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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

Habilidades: Redacción de investigaciones, Escritura técnica, Writing

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Información del empleador:
( 0 comentarios ) Denmark

Nº del proyecto: #18054889

12 freelancers están ofertando el promedio de $122/hora para este trabajo

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sandeepchndr2011

I have 7 years of validation experience in pharmaceutical industry. I have done process validation for so many bio-pharma products. Give me a chance to prove myself, I am sure you will find exactly what you need.

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ironlion12

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virag2006

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PhDPrachi

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bhavikpatel4389

Respected sir, My name is bhavik. My qualification is master of pharmacy in Quality assurance subject and i have been working with pharmaceutical company since 2012 with regulated plant like USFDA,MHRA,TGA and EU app Más

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