Job
Description
Summary The Qualification Expert for Analytical Instrumentation is responsible for ensuring the accuracy and reliability of analytical instrumentation used in various scientific processes. They will be responsible for assessing and verifying the qualifications of these instruments, as well as documenting and maintaining the records. About the Role Major accountabilities: Perform qualification assessments on analytical instruments to ensure compliance with regulatory requirements and industry standards. Develop and execute qualification protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for analytical instruments. Collaborate with cross-functional teams to ensure alignment on qualification processes and requirements. Ensure that all qualification activities are properly documented and maintained in accordance with company policies. Troubleshoot any issues or discrepancies that arise during qualification and propose and implement appropriate corrective actions. Stay up to date with industry trends, regulations, and best practices related to analytical instrumentation qualifications, and incorporate them into the qualification processes as necessary. Provide technical expertise and support to internal teams relating to the qualification and maintenance of analytical instruments. Continuously improve the qualification processes to enhance efficiency, accuracy, and compliance. Key performance indicators: Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks. Feedback from other team members/leaders. Refer to annual individual and team objective setting. Measurable contributions to increasing efficiency and productivity in the work related to assigned projects. Minimum Requirements: B.E./B.Tech/Bachelor's or master’s degree in chemistry, Analytical Chemistry, or a related field with experience of 10 + years. Solid understanding of analytical instrumentation principles and technologies. Proven experience in qualifying and validating analytical instruments Like HPLC, GC , UV, FTIR, KFT, Balances, etc, including the development and execution of qualification protocols. Sound Knowledge on Software validation, software operation of CDS like Empower, Chromeleon, etc. Knowledge of relevant regulatory requirements and standards, such as FDA regulations and GMP guidelines. Strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues related to instrumentation qualification. Excellent documentation and record-keeping abilities, with strict attention to detail. Effective communication and interpersonal skills, with the ability to collaborate and liaise with cross-functional teams. Ability to work independently and prioritize tasks in a fast-paced environment. Skills: Laboratory Equipment. Laboratory equipment qualification GMP. Sop (Standard Operating Procedure). Technical Writing. Languages : English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards Division Development Business Unit Innovative Medicines Location India Site Telangana Company / Legal Entity IN10 (FCRS = IN010) Novartis Healthcare Private Limited Functional Area Research & Development Job Type Full time Employment Type Regular Shift Work No Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
