. Author and execute qualification protocols (URS, DQ, IQ, OQ, PQ) in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex...
requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices. Regulatory...
requirements gathering, risk assessments (GAMP 5), protocol development (IQ/OQ/PQ), and traceability matrices. Regulatory...
, validation master plan, develops validation protocols for PQ, supports IQ/OQ in conjunction with the engineering team. Lead...
, etc.). Preferred Qualifications Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities...
, PQ) using statistical tools (e.g., Minitab) for data analysis and decision-making. Oversee product testing and analysis...
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems...
and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards. Execute activities required for the...). Experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. Communication Skills: Clear...
and process validation (IQ,OQ,PQ) Create, implement, and maintain standardized process control plans. Comply with company policy...
engineering and validation protocols, to support process validations (IQ/OQ/PQ) and the creation of statistically derived product...