Job Description

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\xe2\x80\x94where your purpose accelerates our mission.

Summary:

Required expertise in Handling Computer System Validation, Qualification, Quality Management System and managing documentation as per current Good Manufacturing Practices norms in pharmaceutical industry. Collaborate with other functions and global subject matter experts to meet the needs computer system validation

Essential Duties and Responsibilities:

• Handling of documents management software for Good Documentation Management
• Handling of BMC Remedy for IT Change control Management
• Active Participation in change control assessment and risk assessment/impact assessment
• Ability to handle multiple projects simultaneously
• Performing System administration of computerized systems
• Experience in Preparation and reviewing of all SDLC documents, protocols and SOP\'s to ensure they meet GxP and FDA regulations
• Experience in IT Infrastructure Qualification
• Ensure system qualification/validation documentation as per policies and procedures, as well as meet regulatory requirements
• Responsible for creation, execution and review of validation packages
• Ensure System Backup and System Audit Trail Verification tests are conducted as per guidelines and FDA regulations
• Handling of internal/external Audit for computerized system.

Qualifications:

• Well versed with regulatory guidelines such as 21 CFR Part 11, EU Annex 11, PIC/S and WHO
• Well versed with principles of Data Integrity and ALCOA++
• Good understanding of GAMP5 guideline and software categories
• Experience in computerized system validation and infrastructure qualification
• Experience in Reviewing and Validating Computer Systems in compliance with 21 CFR Part 11 and Annex11 and other regulatory guidelines
• Must be well-versed in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report
• Experience in reviewing all SDLC documents, protocols and SOP\'s to ensure they meet regulatory guidance
• Experienced in Developing and reviewing User Requirement Specifications, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents
• Working knowledge of GLP, GCP, GMP, GAMP V guidelines especially in the areas of computer or related systems
• Knowledge of Reviewing documents like (IRA, URS, VP, TP, FRS, DRS, FRA, IQ, OQ, PQ, RTM, change control and deviation
• Knowledge on execution of IQ, OQ and PQ test cases
• Experience on preparation of validation deliverables like VP, IRA, URS, DS or CS, TP, FRS, FRA, IQ, OQ, PQ, RTM and VSR.
• Working knowledge of IT infrastructure qualification, software validation and Compliance 21 CFR part 11
• Knowledge about IAAS, PAAS and SAAS cloud system

Education and/or Experience:

• Educational Qualification: Graduate/Master\xe2\x80\x99s in pharmacy / Chemistry or related field
• Experience range (desirable): Between 10 - 15 years

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.

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