Validation Sme

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 dry-run 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 on-site
- Excellent English and Italian (spoken and written)

**Benefits**
- Broad range of activities, tasks, and projects
- Flexible working conditions
- 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

Is IT in your DNA?