Quality Assurance (GCP)
📍 Work Location: Mesagne (BR), Italy
🕒 Working Hours: Full-time
📅 Contract: Fixed-term (maternity leave coverage), with the possibility of permanent employment
💼 Position Description:
Due to the upcoming increase in clinical trial quality assurance projects, we are planning to strengthen our Quality Assurance Department. We are therefore looking for a candidate to support ClinOpsHub’s Quality Assurance Consultants in managing departmental projects, in compliance with company SOPs, guidelines, and national and international regulations.
📝 Key Responsibilities:
-
Ensure systems and processes are compliant with GCP guidelines
-
Draft and/or revise SOPs
-
Manage non-conformities and CAPAs
-
Promote continuous improvement of the quality management system
-
Oversee the selection and qualification of company vendors
-
Maintain the internal quality system to ensure compliance with applicable procedures, guidelines, and regulations
-
Report significant quality deficiencies and/or risks to upper management and actively participate in problem resolution
-
Attend inspections by regulatory authorities and external audits (client or ISO 9001:2015 auditors)
-
Perform quality checks on study documentation (e.g., ISF at clinical sites and TMF at sponsor level), including study protocols, Investigator’s Brochures, informed consent forms, CRFs, etc.
-
Support company auditors in the preparation and management of system and study-specific audits to ensure compliance with sponsor protocols, GCP, industry guidelines, and clinical trial regulations
-
Act as a Quality Assurance Consultant for clinical sites, laboratories, sponsors, and CROs—clients of ClinOpsHub—providing QA consulting remotely and/or on-site as per agreed terms
✅ Qualifications and Requirements:
-
Education: Second-level degree in a scientific field (preferably a Master’s/Ph.D. in Biology, Biotechnology, Pharmacy/Pharmaceutical Chemistry and Technology, Life Sciences, etc.)
-
Certification: Qualification as a GCP QA professional in accordance with Article 3 of the Ministerial Decree of 15.11.2011 (Minimum requirements for Contract Research Organizations involved in clinical trials of medicinal products)
Technical Skills:
-
Proficiency in Microsoft Office Suite (Excel, Word, Outlook)
Organizational Skills:
-
Strong planning and time management skills, with the ability to meet deadlines and optimize resources
Interpersonal Skills:
-
Team-oriented with strong communication skills to foster a positive and productive work environment
Analytical Skills:
-
Logical thinking and problem-solving abilities using a structured and methodical approach
Prioritization:
-
Ability to identify and focus on critical objectives while adapting to changing business needs
✅ Language: Excellent command of English
✅ Experience: Minimum of 1 year of relevant experience; prior experience as QA in Phase I studies is preferred
📩 How to Apply:
Send your CV and a brief motivational letter telling us about yourself, what you're looking for, and your professional motivations and aspirations to: cv@clinopshub.com