Description
A CSV Specialist is required for a leading Pharmaceutical manufacturing site based within the North West area. This role will include working as a team to design and perform the validation activities associated with new installation projects and existing manufacturing process.The successful CSV Specialist will be responsible for the correct execution of CSV activities on site as well as ensuring compliance to EU GMP Annex 11, 21 CFR Part 11 & GAMP5
The key responsibilities and requirements for this role include:
- Have experience in the specific area of CSV
- Working as the CSV lead and executing the validation activities on site to ensure compliance with current regulations
- Run CSV projects execution ensuring that work is completed and the relevant timelines are met.
- Liaise with project team members
- Resolve both GMP and business issues and deviations
- Working with local, corporate and regulatory computerised system requirements to translate into validation requirements.
The ideal CSV Specialist will need to have had 2- 3 years working knowledge of writing protocol reports for Computer Systems within a pharmaceutical environment. This role will also require the ideal candidate to have effective communication skills, with the ability to priorities workload and be able to work under pressure to meet deadlines.
To learn more about this excellent opportunity to join a renowned Pharmaceutical company please send in your current CV to Reshma Patel or alternatively contact myself on