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. Job Summary . Job Title - Metrology & Qualification, Associate Manager . Location - ARD, Ahmedabad . Shift - General or as per requirement The Supervisor III M&Q will lead the team of metrology and qualifications and will work with the cross functional team, stake holders, Quality & vendors to monitor the Calibration & Maintenance activities as well as Qualifications in line with Quality Management Systems. In this role you are expected to maintain, review, and approve the lifecycle of instruments including the scheduling, maintenance & trouble shooting as per the calibration cycle. As Supervisor III M&Q you are also expected to ensure that the Qualifications both internal & external will perform as per Baxter system, supervise the role of Validation representative giving the inputs with respect to Metrology including the reviewing and approving of documents. Should have good knowledge of Quality Management systems. Should have managed a team & possess Managerial skills Should be a versatile profile with a deep technical understanding of Calibration Qualification & Quality. Should lead a failure investigation as per procedure. Job Responsibilities: Calibration & Maintenance Expertise in Calibration & maintenance wrt to various equipment\'s & Instruments in terms of Analytical, formulation and engineering of R&D, Pharma. Expected to be technically strong in terms of reviewing and approving the calibrations & maintenance as well as supervise the same with 3rd party vendors. Well aware of the National Standards, NABL requirements, Regulatory requirements in terms of Calibration & Maintenance. Should be well aware of ISO13485 & 172085 in terms of applicability wrt to Metrology. End to end handling of the calibration & maintenance lifecycle & should be well versed to supervise the use the electronic platforms for the same including troubleshooting. Vendor management - to interact with the suppliers & third parties for completion of calibration activities within the scheduled timelines. Proactive in organizing the activities as per the schedule by coordinating with stakeholders as well as vendors. Budgeting & optimizing the Calibration & Maintenance costs. Working on the CAPEX projects & driving the continuous improvement initiatives. Qualification & Validations To be well versed & have hands on experience in end to end qualification process. To be able to review & provide technical inputs for the QP, IQ,OQ,PQ & DQ. To be able to write the test scripts for the qualifications if required. To be a part of the CSV for supporting the IT team Environmental Monitoring ( EMS ) wrt temperature and RH monitoring and controlling Should be familiarized with the Operation & Maintenance of EMS. Should be able to work on the specific EMS platform to provide necessary reports or resolve queries in terms of EMS. Should have a troubleshooting knowledge on EMS. Should be experienced in Temperature Mapping. Other requirements Should possess strong skills in terms of writing, reviewing & approving GMP documents such as protocols, tests, SOP\'s. Should be well versed with Quality requirements such as NCR & CAPA management with investigations & root cause analysis knowledge, Change Management ( would be an advantage if knows Trackwise tool). Should be able to manage the team as well as vendors & stakeholders Should be well aware of the supplier Quality processes & the requirements wrt to SLA & MSA\'s. Strong awareness & experience required in GMP, GDP, DI, GLP ( GxP), 21 CFR part 11 compliance. Should know how to perform vendor audits. Should be aware of managing Projects. Strong team player, interpersonal, soft skills, communication & organizational skills required. Should know MS-Office tools, Track wise, Blue Mountain (or similar calibration software platform) Should have problem solving capabilities & solutions based approach. Should be able to think out of box & come up with alternatives while handling any issues. Should have good networking skills (with own team members, vendors & cross functional teams ). Should be able to face & be the front face in the audits - internal & external. Should be able to identify the issues & gaps & work towards continual improvement. Should know the PR/PO & vendor registration process. Educational & Experience Experience of 14 - 17 years , educational background preferably Pharmaceutical post graduate or instrumentation post graduate. Relevant certifications such as 6 Sigma, Operational excellence, Auditor certifications, ISO certifications, Lean would be a plus Should have an experience as a supervisor & managed teams/team member. Should have mentoring & Coaching skills. Should have good Managerial skills including soft, interpersonal, organizational skills. Should be fluent in English - communication, Speaking & writing. Should possess good presentation skills. 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 . 103950

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