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
15 freelancers are bidding on average $43/hour for this job
Hi, topacademicse will give you best work in Validation in pharma environment about how to write protocols, tests, validations plans in a GxP regulated environment. kindly discuss details regards Rashid.
14 years of Pharmaceutical product Development and technical transfer of validation, CPV,critical process parameters. experience in writing technical protocol,validation protocol.