Assoc Mgr, Quality - Comp Sys Val Job in Baxter

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• 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 created them as required by the company policies.

• To actively engage in review of check lists, 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.

• To responsible for generation of validation plan (VP), gap analysis at sites to gather requirements for the configuration of new softwares

• To prepare an inventory of the computerised system and creation change control documents related to the software.

• To play a major role in QC and manufacturing for computerised system validations

• To train users and other team members in carrying out validation activities successfully.

• To train the projects team members in Good documentation practices (GDPs) and ensure the completion of applicable standard operating procedure and validation trainings.

• To investigate QC computerised systems related non-conformities, recommended corrective actions and review related technical reports.

• To initiate and keep track of documents change request (DCR), Change control Management (CCM), Non-Conformity (NCR) and Corrective and preventive actions (CAPA) as per requirements in consultation with Sub-Department Manager.

• 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 principle of ALCOA++ for validation docs

Reasonable Accommodations

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.