Equipement Validation Specialist Consultant - Ivrea Torino

Equipement Validation Specialist Consultant - Ivrea
Torino
Piemonte, Torino

Tasks and Responsibilities

- Act as a Subject Matter Expert in the process validation project of our client

- Define the qualification framework in the process validation, review supplier documentation, create qualification deliverables and validation plans

- Complete risk assessment, reporting

- Analyze and evaluate process data from executed validation studies.

- Support the Quality team in all validation topics

- Have a good understanding of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP

Consulente Sponsor Dedicated|Esperienza nel settore Healthcare

**Profile Requirements Must-Have**:

- Experienced (Mid-Level to Senior Level) Qualification / Validation SME

- Working and process knowledge of lab equipment qualification; Quality Control equipment qualification and production equipment qualification including, but not limited to Airsampler, Glove Tester, Leak Tester, Dose Calibrator etc.

- Leading equipment qualification activities as responsible QM / QC

- Performing and documenting functional as well as performance / user acceptance testing (OQ / PQ / UAT)

- Extracting configuration information from the equipment & perform dry-run tests for IQ / OQ / PQ

- GxP & Data Integrity working knowledge

- Good Documentation Practises in regulated pharmaceutical environment

- Languages - Italian; English (business English)

- Available to work on-site from the customers office in Ivrea

- Good communication skills and proactive approach to manage activities and workload (independently) - to ensure engagement of the customers resources on-site

**Profile Requirements Nice-To-Have

- Experience with authoring / writing qualification deliverables such as e. g.

User Requirements Specifications, Risk Assessments, Configuration Specifications, IQ / OQ as well as PQ / UAT Test Specifications

- Experience with authoring / writing Business Standard Operating Procedures (SOP's) required to maintain the qualified state of the equipment - including, but not limited to Equipment usage, Audit Trail Reviews, User Access Management etc.

- Experience with authoring / writing Training Material (equipment & business process

**IT** and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA

- Broad range of activities, tasks, and projects

- Flexible working conditions

- 20 days of PTO

- Fishing for Friends program - our referral program

- Refreshments in the D-ploy office

- Further development and professional advancement

- Friendly and international working environment

- Company-sponsored events

- Competitive salary and various benefits

For an **IT** and Engineering Solutions company we are looking for a Validation SME