Quality Assurance Expert - Computerized Systems (M/F)

Gi Group Consulting is an international consulting group, reporting a turnover of €2.84 million and a growth rate of 25%. As a family-owned company specializing in talent placement within the healthcare industry, we place human values at the heart of our mission. We leverage our expertise in Life Sciences to serve our clients: pharmaceutical companies, CROs, and biotech firms.

We are recruiting in Saclay a Quality Assurance Expert - Computerized Systems (M/F) for a mission within a prestigious pharmaceutical group starting in June 2025. Our client is an international pharmaceutical laboratory committed to therapeutic progress for the benefit of patients, in collaboration with healthcare professionals. Its growth is based on a constant search for innovation across multiple therapeutic areas.

We are looking for a dedicated and detail-oriented professional with extensive experience in Computerized Systems Validation within Clinical Development, Pharmacovigilance, and Regulatory Affairs. Seeking to leverage expertise in ensuring compliance with GxP, GAMP 5, and 21 CFR Part 11 standards. Committed to implementing risk-based validation strategies, overseeing outsourced activities, and providing guidance on validation management.

Responsabilities

• Ensure Computerized System Validation is performed in compliance with corporate policy and procedures, and regulatory GxP requirements. In particular, define validation strategies, review ongoing or existing documentation, and ensure correct management of dysfunctions.
• Implement and maintain computerized systems compliance according to applicable standards.
• Lead the computerized system validation strategy following a risk-based approach taking into consideration the potential of the system to affect human subject safety and data protection, product quality and reliability of results,
• Ensure oversight of outsourced validation activities: define tasks/activities to subcontract, review/approve key validation deliverables and ensure compliance with Servier procedures and guidelines during the execution of validation activities,
• Advise, guide, support the concerned structures in the overall management of computerized system validation,
• Perform training of staff members on computerized system validation,
• Conduct computerized system initial risk assessments and periodic reviews,
• Participate in audit of IT systems and suppliers, as well as in preparation of and replies to inspections,
• Ensure the implementation of Corrective Actions & Preventive Actions (CAPA), if any,
• Assess the impact of upcoming regulatory changes on the computerized systems and validation practices.

Profile

• At least 3 years of experience in Computerized Systems Validation within the pharmaceutical and clinical research sectors.
• Master’s degree in Life Sciences, Pharmaceutical Sciences, or a related field.
• Exceptional analytical and problem-solving abilities, enabling the candidate to conduct thorough risk assessments and develop effective validation strategies that align with regulatory requirements.
• Possesses excellent verbal and written communication skills, facilitating clear and concise interactions with cross-functional teams, stakeholders, and regulatory bodies, while also being adept at training and mentoring staff.
• Demonstrates strong interpersonal skills and a collaborative mindset, fostering positive working relationships across departments and ensuring a cohesive approach to compliance and validation efforts within the organization.

Are you looking to be part of a vibrant and ambitious team?

Does this position resonate with your skills and aspirations?

If so, we’d love to hear from you—don’t wait, apply today!