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.