Requirement gathering to system release to Go Live phase for Software application.
• Preparation of change request for software testing, risk assessment, GAP analysis and mitigation for GAP.
• Review of Scope of Work (SOW), Service level agreement (SLA), Vendor assessment, FAT, SAT for software implementation vendor.
• Review all documents, protocols and SOP's to ensure they meet GxP and FDA regulations.
• Good experience in Gap Analysis and documenting Remediation Plan.
• Managing Passwords and Security Assessments as per the regulatory requirements following the SOP’s.
• Followed Computer System Validation CSV procedure, review and approve Validation deliverables for both CSV IT and Laboratory systems as per GxP GLP, GMP, cGMP.
• Review of Analytical Document Instrument /Equipment and Backup task for computerized systems & Periodic Review of Audit trail.
• Monitor IT QA program as per GxP principles, and other applicable regulations for effective IT Compliance program implementation.
• Review of Validation & IT QA specific documents and its approvals as applicable and support implementing IT compliance in Early, Late phase and BA/BE.
• Support timely & effective conduct of internal audits.
• To ensure that staff members are trained on aspects pertaining to the required SOP’s and associated regulatory requirements.
• On need basis to perform day to day functions, co-ordinate with the team and allocate assignments.
• Lambda Therapeutic is a Global company and has its presence mainly in Asia, USA and Canada Novum.

· End to end Project Implementation, Validation planning and Execution for IT Systems in GXP area,

QC, Stability, Micro, Production in filling the knowledge gaps.

· Validation of enterprise software WATERS SDMS NuGenesis 7.1 and 8 versions over citrix and client installations. Review and author of Validation deliverables URS, FRS, Risk Assessment, Test Plan, IQ, OQ and PQs, Test Report, Requirement Traceability Matrix, System Release Report.

· Validation of Client Software Empower 2.0 and 3.0 versions and review of different CSV deliverables.

· Vendor qualification and GxP Assessment of applications.

· Facilitation of Project Risk Assessment (System and Functional).

· Authoring and reviewing of all documents of implementation phase and reports for various GxP IT systems at regional level.

· Good knowledge of the Change Control Management Process in Pharmaceutical Industry.

· Authoring and reviewing various Validation Deliverables such as User Requirement Specification, Functional Requirement Specification, System Design Specification, Configuration Specification, Test Plans, Test Script, Requirement Traceability Matrix, and Test Summary Report and System release certificate.

· Prepare, Reviewing and Approving Qualification Testing Deliverables-Installation, Operation and Performance qualification.

· Experience in project implementation activities for multiple projects simultaneously, continuous project tracking and planning to foresee any risk or concern ensuring compliance with regulations.

· Validation of standalone systems and software like LabSolutions, Tiamo and Syngistix (AAS).

1. Monitor IT QA program as per GxP principles, and other applicable regulations for effective IT Compliance program implementation

2. Review of Validation & IT QA system specific documents and its approvals as applicable and support implementing IT compliance in Early, Late phase and BA/BE

3. Support timely & effective conduct of internal audits

4. To ensure effectiveness of CAPA management in IT

5. Perform Gap Assessments and support making the remediation plans

6. To ensure that staff members are trained on aspects pertaining to the required SOP’s and associated regulatory requirements

7. Act as DTC for ITQA CSV department

8. On need basis to perform day to day functions, co-ordinate with the team and allocate assignements

9. Harmonization of quality processes and its evaluation

10. Adher to departmental day to day activities and issues

11. To attend / arrange department discussion meeting for opens issues and resolution for querries

12. Preparartion and revision of departmental SOP’s and Maintin the Inventory as per SOP

13. Ensure Validation/Qualification documents are in place for validation activities and are followed

14. Ensure all Validated Computerized systems are in Validated state at all times

15. Support all departments in Validation activities

16. To work as per OECD series on principles of GLP

17. Any other responsibilities assigned by HOD / Management