Validation Lead Job in Smartpoint Technologies Pvt. Ltd.

Validation Lead

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