Validation Lead

Posted 05 Sep 2023

Bangalore, Karnataka - India

Req Id 262344


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Job Title- Validation Lead (Expert)


Job Location: Electronic City, Bangalore

Shift Timings: 1:30 pm – 10:30 pm


Healthcare Digital, Data and IT organisation shapes the digitization of Healthcare by delivering new IT solutions for Healthcare R&D, GHO and M&S functions. We are globally represented in Germany, USA and India and are working in a highly regulated environment and compliance is mandatory for both project and service delivery. We have established a Center of Excellence for Validation, Qualification, and Testing and are looking for a Validation Lead (Expert)


In this role,

  • You will apply your superior subject matter expertise to ensure validation of existing and new computer systems and associated interfaces.
  • You are responsible for validation planning and execution, includes the definition of the validation and testing approach and the coordination of the respective resources and activities.
  • You will author key deliverables and ensure high quality output across the team.
  • Applying your organizational and technical understanding, you will onboard team members from our internal and external VQT partners and manage the services for business units and functions within healthcare
  • You are responsible to prepare and support audits


Who you are:


  • Minimum B.Sc. Degree in Science or Engineering or equivalent
  • Proficiency in both written and spoken English
  • Minimum of 10 years of combined experience in Pharmaceutical area
    (i.e. Validation / Quality Assurance / Project management)
  • In depth knowledge of and experience with Computer System Validation and SDLC process
  • Intercultural experience and excellent communication skills
  • Knowledgeable in 21 CFR Part 11, GCP and GLP regulations
  • Thoroughly familiar with Quality & GxP IT compliance requirements
  • Excellent analytical skills sufficient to lead complex problems resolution, make
    accurate and consistent interpretations and present high-level reporting for
    weekly operations meetings and monthly service reviews.
  • Ability to familiarize himself / herself independently with entirely new subjects
    and thus provide comprehensive and innovative solutions
  • Excellent written and verbal communications skills
  • Working knowledge of information security and best practices


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