descripción del trabajo

The job purpose is to develop and apply analytical methods to detect impurities in final products and drug substances while ensuring regulatory compliance, data integrity, and adherence to health and safety regulations in the laboratory. Responsibilities include reviewing and approving documents, managing investigations of unexpected situations, coordinating equipment maintenance and calibration/qualification activities as well as analytical method validation/transfer activities. Additionally, the role involves participating in audits and establishing effective internal and external communication. Your responsibilities will includen (and not be limited to): • Reviewing and/or approving all documents following analytical method development (analytical method). • Preparing, updating and/or reviewing department procedures. • Ensuring and monitoring laboratory operations in accordance with ALCOA+ and data integrity principles. • Controlling and ensuring investigation and root cause analysis of unexpected situations (OOX- Deviation- TTI). Responsible for implementing preventive and corrective actions. • Coordinating validation activities, including reviewing, and approving analytical protocols and reports for validation and/or transfer of analytical methods. • Researching, acquiring knowledge, and applying it to define the strategy for developing analytical methods to accurately detect trace amounts of impurities in final products and drug substances. • Being proactive in providing technical responses to other departments or CoEs. • Taking an active role in escalation processes and related actions. • Taking responsibility for audit preparations and subsequent actions. • Responsible for preparation of audit documents and following up audit outcomes and actions. • Preparation of regulatory submission documents. • Coordinating equipment-related activities such as periodic preventive maintenance and requalification, calibration, and verifications. Monitoring the annual plan and reviewing and/or approving related documentation for all these activities. • Ensuring proper management of technical incidents/failures of laboratory equipment. • Evaluating and implementing new instruments and systems. • Change control coordinator/owner. • Establishing effective internal and external communication. • Ensuring compliance with HSE rules applicable in the laboratory. • Keeping required training up to date, including data integrity training. • Participating in occasionally necessary tasks as requested by the direct manager. Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Education: Grade in Chemistry, Pharmacy, Biotechnology or similar. Desirable education: Master o PhD. in chromatographic techniques and mass spectrometry. Fluent Spanish and English Experiences: Experience in liquid chromatography and mass spectrometry, working in GxP environment.