Req. now for the Tech, Metrology & Qualification

Job Description

Tech, Metrology & QualificationApply Now Save JobThis is where you save and sustain livesAt 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters 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.About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter s employees worldwide are building upon the company s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.Job Summary Job Title Tech Metrology & QualificationLocation Whitefield, Bangalore Shift General The Tech M&Q will work with the cross functional team, stake holders, Quality & vendors to carry out the Calibration & Maintenance activities as well as Qualifications in line with Quality Management Systems.In this role you are expected to maintain the lifecycle of instruments including the scheduling, maintenance & trouble shooting as per the calibration cycle.As Tech M&Q you are also expected to be part of the Qualifications both internal & external, play the role of Validation representative giving the inputs with respect to Metrology including the reviewing of documents.Should have good knowledge of Quality Management systemsJob Responsibilities:Calibration & Maintenance
• Expertise in Calibration & maintenance wrt to various equipments & Instruments in terms of Medical devices, R&D, Pharma.
• Expected to be technically strong in terms of carrying out 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 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.
• Basic knowledge on environmental monitoring system.
Qualification & Validations
• To be well versed & have hands on experience in end to end qualification process ( inhouse & external).
• To be able to review & provide technical inputs for the QP, IQ,OQ,PQ & DQ.
• Supporting the users/instrument owners for Qualification & Validations for new installation of laboratory instruments.
Environmental Monitoring ( EMS )
• Should be familiarized with the Operation & Maintenance of EMS including troubleshooting.
• Should be experienced in Temperature Mapping.
Other requirements
• Should possess strong skills in terms of writing, reviewing & approving GMP documents such as protocols, tests, SOPs.
• 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
• Strong awareness & experience required in GMP, GDP, DI, GLP ( GxP), 21 CFR part 11 compliance.
• Should have good experience in terms of external & internal audits.
• Should know MS-Office tools, software tools such as blue mountain, Trackwise.
• Should know the PR/PO & vendor registration process.
Educational & Experience
• Experience of 6 8 years, educational background preferably BE - Instrumentation or Electronics & instrumentation.
• Relevant certifications would be a plus.
• Good soft skills, communication skills including fluency in English writing, speaking & communication.
Equal Employment OpportunityBaxter 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, disability/handicap status or any other legally protected characteristic.Reasonable AccommodationsRecruitment 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 .,

Keyskills :
new installationpharmacy automationroot cause analysisms office toolsmaintenance activitiesquality managementregulatory requirements