Commissioning and Qualification (C&Q) Develop, author, and execute C&Q protocols (IQ/OQ/PQ) for the new filling line, focusing...
, comparability, and stability programs;site and method transfers;product quality impact statements for NCs;and PQ owned regulatory...
, preventative maintenance, and basic repairs Execute process validations (IQ/OQ/PQ), including testing, data collection...
studies (IQ, OQ, PQ) and contribute to process control improvements. Assist in root cause analysis, CAPA (Corrective... knowledge of process validation, including IQ, OQ, and PQ requirements. Exposure to PFMEA and risk assessment tools related...
documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Ensure...
, and systems. Write, review, and execute qualification protocols (IQ/OQ/PQ) for new and existing equipment. Identify risks...
Qualification (OQ), and Performance Qualification (PQ). Knowledge of CAPA, change control, and product lifecycle management...
(IQ/OQ/PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team...
Job Description Must-Have Skills Strong expertise in V&V for medical devices · Hands-on experience in: Protocol writing (IQ, OQ, PQ, CSV, system... within a defined timeline Key Responsibilities: Independently author, review, and execute V&V protocols (IQ/OQ/PQ, system...
), and Performance Qualification (PQ) as per manufacturer standards. Basic LC Troubleshooting and Diagnostics: Perform basic...