Syed Raza

About Syed Raza

Senior QA Investigator, CAPA coordinator, cGMP Trainer, Aseptic Manufacturing…

Experience

1. Sr Quality Deviation Investigator (Remediation)- Consultant

   ALKU

   Jan 2020 — Present

   The primary function of this position is to investigate deviations in the Aseptic Manufacturing and Drug Processing Areas. Responsible for DMAIC process, root cause analysis (RCA), risk assessments, CAPA\'s to prevent recurrence and write a formal report in Trackwise. I am planning, executing, tracking, and completing the key investigations related to Production Fills, EM, Media fills, and Change Management tasks. I work cross functionally with Quality, Aseptic Manufacturing Ops, Maintenance, Facilities, Materials Management, Validation and Training to deliver key milestones and compliance. Responsibilities-Conducting and writing formal investigation reports partnering with the plant personnel- Performing impact risk assessment and determining root causes- Planning, Tracking, Closing and Implementing appropriate CAPAs- Performing reviews and evaluating sensitive, confidential information and developing recommendations for use by Technical Sterility Services department-Utilizing change management systems to update Quality documents and procedures. Liaise with departments such as Mfg and Quality as required-Perform necessary assessments of aseptic operations and update necessary documents -Assist in managing investigation workload for the department to ensure investigations/ CAPA\'s are completed within the assigned time frame- Maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing- Handling multiple projects in a dynamic environment -Being self-directed and act upon decisions that impact the site from an aseptic standpoint-Using pharmaceutical operations (GxP) experience and/or knowledge-Using working knowledge of FDA regulations knowledge of various quality tools prior investigation writing experience (with determination of product impact)- Using Excellent facilitation skills and ability to facilitate strategy meetings-Developing GMP Training system as required.