GCP specialist R&D Auditing Department - Temporary (Parma, IT)

Biopharma Careers; Parma; Ibrido; EUR 35.000 - 43.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus scheme

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Descrizione del lavoro

Chiesi Research & Development in Parma is seeking a Quality Assurance professional to verify and ensure GCP compliance across CAPAs, audits, and QA documentation. You'll manage quality metrics and support audits within Global R&D.

Based at the Parma HQ with a flexible hybrid working arrangement, you will collaborate with external consultants and internal teams, write SOPs, and ensure traceability and regulatory compliance throughout clinical trials.

Competenze

• At least 1 year in Pharmaceutical, Consultancy or CRO QA with GCP knowledge for clinical trials.
• Knowledge of GCP requirements and quality systems.
• Experience with pharmaceutical development processes for clinical trials.
• English language proficiency.

Mansioni

• Manage GCP CAPAs and quality metrics supporting compliance.
• Prepare and review quality documents and SOPs for audit readiness.
• Execute first and second party audits and track audit findings.
• Support external consultants and qualification workflows.
• Maintain training and ensure traceability of records.

Conoscenze

GCP compliance

Quality Assurance

Audit management

SOP writing

Training

English proficiency

Formazione

Scientific degree

Strumenti

TrackWise

Audit software

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.

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.

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

This is what you will do

To verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution of first and second party audits.

You will be responsible for

• Management of CAPA Plans from GCP audits
• Management of the requests for the collection of quality metrics, KPIs supporting Global R&D Departments
• Management of Trackwise, Suppliers and Audit workflows
• Support the management of external consultants supporting the Auditing & Supplier Qualification Unit.
• Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.
• Write/Review SOPs relating to audit and qualification of clinical service providers
• Ensure training on relevant activities and procedures
• Ensure good documentation and traceability
• Execution of GCP first and second party audits
• Finalization and management of the GCP audit reports

You will need to have

• At least 1 year of experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with knowledge of GCP supporting clinical trials and knowledge of compliance
• Knowledge of GCP requirements and quality system
• Knowledge of the pharmaceutical development process supporting clinical trials
• Knowledge of training technique
• Scientific degree
• Good knowledge of English.

We would prefer for you to have

• Knowledge of auditing technique to be considered an added value
• ISO auditor Certification to be considered an added value

Location

The position is based at our headquarters in Parma and offers a flexible hybrid working arrangement.

Compensation Range

The minimum salary for this role is € 39.000, 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 and more.

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.

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