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Validation & Calibration Coordinator

2 settimane fa

Monza, Italia Chaberton Italia srl A tempo pieno

**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 pre-established 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 14971
- 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:

- Mensa aziendale

Orario:

- Dal lunedì al venerdì

Tipi di retribuzione supplementare:

- Premio di produzione
- Quattordicesima
- Tredicesima