This is where your work makes a difference At Baxter we believe every person regardless of who they are or where they are from deserves a chance to live a healthy life It was our founding belief in 1931 and continues to be our guiding principle We are redefining healthcare delivery to make a greater impact today tomorrow and beyond Our Baxter colleagues are united by our Mission to Save and Sustain Lives Together our community is driven by a culture of courage trust and collaboration Every individual is empowered to take ownership and make a meaningful impact We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results Here you will find more than just a job you will find purpose and pride 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 software s 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 Equal Employment Opportunity Baxter is an equal prospect employer Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability handicap status or any other legally protected characteristic Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information Recruitment Fraud Notice Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and or financial information To learn how you can protect yourself review our Recruitment Fraud Notice

📌 Sr Quality Engineer, Validation (Gujarat)
🏢 BAXTER
📍 Gujarat