Description
Specific Responsibilities and skills for Position :The individual in this role is a seasoned software quality/computer system validation professional seen as an expert within the organization on testing and validation. This role is expected to lead complex testing and quality challenges such as those involving cross-functional impacts and multiple compliance and regulatory concerns.
- Establish the validation strategies and plans for GxP computer systems and ensure the validation deliverables for computer systems meet the internal quality standards and external health authority requirements, e.g., FDA, European Medicines Agency
- Develop validation strategy for GxP projects, including resource requirements and schedule; lead validation teams
- Lead and document computerized system risk assessments.
- Create and/or review validation documentation such as Validation Plan, URS, Functional Requirements, Design Documents, IQ/OQ/PQ and associated test scripts, and Validation Summary Packages.
- Review computer system change requests and perform impact assessments.
- Participate in issue investigation and associated CAPA identification, management, and resolution.
- Support various initiatives to enhance the IT Quality, Security and Compliance capabilities of the organization, e.g., improve policies, procedures, measures and skills
- Work closely with IT Team members to provide guidance and advocacy of QS policies, processes and toolset and support QS awareness and training program
To find out more about Real please visit www.realstaffing.com