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)