Nitrosamine Coe Expert | Hor767

Responsibilities:Reviewing and/or approving all documents following analytical method development.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.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.Minimum Requirements:Education: Grade in Chemistry, Pharmacy, Biotechnology, or similar. Desirable education: Master o PhD. in chromatographic techniques and mass spectrometry.Fluent in Spanish and English.Experiences: Experience in liquid chromatography and mass spectrometry, working in GxP environment.Division:SANDOZBusiness Unit:Quality STOCountry:SpainWork Location:Barcelona PalafollsCompany/Legal Entity:Sandoz Industrial ProductFunctional Area:QualityJob Type:Full TimeEmployment Type:RegularShift Work:NoEarly Talent:Yes#J-18808-Ljbffr