Summary
About the Role
Your responsibilities include, but are not limited to:
- 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.
WHAT YOU’LL BRING TO THE ROLE:
- 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.
- Continuous learning mindset and willingness to stay updated with industry advancements.Good knowledge of current Good Manufacturing Practices (cGMP) ;Advanced scientific/technical writing skills Wide experience on de-formulation studies of the drug products , especially in the microscopic evaluation of drug component.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
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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
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.
