Podsumowanie
About the Role
Key Responsibilities
- Responsible for performing method feasibilities and validation of robust analytical methodologies applied to innovative oral solid dosage forms. Strong experience in chromatography techniques and experience in handling techniques like Dissolution, Titrator etc., used for OSD testing is a pre-requisite.
- Plan, organize, execute, and document scientific experiments (e.g., analytical method developments/ validations/ transfers/ stability/ release testing, formulation development analytics etc.) according to the agreed timelines and appropriate quality standards.
- Accountable for documentation and submission of raw data in an appropriate data system (for e.g., LIMS test activation and results entry).
- Responsible for good documentation practices (GDP) and good laboratory practices (GLP) during execution of laboratory activities.
- Generate and support in evaluation and interpretation of results including investigations on SST failures, OOX/Deviations/Change controls as needed.
- Responsible for assigned laboratory related area/activities (e.g., chemical/reagents/consumables/samples/column/ glassware management etc.). Responsible for implementation and maintenance of lean/efficient/environmentally sustainable practices in the laboratory.
- Proactively communicate key issues and any other critical topics in a timely manner to the manager and/or to any other relevant project team member(s).
- Responsible to meet KQI (Key quality indicators) and KPI (Key performance indicators) for all assigned activities. Support internal and external audits and ensure no critical findings within the assigned scope.
Essential Requirements:
- Strong expertise in Chromatography and Dissolution Testing, including method selection and handling
- Proven experience in Analytical Method Development, Validation, and Transfer and multimedia dissolution
- Expertise in method validation, method transfer, IcH guideline, HPLC and UPLC.
- Solid understanding of Regulatory Compliance and GLP standards
- M.Pharm./M.Sc. with 4 -8 years of relevant experience, with demonstrated experience in a related domain.
Desirable Requirements:
- Understanding digital tools
- Hands on experience with GLIMS, Chromeleon and ELN
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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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.
