Assoc, QA Csv
5 months ago
**This is where you save and sustain lives**
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
- To prepare, review and verify validation documentation such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and update Validation documentation templated as per requirements.
- To prepare, review and verify the Computerised system validation documents such as User requirement specification (URS), Functional Requirement Specification (FRS), Design specification (DS), Configuration Specification (CS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability requirement Matrix (TRM) and Validation summary report (VSR) etc.
- To prepare, review and verify Gap analysis related to the Computerised system documents to identify the missing GxP documentation and create them as required by the company policies.
- To actively engage in the review of checklists, templates, format, test cases and test scripts for simple and better testing, better review of validation documents and easy understanding and assuring compliance of Computerised systems as per current regulatory requirements and industry best practices.
- System administration for Computerized systems
- To prepare an inventory of the computerized system and create change control documents related to the software.
- To play a major role in QC and manufacturing for computerized system validations
- To train users and other team members in carrying out validation activities successfully.
- To train the project team members in Good documentation practices (GDPs) and ensure the completion of applicable standard operating procedures and validation training.
- To investigate QC computerized systems-related non-conformities, recommended corrective actions and reviewed related technical reports.
- To initiate and keep track of document change requests (DCR), Change control Management (CCM), Non-Conformity (NCR) and Corrective and preventive actions (CAPA) as per requirements in consultation with the Sub-Department Manager.
- To review and approve all recommendation points of GAP / risk assessment concerning 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.
**Reasonable Accommodations**
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