Anya Marsh Email and Phone Number

• Performed and executed Validation, Qualification and Re-Qualification protocols for the Manufacturing Equipment /Process and aseptic areas.• Authored validation documents independently such as OQ and final summary report for the retrospective qualification of HPLC columns.• Authored validation documents such as IOQ for the qualification of new replacing HPLC columns• Executed Operational Qualifications (OQs) to make sure that the columns are capable of consistently operating between established limits and tolerances.• Worked with Document Management System for managing technical documentation of project.• Assisted the project manager in documenting SOPs, review of Batch Records in developing procedures for proper resin packing method in production phase• Ensured complete 21CFR part 11 compliance assessments for manufacturing systems• Involved in documenting the Validation Master Plan in accordance with FDA regulations, particularly 21 CFR 210, 211, GLP and GMP .

The project involved implementation of the reporting module in LIMS and its execution, and computerized laboratory instrument validation with Waters Empower CDS.• Prepared and documented procedures of the validation life cycle for laboratory equipment and maintenance to ensure compliance with FDA rules and regulations.• Validated computer systems and laboratory instruments as per cGLP guidelines and 21 CFR Part 11 to maintain electronic records.• Involved in developing Validation Master Plan (VMP) for the implementation of LIMS and customizing the interface with the instruments based on CSV Risk Assessment Model.• Ensuring site on-time implementation of LIMS through support of requirements definition, functional design, master data configuration and data migration, system validation, SOP revisions and end-user training. Provide technical support of LIMS to Quality Control Operation.• Reviewed validation related documentation of IQs, OQs and PQs.• Involved in performing GAP analysis and remediation plan for potential risks and failures for process and product.

The project was writing the scripts for validation of ARGUS Safety, the Adverse Event reporting System (AERS).• Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.• Routed computerized systems documents Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report using SAP and eDOCs for review and approval.• Was involved in validation of ARGUS Safety by creating a Validation Master Plan and IQ, OQ and PQ of the software system.• Involved in ensuring all compliant pre and post marketing safety reports. Wrote test specifications, testing methodologies and user manuals for Argus Safety.• Contributed to the identification and implementation of process and system enhancements to improve Adverse Event dictionary maintenance and designing templates of reports for electronic report submission.