Validation Lead Vacancy in chennai

Validation Lead Vacancy in chennai

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

This role ensures that software products are complete, accurate, and comply with the company’s safety and quality requirements. Please review the responsibilities below to see if you are a good fit for the validation lead vacancy in Chennai.

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 the testing team
  • Facilitate PQ working with the 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 the medical device/pharmaceutical/health tech 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 the quality of output

· Hands-on and detail-oriented, with a strong ability to coordinate 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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