Validation Lead

Validation Lead

Department: IT
Project Location(s): Chennai
Education: Any Graduate

Responsibilities

  • Accountable for planning validation activities and reviewing all validation deliverables as per the agreed process with Quality across all programs in the Innovation and Solutions Tribe
  • Accountable for accuracy and completeness of all validation deliverables
  • Facilitates IQ working with Platform Analysts, DevOps Engineers and other stakeholders
  • Facilitates OQ working with testing team
  • Facilitate PQ working with business user community
  • Facilitate sign off by Quality
  • Coach and guide the team of validation engineers
  • Provide guidance/feedback to the project teams related to validation processes as per the applicable regulatory requirements

 

Skills/Experience

Experience in IT Software Validation methodology in medical device / pharmaceutical / healthtech industry

· Experienced as validation lead in at least three global software development implementation projects

· Expertise in FDA E2E Validation, GAMP 5, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 11

· Experience in validation of enterprise-wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP5 and FDA guidelines

Soft Skills Required

· Clarity of thought and vision

· Excellent communication and presentation skills

· Highly driven, energetic, flexible, resourceful ability to multitask

· Excellent influencing and conflict resolution skills

· Ability to ideate and bring solutions to the table

· Adherence to timelines, without sacrificing quality of output

· Hands on and detail oriented, with a strong ability to co-ordinate across cross functional teams

· Continuous improvement mindset

how can we help you?

Contact us at the SmartPoint office nearest to you or submit a business inquiry online.

They reserved a good amount of time to understand my software development requirements. That translated to a high-quality product.

Tony Chatterjee

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