Assoc., Quality-q&v
2 weeks ago
**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.
To coordinate with all departments for execution of Thermal Validation activities & to inform Section Head regarding any deviation from planning.
To prepare calendars for yearly activity & get it reviewed by Section Head.
To prepare protocol for Validation study and send it for approval one month in advance and plan for execution with Production Planning Availability (PPA) and Production Departments.
To review process validation, qualification planner & send it to Section Head for further review & information.
To ensure material issuance for validations activities & keep Section Head updated.
To ensure implementation of validation, qualification activities & inform to Section Head for any deviation from written procedure.
To ensure sample withdrawal during process validation & keep Section Head updated about any deviation.
To ensure observation sheets for process validation are duly filled & signed.
To coordinate among various departments for process validation, qualification activities.
To conduct Material issuance for validations.
To execute validation, qualification activities & inform Section Head for deviation from written procedure, if any.
To conduct Sample withdrawing during process validation on time & online.
To conduct trainings before execution of validation & reviewed performance of qualification report & report to Section Head.
To conduct new equipment qualification & validation and get it reviewed by Section Head.
To collect data & compile report for preparation of Change Control Note (CCN), Deviations International Regulatory Affairs (IRA)/ Regulatory / Queries / Compliances / Submissions / In-Process Quality Assurance (IPQA) data / Corporate Quality Assurance (CQA) and to do submissions after consent with Section Head.
To Train the subordinates on various aspects of Good Manufacturing Practice (GMP) etc.
To contribute team spirit & guide the team starting from preparation, planning & execution & till the preparation of validation report.
To include new concept in validation from new guidelines or from regulatory agency to improve the validation.
To keep the facility updated from GMP aspect as per regulatory expectation.
**Reasonable Accommodations**
**Recruitment Fraud Notice**
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