Responsibilities :
- Act as a Validation Lead for multiple products (applications) for GxP compliance
- Assist building a standardized method of enabling / implementing the SOPs for the GxP applications and getting the teams to adopt the standard approach
- Manage and execute validation plans and validation documents for new systems in scope
- Analyze and propose changes to already validated systems and recommend requisite level of validation activities
- Act as project manager for validation projects process
- Coordinate with business to support the required software change
- Help create system requirements and specifications to ensure requirements can be tested to meet the validation goals
- Support auditing of internal computer systems validation activities, protocol and procedures along with preparing appropriate responses
- Initiate / Prepare and closeout all validation related deviations, discrepancies and change control documents
- Support development teams in creating, and maintaining test plans, test scripts and user acceptance tests
- Manage the execution of test plans
- Guide the teams in the proper execution of validation documents
Requirements :
- Overall + years IT experience
- years of relevant experience in computer system Validation preferably in a pharma company
- Experience and good knowledge in CSV / CSA
- Knowledge of GxP
- Have good organization skills
- Ability to work on multiple projects in parallel
- Good verbal and written communication skills
- Ability to provide guidance on revising validation documents and protocols
Validation Lead
Act as a Validation Lead for multiple products (applications) for GxP compliance. Manage and execute validation plans and validation documents for new systems in scope. Analyze and propose changes to already validated systems and recommend requisite level of validation activities. Act as project man...
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