Sr Quality Engineer, Validation
Baxter International
This listing was originally posted on Baxter International's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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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, execute, compile and review protocols of equipment, utility, process validation, cleaning validation, and facility qualification.
To coordinate with cross functional teams of all departments for execution of all validation activities & inform to Manager regarding any non-conformity from planning and execution.
To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Manager and approved by Manager.
To monitor the QMS elements like Change Control Management, Corrective and Preventive Action, OOS, non-conformance related to the validation activity and prepare investigation report and ensure proper closure of the QMS documents in Track wise.
To review the scheduled validation activity as per calendar and send it to the cross functional & PPA department in advance for execution planning before the scheduled date.
To ensure samples withdrawal during process validation & keep Manager updated about any non-conformity.
To ensure compilation of executed protocols is done online (as applicable) and observation sheets for process validation and other qualifications are duly filled & signed. To ensure the CFS closure of respective documents.
To co-ordinate with projects and other cross functional dept. for prior information on new equipment installation and to prepare the protocol in advance, followed by new equipment qualification and get it reviewed by the Manager.
To attend training of each protocol before execution of any validation and qualification activity.
To collect data & compile summary report for submission to International Regulatory Affairs (IRA) for queries and ANDA.
To update the protocols as per current regulatory requirement to improve the validation documents.
To prepare VMP as per regulatory guideline or any audit compliance requirement and provide it to Manager for review & approval.
To keep the validation document updated from GMP aspect as per regulatory expectation.
Planning and execution of validation activities associated with QMS elements.
To inform the activity or issues which might occur during the shift’s validation activities through daily meeting.
To review and approve documents related to Validation activities and other documents related to Operation.
To assist/participate during internal or external inspection.
Timely completion of assigned trainings.
To be vigilant of safety aspects and record hazard or any near miss in the provided portal.
Any additional responsibility as assigned by the Manager.
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 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.
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