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:
SANDOZ
Business Unit:
Quality STO
Country:
Spain
Work Location:
Barcelona Palafolls
Company/Legal Entity:
Sandoz Industrial Product
Functional Area:
Quality
Job Type:
Full Time
Employment Type:
Regular
Shift Work:
No
Early Talent:
Yes
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