Process Validation in Pharma Environment

What we need is professionals with processes validation background. Validation in pharma environment, how to write protocols, tests, validations plans in a GxP regulated environment Validation Lead Skillset: · Direct computer system validation (CSV) experience · Use of quality center or electronic protocol/requirements systems (i.e. TIMS) · Strong written/verbal communication skills · Understanding of managing changes to validated systems in a regulated environment Key Deliverables in Validation Role: · Capable of leveraging technical knowledge/experience to apply in redlining URS, FRS, DS documents as a starting point for SMEs · Comfortable managing their own work with little direction/oversight · Able to take information from project team, PM, and readily apply to work · Able to understand the deep NN process (local & corporate) requirements such that work is driven by requirements, not necessarily the way it’s always been done · Set’s best practice with simplicity mindset · Capable of multi-tasking