Nitrosamine Coe Expert

Job ID- 377801BR- Jun 28, 2023- Spain**Job Description**:

- 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.
- 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._

**Minimum Requirements**:

- 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.

Division

SANDOZ

Business Unit

Quality STO

Location

Spain

Site

Barcelona Palafolls

Company / Legal Entity

Sandoz Industrial Product

Functional Area

Quality

Job Type

Full Time

Employment Type

Regular

Shift Work

No