CSV Specialist - Copenhagen, Danmark - Proclinical

Beskrivelse

The CSV Specialist will be responsible for designing, implementing, and executing CSV strategies and activities in compliance with regulatory requirements and industry standards.

This role offers an exciting opportunity to work with leading pharmaceutical companies and contribute to the success of their projects.

• Develop and implement CSV strategies, plans, and protocols for pharmaceutical computerized systems.
• Conduct risk assessments and gap analyses to identify areas for improvement in CSV processes.
• Perform validation activities, including IQ, OQ, PQ, and performance qualification (PQ) of computerized systems.
• Provide expertise and guidance on CSV regulations and guidelines, such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Collaborate with crossfunctional teams to ensure alignment of CSV activities with project timelines and objectives.
• Prepare and review validation documentation, including validation plans, protocols, reports, and standard operating procedures (SOPs).
• Support audits and inspections by regulatory authorities and clients, ensuring compliance with applicable regulations and standards.
• Stay informed about emerging trends and best practices in CSV and contribute to continuous improvement initiatives within the organization.

• Bachelor's or Master's degree in engineering, computer science, or a related field.
• Minimum of 5 years of experience in CSV within the pharmaceutical or biotechnology industry.
• Indepth knowledge of CSV regulations, guidelines, and standards, including GAMP 5, FDA 21 CFR Part 11, and EU Annex 11.
• Experience in designing and executing CSV activities for a variety of computerized systems, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), and electronic document management systems (EDMS).
• Strong analytical and problemsolving skills, with the ability to assess complex systems and identify compliance risks.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal teams and external stakeholders.
• Proven ability to manage multiple projects simultaneously and deliver results within established timelines.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.