Analyste CSV

Internetwork Expert; Dreux; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A healthcare company is seeking a CSV Analyst in Dreux, responsible for supporting and improving computer validation strategies, ensuring regulatory compliance, and collaborating with project teams. Ideal candidates will have a Bachelor’s degree and at least 2 years of experience in validation of computerized systems, with strong communication and technical skills.

Qualifications

• 2+ years of experience in the validation and qualification of complex computerized systems.
• In-depth knowledge of cGMP regulations.
• Good written and verbal communication skills.

Responsabilités

• Assist in the continuous improvement and implementation of global computer validation strategy.
• Develop, review, and approve CSV policies and procedures.
• Support business functions in the periodic review of systems.

Connaissances

Communication skills

Proactive approach

Knowledge of cGMP regulations

Risk assessment

Formation

Bachelor’s degree

Outils

Microsoft Office

ERP systems

LIMS

HRIS

Description du poste

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.

We have an exciting opportunity for a CSV Analyst to join Norgine in Dreux, France.

Principal Responsibilities

• Assist the Principal Process CSV Analyst in the continuous improvement and implementation of the global computer validation strategy and approach, taking into account relevant GxP requirements (e.g. EU Annex 11, FDA 21 CFR Part 11, Part 820, etc.) and other relevant regulatory requirements.
• Support the continuous improvement of appropriate procedures for the validation of computerized systems:
• Develop, review, and approve CSV policies, procedures, plans, and protocols, and promote their adoption.
• Support project teams in defining the appropriate level of validation required based on a risk assessment.
• Support project teams in creating the agreed-upon set of validation documents to support the validated state.
• Support business functions in the periodic review of systems to assess the current validated state.
• Act as a quality contact and subject matter expert (SME) for computer system validation (CSV) and risk management.
• Review proposed changes to validated computerized systems and identify necessary validation requirements to maintain the system's validation status after the change is implemented.
• Support project teams in evaluating new proposed computerized systems or software to determine their impact on good manufacturing practices, and when such impact is identified, provide guidance on a risk-based system validation approach, collaborating with key stakeholders to achieve business objectives.
• Support formal testing of computerized systems, ensuring that test plans, test scripts, and test results are compliant with risk-based regulatory requirements.
• Ensure that the local validation master plan is maintained and aligned with the company's computer system validation policies.
• Participate in all types of audits and respond to audit observations and corrective actions regarding computer system validation.
• Interact professionally with senior management, internal services, and other business areas to effectively implement and maintain quality systems related to CSV.
• Identify and implement improvement opportunities with the Principal Process CSV Analyst for established quality systems, processes, procedures, and training to support IT CSV activities.
• Maintain up-to-date knowledge of evolving regulatory requirements, current/new techniques, and literature related to compliant computer operations, and act as an information source for the team and the broader organization.
• Perform any other activities as necessary from time to time.

Education and Experience

• Bachelor’s degree preferred.
• 2+ years of experience in the validation and qualification of complex computerized systems.
• In-depth knowledge of cGMP regulations related to CSV.
• Good written and verbal communication skills.
• Competent user of Microsoft Office.

Technical Skills

• Familiarity with several types of systems, such as ERP and BI, LIMS, HRIS, etc.
• Good understanding of business needs, high-level solutions, and infrastructure components, combined with experience in CSV systems.
• Extensive experience with various regulatory requirements related to Eudralex Annex 11, FDA CFR 21 Part 11, etc.
• Experience with the implications of the regulated environment on data integrity.

Team Skills

• Confident communicator, able to work effectively in a diverse business community.
• Proactive and professional approach, undertaking tasks and responding to business requests in a positive and constructive manner.
• Maintain up-to-date knowledge of the industry and organization to provide current solutions and be well-positioned to advise on future capabilities.