18 set - Parma
Chiesi Group
Who we are looking for
This is what you will do
The Global R&D; QA, Senior Validation, Digital & Data Integrity Specialist ensures the maintenance in a state of control and validation of software systems involved in GXP process. Ensures Project Management for relevant projects.
You will be responsible for
- Coordination and supervision of the validation of computerized systems, particularly considering the impact of new digital technologies in the GxP environment (Validation Manager for Computerized Systems).
- Drafting validation procedures, validation plans (VPP), related summaries (VSR), and periodic validation reviews (PVR) in the software domain.
- Reviewing and approving, in the software domain: URS, functional specifications, qualification reports, and software procedures.
- Managing changes, deviations, and CAPAs related to software systems.
- Participating as a Technical Expert, with regard to validation aspects, in internal and external audits, including audits of software suppliers and especially clinical service providers, and supporting the related follow-up.
- Promoting adequate awareness among personnel involved in the use of software systems regarding CSV and Data Integrity aspects.
- Conducting and supporting training related to procedures and regulations connected to software validation and Data Integrity topics.
- Reviewing or approving SOPs related to software systems in accordance with regulations and company procedures.
- Supporting risk phases as Risk Coordinator for software quality aspects (drafting or reviewing Risk Assessment Reports, reviewing Risk Management Reports, Risk Review Reports).
- Acting as the CSV point of contact during authority inspections.
- Supporting the collection and assessment of QMS KPIs for the proper area
You will need to have
- At least 5 years of experience in validation of computerized systems (CSV) in the pharmaceutical industry
- Excellent knowledge of all activities necessary for Computer Systems Validatio
18 set - Chiavari
Acrobatica
18 set - Fonzaso
Greta
18 set - Trento
Car Clinic
18 set - Nola
Demetra Formazione