Sr Assoc, Quality-Audit Trail Review

Sr Assoc, Quality-Audit Trail Review

Baxter Medical Devices
Not Specified
Not Specified

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-where your purpose accelerates our mission.About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis sterile IV solutions infusion systems and devices parenteral nutrition surgery products and anesthetics and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care
Job Summary
  • Review of Audit trails in the Empower 3/ Periodic/ Daily
  • System audit trail review, Project audit trail review, Message Center review, Electronic Signatures.
  • Identify any project integrity failure during backup of Empower data.
  • Review of Audit Trails in Standalone system.
  • Part 11 Compliance, Annex 11 Compliance, Assurance of data path, Verification of IT policies
  • Ensure the timely backup of data generated in the standalone laboratory instruments.
  • Ensure the backed-up data is retrievable and to perform restoration activity periodically.
  • Ensure all the IT policies are in place as per the Baxter's global policies. Perform holistic approach in order to verify duplicate analysis.
  • Ensure date & time policies in all the computers attached with laboratory instruments.
  • Random verification of usage of unauthorized personnel.
  • Verification of global procedures .
  • Compliance on regulatory updates.
Qualifications
  • Post Graduation with proven 7-10 years experience working in Quality Control Function..
  • Critical thinking and Problem-solving skills.
  • Communicating and Influencing.
  • Cross functional collaboration skills.
EEO (Equal Employment Opportunity)
Baxter is an equal opportunity 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. 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 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 . 042575

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