R&D Analyst
hace 1 semana
Perform tests for finish products, APIs, excipients, stress degradation, stability, pre-stability, trials, reference product and GMP batches. Perform development, validation and verification of analytical methods. Control and identify the samples in the chamber and in the laboratory. Report the results and evaluate them with the specification.
ResponsibilitiesSpecific Responsibilities
- Assign any sample with an ID according to the SOP to ensure sample traceability.
- Perform tests in developing, verify and validate analytical methods for API, excipients and Pharmaceutical Product Development R&D.
- Register the analytical results of the tests and produce reports with the results and conclusions.
- Inform the Analytical Development Scientist about the results obtained, and any incident occurring during the analysis.
- Propose changes and / or variations in analytical tests carried out to improve methodologies.
- Inform, investigate and document OOS and OOT in a timely manner.
- Calibrate if applicable and maintain R&D as per specific SOP. Review and maintain stock levels of materials, consumables, reagents (standard and other products).
- Advise, train, support and verify the work done by other analysts to ensure a good functioning and success of the department.
- Train the new incorporations in the specific activities and functions of the position in which you are an expert.
Requirements and personal skills
- Education: Basic Studies in Chemical Analysis.
- Languages: High level of Spanish and medium level of English.
- Experience (years / area): Minimum 1-4 years' experience in the functions mentioned above as analyst in the pharma industry, working with drugs. Handling Equipment of Liquid Chromatography. Knowledge in other analytical techniques.
- Specific Knowledge: GMP regulations.
- Travels: Not required.
- Personal skills: Analytical skills, reliability and patience.
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