Global R&D QA, Senior Validation, Digital & Data Integrity Specialist (Parma, IT)

Biopharma Careers; Parma; In loco; EUR 47.000 - 57.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation support

Remote work options

Tax assistance for foreigners

Descrizione del lavoro

Chiesi in Parma, Italy, seeks a Global R&D QA, Senior Validation, Digital & Data Integrity Specialist to maintain validated software systems in a GxP context and support related audits.

You will lead computerized system validation, draft plans and reviews, and ensure data integrity across regulatory requirements. The role includes training, risk management tasks, and collaboration with internal teams.

Competenze

• At least 5 years of experience validating computerized systems (CSV) in the pharmaceutical industry.
• Excellent knowledge of all activities necessary for Computer Systems Validation.
• Strong knowledge of CFR 21 Part 11, EU GMP Annex 11, MHRA, WHO; ICH E6, GAMP5.
• Excellent understanding of Data Integrity principles.
• Good knowledge of Risk Management techniques.

Mansioni

• Coordinate and supervise validation of computerized systems (CSV) in the GxP environment.
• Draft validation plans (VPP), summaries (VSR), and periodic validation reviews (PVR).
• Review URS, functional specs, qualification reports, and software procedures.
• Manage changes, deviations, and CAPAs related to software systems.
• Participate as a Technical Expert in audits, including supplier and clinical service provider audits.
• Promote awareness of CSV and Data Integrity among personnel.
• Conduct and support training related to software validation and Data Integrity topics.
• Review or approve SOPs related to software systems.
• Support Risk Coordinator activities for software quality (risk reports).
• Act as the CSV point of contact during authority inspections.
• Assist in collecting and assessing QMS KPIs.

Conoscenze

CSV validation

Data Integrity

Regulatory knowledge

Risk management

Quality systems

English fluency

Descrizione del lavoro

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.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

Who we are looking for

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.

Benefits

• In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
• We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support.
• We provide flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive.

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.

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.