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We envision new ways of providing physicians, pharmacists, and nurses with technologies that not only treat chronic diseases but also work to prevent them. We’re looking for team members who are motivated to learn, grow, and innovate while making a meaningful difference for millions of people around the world.
Position: Sr Associate – Computer System Validation
Department: Quality Control
Location: Ahmedabad, Gujarat, India
- To ensure that all the computer system validations activities are carried out in accordance with the approved procedure and protocol.
- Ensure all the validations/qualification activities are completed as per the predefined schedule/timeline.
- To provide training on computer system validation and regulatory expectation to all levels of employees.
- To support life cycle processes such as change control and documentation Management
- To Review / approve the Gap/ risk assessment plan, assessment checklist for GxP Computerised system based on GAMP 5 guideline.
- To review and approve all recommendation points of GAP/risk assessment with respect to EU Annex 11, Gamp5, 21 CFR part 11, and other regulations.
- To review and approve of all validation documents based on the principle of ALCOA++ for validation docs.
- To ensure that all appropriate quality procedures are in place to support the computer system Validation process.
- To monitor compliance with regulations and established standards.
- To review and approve of all QMS documentation related to CSV activities.
- Actively participate with external agencies and ensure execution of validation activities
- To ensure that the facility/equipment/systems/utilities used are in a validated state as per the internal procedures and in line with regulatory expectations.
- To ensure the computer system validation approach follows the requirements of the recent regulatory guidance and Global Quality Procedures.
- To be responsible for the CSV team planner of validation activity.
- To review the summary of the validation activity and provide inputs for continued process verification.
- To prepare/review the Validation and qualification protocols/reports.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.