Quality Manager, Peptide API & Development
with Operations, Engineering, and Technical teams to support facility scale-up, equipment qualification (IQ/OQ/PQ), process validation...
with Operations, Engineering, and Technical teams to support facility scale-up, equipment qualification (IQ/OQ/PQ), process validation...
with: Military specifications, AIAG standards, IQ-OQ-PQ and SPC charting and capability studies a plus. Machine tool associates...
of machines throughout the conversion area. You will be responsible for completing the required training measures (PQ&T...
Qualification (PQ) protocols. Develop characterization protocols and oversee characterization studies. Prepare qualification... validation and lifecycle management. Experience authoring and executing IQ, OQ, PQ, and characterization protocols. Experience...
logistics buildings and tank farm, including design, verification activities (IV/OV/PQ), user representation for capital... project management, design, resource planning, budget adherence, and qualification/verification activities (IQ/OQ/PQ...
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems...
validation Cleaning validation Equipment qualification (IQ/OQ/PQ) Support tech transfers and new product introductions... validation Cleaning validation Equipment qualification (IQ/OQ/PQ) Proven ability to write and execute validation protocols...
documentation (IQ, OQ, PQ) Develop and implement capacity planning, cost improvement and facilities layout for equipment moves...
CFR Part 11 and EU Annex 11, including authoring and executing IQ/OQ/PQ protocols, managing change control records...
, equipment planning, and process validation (IQ/OQ/PQ). Support new product development by coordinating prototype machining...