Validation Lead Vacancy in chennai
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