ValidationSectionHead

**Scope:** Manage and ensure the implementation of Process and Cleaning Validation are carried out in compliance with regulatory and QMS. Maintain the Validation status for products through validation lifecycle management. **Key Responsibilities:** In this role, you will be responsible for the following: * Validation Lead is expected to provide support and/or leadership and establish key partnerships across Operations, MSAT, Quality, Supply, Engineering and Regulatory for the PLM project(s) for which he/she is accountable on * Maintain all validation activities in an inspection ready state for any internal and external audits to ensure successful inspection For process Qualification; He/She is accountable on: * Issue site Process validation master plan (at least annually) * Document and sign the PPQ rationale and protocol with developing sampling and testing strategy (as per site VMP, changes & deviations) * Execute PPQ across all operational shifts as needed, including samples withdrawal and sending to lab * Document and sign PPQ report with statistical assessment for variability within batch and between batches (on-going as per site VMP, changes & deviations) For Cleaning Validation; ; He/She is accountable on: * Create cleaning validation master plans and rationales to define the cleaning program , including calculation of maximum allowable carry over (MACO) limit, considering campaign length, DHT and CHT * Execute CV runs,routine monitoring and periodic review for validated cleaning processes across all operational shifts, as needed * Create cleaning risk assessments/hard to clean assessment for each machine and define controls to mitigate any identified risk(s) and the need for dedication if required together with issuing impact assessments in case of product/machine changes * Determine worse case marker based on worse case marker selection tool * Create the cleaning validation protocol, execute the 3 cleaning validation runs and/or 1 verification run and verif