Validation Sme - Zaragoza, España - D-ploy

D-ploy

Empresa verificada

Zaragoza, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

D-ploy is an
IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.

We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients.

By building relationships and trusted partnerships within the
IT community, we optimize our customer's
IT productivity and contribute to the organization's success and value.

We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization.

We are focused on creating value where
IT counts, join us

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

Requirements:

Experienced 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 dryrun tests for IQ / OQ / PQ
GxP & Data Integrity working knowledge
Good Documentation Practices in regulated pharmaceutical environment
Good communication skills and proactive approach to manage activities and workload (independently) to ensure engagement of the customers resources onsite
Excellent English and Italian (spoken and written)

Benefits