CleaningValidation (North region of PR)
• Formulation of cleaning validation strategy and approach for new and used equipment, for development as well as commercial manufacturing and CAPA’s.
• Resource MUST: broad current knowledge of cleaning validation regulatory compliance in the pharma industry, proven technical background and experience supporting cleaning validation processes, able to provide consulting services of scientific nature from a regulatory perspective in a multi-product pharma site, provide technical support for the execution (materials evaluation, equipment surfaces and detection limits to develop a suitable cleaning validation strategy, Development & execution of cleaning validation documents, including protocols and reports), lead the technical part of problem solving process related to the cleaning execution, propose corrective actions to prevent recurrence, able if needed to respond to regulatory inspections.
• Deliverables: acceptance criteria, levels of cleaning, control of cleaning process, bracketing & worst-case Rating, determination of the amount of residue, prepare cleaning protocol.
• Qualified candidates must provide a detailed resume up to date including detailed descriptions of Cleaning validation project experience.