Validation Lead

Validation Lead Job Description Template

Our company is looking for a Validation Lead to join our team.

Responsibilities:

  • Ensure initiation/preparation and closeout of all validation related deviations, discrepancies and change control documents;
  • Help development teams develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans;
  • Coordinate audits of internal computer systems validation activities, protocol and procedures, and prepare responses;
  • Act as a Validation Lead for all validation projects;
  • Coordinate business activities and assign business tasks to support execution of software change;
  • Evaluate proposed changes to validated systems and recommend level of validation activities required;
  • Perform project management activities for validation projects process within the scope of an overall system project;
  • Assist with the development of system requirements and specifications to ensure requirements are testable and met;
  • Execute or oversee the execution of validation plans and validation documents;
  • Coach the implementation teams in the proper execution of validation documents;
  • Preapprove test scripts before they are executed and approve after they have been executed.

Requirements:

  • Good verbal and written communication skills;
  • Ability to work on multiple projects concurrently with good organization skills;
  • 6 to 8 years of experience in computer system Validation preferably in a medical device company;
  • Will be responsible for creating and maintaining the V&V Package;
  • Good knowledge of quality management 21CFR Part 11, GAMP, Part 820, ISO 13485-2016;
  • Provide recommendations for resolving deviations from established processes;
  • Review and approve the UAT test scripts pre and post execution;
  • Results driven with a strong customer and quality focus;
  • Hands on experience using Agile and HP ALM applications;
  • Ability to provide guidance on revising validation documents and protocols;
  • Guide Project teams on Validation activities and documentation per the defined procedures.