Validation & Calibration Coordinator - Monza, Italia - Chaberton Italia srl

Chaberton Italia srl

Azienda verificata

Monza, Italia

2 settimane fa

Inviato da:

Piero Bianchi

Reclutatore di talenti per beBee

Descrizione

Chaberton Professionals is one of the recruiting divisions of
Chaberton Partners. We support client companies in the search and selection of middle and top management profiles. Our goal is to create success stories and enrich the talent pipeline within our client companies.

For a pharmaceutical company we are looking for a
Validation & Calibration Coordinator who will be responsible for planning, scheduling, and executing the validation activities in accordance with the Site Validation Master Plan and the site validation procedures.

Main Responsibilities

Coordinate validation and calibration activities and personnel involved;
Perform, coordinate and plan validation events in compliance with safety requirements, OSHA and EPA/DHEC requirements;
Ensure the validations compliance with ISO 13485 and all site applicable standards;
Manage Cleaning, Process, Equipment, Sterilization and Software validations and studies and relevant documentation;
Ensure that discrepancies and excursions are fully investigated within the preestablished turn around timeframe;
Investigate on nonconformances and manage CAPA related to Val & Cal activities;
Conduct gap assessments as needed;
Perform Risk Analysis according to ISO 1497
Evaluate and update procedures, policies, specifications and other regulated validation, qualification and commissioning.

SKILLS:

Degree in CTF, chemistry, biotechnology, pharmacy;
Deep knowledge of Medical Device/ISO standards and cGMP;
Lean Six Sigma and Green Belt certification preferable;
Computer System Validation experience
Knowledge of EtO sterilization process
Knowledge of GAMP standards as a plus
Deep Knowledge and use of statistical and excel software
Fluent English.

EXPERIENCE:

3/5 years of experience in Medical Device or API/Pharmaceutical industry

Contract Type:
Permanent

Contratto di lavoro:
Tempo pieno, Tempo indeterminato

Stipendio:
€35.000,00 - €45.000,00 all'anno

Benefit: