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:

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• 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

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✅ Qualifications and Requirements:

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• 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)

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Technical Skills:

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• Proficiency in Microsoft Office Suite (Excel, Word, Outlook)

 

Organizational Skills:

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• Strong planning and time management skills, with the ability to meet deadlines and optimize resources

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Interpersonal Skills:

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• Team-oriented with strong communication skills to foster a positive and productive work environment

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Analytical Skills:

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• Logical thinking and problem-solving abilities using a structured and methodical approach

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Prioritization:

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• Ability to identify and focus on critical objectives while adapting to changing business needs

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✅ 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