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Validation Designer - BioMedical

10.00 to 0.00 Years   Pune   02 Feb, 2021
Philips
Job LocationPune
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

nullYou are responsible for

  • 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.
  • Responsible for ensuring the accuracy, completeness and compliance of validation deliverables 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 in Project/Program.
  • Work cross-functionally to implement improvements to the validation practices; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
  • Approve the executed testing documentation as a reviewer
  • 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 requirements and Philips Healthcare policies and procedures.
  • Effectively manage and Maintain validation Lab.
  • Track and ensure available equipment s preventive maintenance & calibration schedule is followed.
You are a part ofA strong team that drives deployment of compliant, efficient, and effective systems and processes in Philips R&D. The Validation Manager is a key role within the PQMS group with interactions across IGT sites and central teams.To succeed in this role, you should have the following skills and experience
  • Bachelor s degree
  • 10 years of experience in highly regulated company with Validation knowledge
  • Working Knowledge of medical device regulations 21CFR part 820, IEC62304, ISO 13485 (preferred)
  • Knowledge on V-model, GAMP5 methodology
  • Leadership experience
  • Self-motivated and able to work independently
  • Good communication skills, team player
  • Training skills (Preferred)
Why should you join Philips Working at Philips is more than a job. It s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.To find out more about what it s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.,

Keyskills :
preventive actionsquality systemtraceability matrixdeviation managementproject teamscommunication skillslife cycleexternal auditiso 13485protocol development

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