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. To supervise departmental activities, resources, facility, and equipment\'s/instrument\'s/aids related to Document Control (DC), Batch Release (BR) and Retain Sample (RS) management on day to day basis and to communicate the challenges, updates, compliance levels to Quality Assurance Head. 2. To provide planning (day to day/Weekly/Monthly) to the team members to discharge day to day activities in Document Control (DC), Batch Release (BR) and Retain Sample (RS) functions to oversee and ensure the activities are completed timely, and in compliant manner. 3. To be interface between the cross functional departments to confirm normal functioning of Document Control (DC), Batch Release (BR) and Retain Sample (RS) management program and to collaborate within and outside the functional departments to maintain the SLA\'s associated with each sub functions. Primarily responsible to drive the compliance to the different geographical regulations, internal policies and Standard operating procedures. 4. Responsible to drive the continuous improvement plans with Quality Assurance Head and cross functional partners, and to ensure all time readiness of the facility in response to the regulatory Inspections. 5. Responsible to ensure right persons at right jobs are allotted followed by assuring the staff are adequately trained and qualified to conduct necessary discharge of their duties / responsibilities followed by ensuring the team is in continued state of being trained. 6. To Ensure review and approve Batch Manufacturing Record, Batch Packing Record and SOPs and to provide necessary inputs to remain compliant. Also, to review the BMR\'s and BPR\'s based on requirement. 7. To review weekly, monthly manufacturing & dispatch plan & ensure flawless implementation of the plan in co-ordination with cross functions department to ensure business goals are met with compliance. 8. To drive periodic meetings with department to assess / monitor the health of subfunctions and report / update / escalate the outcome / challenges to Quality Assurance Head. To drive effective investigation of Non-compliance (NCR) by providing inputs, and conclude the investigations effectively along with timely implementation of CAPA to ensure effective actions are taken to improve the systems. 10. To provide response to queries from Regulators/Regulatory Bodies, Internal and external customers and seek necessary support to efficiently handle and response and provide necessary information to QA Head. 11. To ensure functional changes are implemented timely followed by timely closure of actions. 12. To facilitate and manage internal and external inspections / Audits and to lead the inspection/audit for functions directly responsible, and to support the Quality Assurance head in conducting fair and efficient inspections/Audits. 13. To escalate and assist departmental head to ensure safe and quality products are manufactured and supplied. 14. To conduct necessary escalations and to be vital in decisions by recommending / assisting Operations Head, Quality Assurance Head, or QMR or Plant Manager. To escalate any possible / potential breach / departures critical to the product, properties, or facility. 15. To Ensure end to end process of retain sample management, which include ensuring the facility of storage in state operation for intended usage, qualification, and necessary modification. 16. To prepare budget for purchase of all the requirements related to department / Function. 17. To seek area of improvement from QA Head and implement action plan. To provide inputs and necessary information / documents / trends and recommendations to Quality Assurance Head to maintain compliance levels and upgradation of the system to relevant or revised standards. 18. To drive effectiveness programs that is driven through corporate, Site or function. 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 . 107571

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