, preventative maintenance, and basic repairs Execute process validations (IQ/OQ/PQ), including testing, data collection...
Qualification (OQ), and Performance Qualification (PQ). Knowledge of CAPA, change control, and product lifecycle management...
all process validation activities with Quality- IQ/OQ/PQ. Train/Certify MPI Trainer for manufacturing process instructions;may...
, and systems. Write, review, and execute qualification protocols (IQ/OQ/PQ) for new and existing equipment. Identify risks...
, comparability, and stability programs;site and method transfers;product quality impact statements for NCs;and PQ owned regulatory...
documentation, including work instructions, validation protocols (IQ, OQ, PQ), and standard operating procedures (SOPs). Ensure...
(IQ/OQ/PQ) that comply with FDA regulations. Provide troubleshooting focus and direction for the team...
from suppliers Experience in Process Validation – IQ, OQ, PQ Experience in handling SCAR, RCA, CAPA. Experience in document...
for commissioning, qualification, and validation activities, including DQ, FAT, SAT, IQ, OQ, and PQ stages in adherence to industry...
), Process Validation Protocols (IQ/OQ/PQ), Failure Modes and Effects Analyses (FMEA) and knowledge of Design of Experiments (DOE...