What are the responsibilities and job description for the Senior GCP Auditor position at Chiesi?
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas : AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CAR E (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi USA
Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.
What we offer
Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi."
Who we are looking for
Purpose
To assure the compliance and the correct application of Good Clinical Practice (GCP), inside the clinical development of the Global R&D projects in US, Latin America, and EU environments.
Main Responsibilities
- Execution of first party audits and Mock Inspections inside Global R&D departments.
- Execution of second party audits (remote and on-site) to Clinical Research Organizations (CRO), Clinical Laboratories, Trial Master Files, investigational sites, clinical service providers supporting clinical trials under US, ICH and EU requirements.
- Management of audit process starting from the agenda till the finalization of audit reports.
- Support Global R&D Departments and Global R&D QA Auditing, Due Diligence, Supplier Qualification Department in the management of findings (non-conformities) coming from audits.
- Support the responsible of the Unit Head in collecting information supporting the preparation of the annual audit program for GCP auditing activities.
- Support the monitoring and the updating of the annual audit program for GCP auditing activities.
- Finalization / review of SOPs relating to GCP auditing activities.
- Organization of training on GCP regulations / procedures under US, ICH and EU requirements.
Experience Required
Education
Minimum of Bachelor's degree in a scientific discipline required.
Languages
Proficiency in English required.
Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
