Global R&D QA, Senior Validation, Digital & Data Integrity Specialist

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 Validation
• Good knowledge of European and U.S. quality regulations and main pharmaceutical industry guidelines (CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO; ICH E6, GAMP5 Second Edition)
• Excellent understanding of Data Integrity principles
• Good knowledge of Risk Management techniques
• Fluent English

We would prefer for you to have

• Experience in CSV in clinical development and knowledge of ICH E6 are strongly preferred

Location

Parma, Italy

Compensation Range

The minimum salary for this role is € 52.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations.

This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.

In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.

What we offer

No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way.

We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.