/OQ/PQ validations, and capacity expansions to support business growth and continuity. Support new product introduction...
packaging/filling operations. Familiarity with validation (IQ/OQ/PQ), change control, and batch record review processes...
operational continuity. Qualification, Validation & Compliance Plan, coordinate, and execute IQ/OQ/PQ activities... analytical instrumentation and software platforms, including IQ/OQ/PQ execution. Strong experience with: HPLC LC-MS GC-MS...
parameters using current engineering methods and technologies. Lead large scale process validations strategies (IQ/OQ/PQ... and Abilities Hands-on experience with process validation (IQ/OQ/PQ), risk management (FMEA), and statistical analysis...
, ensuring compliance with GMP and process requirements. Assist with equipment qualifications, including IQ/OQ/PQ...
of medical device manufacturing processes. Design and execute process characterization, validation (IQ/OQ/PQ), DOE, and TMV... (DOE, IQ/OQ/PQ, TMV) Statistical Analysis Root Cause Analysis Medical Device Manufacturing Cross-Functional Project...
. External Basic Qualifications High School/GED and at least 2 years (BA is PQ only) in associate degree in industrial...
, IQ/OQ/PQ equipment validation protocols, re-qualifications, and prepare applicable documents (functional requirements... writing and executing (IQ/OQ/PQ) with systems and equipment on the shop floor is Highly Desired. Experience with cGMP...
with validation processes (UAT, IQ/OQ/PQ). Demonstrated ability to lead cross-functional teams in high-pressure, time-sensitive...
conditions and measurement uncertainties. Maintain calibration databases and ensure IQ/OQ/PQ compliance. Execute activities...