- 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
- Knowledge of GCP requirements and quality system
- Knowledge of the pharmaceutical development process supporting clinical trials
- Knowledge of training technique
- Knowledge of auditing technique to be considered an added value
- Planning and organizational skills
- Strategic thinking
- Team working
- Quality orientation
- Communication skills
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GCP Compliance Specialist - Parma, Italia - Chiesi Group
Descrizione
Who we are looking for
Purpose
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.
Main Responsibilities
Experience Required
At least 3 years' experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development environment Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance.
ISO auditor Certification to be considered an added value
Education
Scientific degree
Languages
Good knowledge of English
Technical Skills
Soft Skills
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
