Assoc, Quality
Year Ahmedabad, Gujarat, India
Job Description
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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.
- 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 Supervisor regarding any non-conformity from planning and execution.
- To prepare monthly and annual calendars for various periodic qualification/validations & get it reviewed by Supervisor 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 Trackwise.
- 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 Supervisor 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 Supervisor.
- To attend trainings 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 Supervisor for review & approve.
- 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 occurred during the shift\'s validation activities through daily meeting.
- To review and approve the 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 for safety aspects and record hazard or any near miss in the provided portal.
- Any additional responsibility as assigned by the Supervisor.
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Job Detail
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Job IdJD3256638
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear