CQV Engineer - Aseptic Process Simulations (APS)

Overview

CQV Engineer - Aseptic Process Simulations (APS) Responsibilities

Draft and implement

Quality System documentation

for validation practices. Author and execute

URS, IQ, OQ, and PQ protocols

in compliance with GDP guidelines. Support qualification stages for

Analytical and Manufacturing equipment . Conduct

Analytical Instrumentation Qualifications

per USP1058 and SOPs. Perform

Automation Assessments

to ensure compliance with 21 CFR Part 11. Coordinate with vendors and internal stakeholders for scheduling

CQV activities . Author documents for

process validation activities

such as aseptic process simulations. Develop and validate

sterilization process cycles . Ensure all validation activities comply with SOPs and

cGMP guidelines . Promote a

right-the-first-time culture

and maintain strong cross-functional team partnerships. Position Details

Seniority level : Associate Employment type : Contract Job function : Information Technology Industries : Pharmaceutical Manufacturing and Biotechnology Research

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