Research Assoc I, Product Quality

Job Description

Research Assoc I, Product QualityApply NowSave 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.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 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.
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 lab condition like temperature, RH
• Should be familiarized with the Operation & Maintenance 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, 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 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.
Educational & Experience
• Experience of approx. 8 - 10 years, educational background preferably Pharma or instrumentation postgraduate having good experience on instrumentation and its related investigation handling ability.
• Relevant certifications would be a plus.
• Should have an experience as a supervisor & managed teams/team member.
• Should be fluent in English - communication, Speaking & writing.
Reasonable AccommodationsBaxter 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 Americas_TTA@baxter.com 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 Recruitment Fraud Notice . 101741Apply Now Save Job,

Keyskills :
soft skillsroot causems office toolsroot cause analysistest scripts