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

Chiesi; Parma; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descrizione del lavoro

Chiesi is seeking a Senior Validation Specialist to lead validation of computerized systems (CSV) in Parma. You will manage projects, coordinate software validation activities, and support audits of software suppliers within a GxP environment.

The role requires 5+ years in CSV, deep knowledge of CFR 21 Part 11 and EU GMP Annex 11, and strong Data Integrity and risk management skills. Fluent English and remote work options may be considered for exceptional candidates.

Competenze

• 5+ years in validation of computerized systems (CSV) in pharma or biotech.
• Strong knowledge of CFR 21 Part 11, EU GMP Annex 11, ICH guidelines.
• Excellent understanding of Data Integrity concepts and risk-based validation.

Mansioni

• Manage project for validation of computerized systems (CSV) in GxP environment.
• Coordinate validation of software, including URS, IQ/OQ/PQ, and associated documentation.
• Lead audits of software suppliers and clinical service providers and manage CAPAs.
• Promote CSV and Data Integrity awareness among staff and train on procedures.

Conoscenze

CSV validation

Regulatory compliance

Data integrity

Risk management

Audits & inspections

GxP knowledge

Strumenti

URS review

IQ/OQ/PQ

VPP/VSR

CFR 21 Part 11

Descrizione del lavoro

Global R&D QA, Senior Validation, Digital & Data Integrity Specialist Chiesi • Parma, Emilia-Romagna, IT

About us

Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

Who we are looking for

• Ensures Project Management for relevant projects.
• 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.

Compensation and benefits

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.

• pension
• private medical insurance
• wellbeing programme
• flexible benefits programme

We provide top‑class benefits, including comprehensive healthcare programmes, 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.

Location

Parma, Italy

Equal opportunity employer

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.