, process validation, and capability studies (e.g., IQ/OQ/PQ). Create and maintain comprehensive manufacturing documentation...
, PQ). Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO...
to enhance validation processes, including: Automated generation of validation documents (URS, FS, DS, IQ/OQ/PQ protocols... with validation documentation: URS, FS, DS IQ/OQ/PQ Traceability matrices Hands-on experience with GenAI / LLMs (e.g., prompt...
knowledge of loan products and associated system(s) (Loans PQ – loans decisioning system) Proven ability to garner business...
(REST/SOAP APIs, ETL jobs, instrument connectors). Support CSV documentation, change control, IQ/OQ/PQ impact checks...
protocols (IQ, OQ, PQ). Proficiency in risk assessment methodologies (e.g., FMEA). Excellent documentation, communication...
, FS/DS, IQ/OQ/PQ, risk assessments, and traceability. Author SOPs, work instructions, and change control documentation...
with process development, validation (IQ/OQ/PQ), and production ramp-up. Strong understanding of Lean Manufacturing principles...
for manufacturing processes, equipment, and systems. Perform IQ, OQ, and PQ (Installation Qualification, Operational Qualification... validation protocols (IQ, OQ, PQ) for equipment, processes, and software. Strong understanding of FDA regulations, cGMP...
Responsibilities Develop and execute validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes. Document... field. Experience with validation principles and methodologies (IQ, OQ, PQ). Familiarity with Good Manufacturing Practices...