Nitrosamine Coe Expert - Palafolls, España - Sandoz

Sandoz

Empresa verificada

Palafolls, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Job ID BR- 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 equipmentrelated 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