Harmeet Singh

About Harmeet Singh

Having a experience of more than 13 years in Medical Device Industry by providing…

Experience

1. Validation Designer

   Philips

   May 2019 — Present · Pune, IN

   Started a new journey of my career in Product Management with Philips as Validation Designer. Key Responsibilities in this role are-Responsible for ensuring the accuracy, completeness and compliance of validation deliverable by plan/lead/review/train/guide/support of the validation packages in a regulated industry-Actively participate in the Validation Life Cycle of regulated projects by planning validation deliverables, working on validation documentation, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams-Manages the overall validation for the project to ensure predictable outcome-Guide, mentor & coach team members for validation activities in Project-Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation req, company QMS procedures, and industry best practices-Approve the executed testing documentation as a reviewer-Ensuring that the execution of the validation life cycle process meets requirements-Accompanying internal and external audits related to validation, such as FDA, 3rd party and notified body audits-Driving corrective and preventive actions on findings from internal and external quality system audits-Mentoring and coaching managers/engineers in the departments regarding the validation life cycle process-Increasing awareness and maturity level in the validation process by training-Recommend and lead corrective and preventive actions (CAPAs) to improve the validation practices-Plans for validation for a project based on validation requirement, tracks and reports progress to project team on validation-Provide guidance/feedback to project teams in Validation compliance as per the applicable regulatory req. and company policies and procedures-Effectively manage and Maintain validation Lab and ensure available equipment’s Maintenance & calibration schedule is followed

Skills

• Management
• Team Management
• Technical Analysis
• Microsoft Office
• Sales Management
• Project Management
• Business Development
• Engineering
• Manufacturing
• Microsoft Excel
• Business Strategy
• Troubleshooting
• Strategic Planning
• Operations Management
• Project Planning
• Finance
• Analysis
• Marketing
• Marketing Strategy
• Negotiation
• Market Research