Syed J.

About Syed J.

Experienced Project and Engineering Management Professional with a demonstrated history…

Experience

1. Process Validation Engineer

   Pfizer

   Sep 2021 — Present · Rocky Mount, NC, US

   Author, review and execute validation protocols. Define strategy, plan, coordinate and execute the core business phases of Lifecycle Process validation activities based on specific assigned role and responsibilities.Responsible for Initiating Change control, Change Impact assessment and associated Change action items and closure of change control for products to be validated.Ensure all validation activities are properly planned and follow internal procedures, quality standards, and external regulatory requirements (e.g, FDA 21 CFR, EU GMP Annex 1) across the execution.Generate Sample Tickets via GLIMs as per acceptance criteria, sample labels and Collect samples during process validation execution and analyze and interpret validation data to determine conclusion.Author detailed validation summary reports and ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans.Work with Validation Leads and SMEs on risk assessments related to process changes and new equipment to identify and mitigate potential validation failures.Work with multi-functional teams in engineering, manufacturing, quality assurance, and other departments to plan, schedule, and execute validation activities and ensuring facilities, equipment, and process readiness for GMP production.Support Validation Leads to Investigate process deviations, lead root cause analysis, and implement corrective and preventive.Maintain accurate and complete validation documentation throughout the equipment and process lifecycle.