Sid Siddiqi Email & Phone Number

Geneva, Switzerland, CH

• Performed Validation on ERP-JD Edwards, HP-QC, LabWare LIMS v7.0 as 21 CFR Part 11 and cGxP Guidelines.
• Worked on Global Quality System Legacy Validation initiative, aiming to define and harmonize requirements for the Validation of GxP applications, and to initiate remediation projects for GxP applications, associated to.
• Reviewed the various project deliverables, includes: Project Plan / Validation Plan / Migration Plan, FRS, Deployment Plan, Trace Matrix, Test protocols, Supporting Documents.
• Developed Functional Requirement Specification (FRS) from User Requirement Specification (URS).
• Developed Installation/Operation/Performance (IOP) Qualifications test scripts and executed them.
• Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating.

South Plainfield, NJ, US

New York, New York, US

• Gathered URS, FS for LIMS Link applications.
• Documented the IOQ validation protocols and reports for Crystal Reports.
• Created Change Requests in Solman.
• Documented Trace Matrix, Interim Report, PQ protocol and Final Report for Lot QC LIMS.
• Documented the Functional Design Specification of INDUSTRIALIZING PRECISION MEDICINE - IPM QA application.
• Documented the URS, RA for IPM and LIMS Link application.

• Facilitated the implementation of a Quality System / Software which complies with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 Guidelines and GxP (GMP, GDP, GLP) Standards.
• Authored and Reviewed Validation Summary and Test Summary reports, for every Change Request.
• Maintained and documented the total number of tests executed in various test environments.
• Authored Test logs created and uploaded the test scripts to HP ALM.
• Involved in Preparation, Execution and Review of CSV documentation comes under GMP.
• Created test instances and performed regression testing for patch attached to HP ALM.

Chicago, Illinois, US

• Documented URS, Risk Analysis, IQ, OQ and PQ for Version Control, ERP systems and Data Solutions systems. Reviewed URS and FRS documents for Jira application. Documented Validation Plan, Test plan, Functional.
• Focused on Electronic Data Capture (EDC)
• Verifying the FMEA and Defining the process flow.
• Generated the documents by using user manuals and the software’s, such as URS, FRS, Risk Assessment, Test Protocols and Validation Reports.
• Reviewed Data sync functionality (e.g. screening, screen failure, completion, withdrawal) is used to ensure that when criteria and patient status data is added or updated in EDC it generates a message to also update.
• Reviewed RAVE e CRF (Correcting Data, eCRF workflow, Log Forms, Recording Study Data, Visits) validations