Job description
Conexus are seeking a detail-oriented CSV Compliance Specialist to create and deliver validation and qualification activities for projects to implement security and compliance solutions, ensuring adherence to the CSV framework. This role is not to guide or direct others but to deliver the documentation and testing as part of the CSV activities in projects.
You will be working for a leading, innovation-driven global pharmaceutical company specialising in the development and manufacture of peptides and oligonucleotides.
Key Responsibilities:
- Create and deliver CSV documentation, including Validation Plans, Requirements Specifications, Test Protocols, and Summary Reports.
- Ensure our security and compliance solutions and projects comply with QA and CSV procedures and regulatory standards.
- Work with project teams to collect information and guarantee precise documentation.
- Review and update CSV documents to reflect system and process changes.
- Execute validation tests as necessary.
- Train and support project teams on CSV documentation requirements.
- Stay updated with CSV best practices and regulatory requirements.
- Enable projects to comply with CSV requirements when run using Agile project management methodology.
- Coach other colleagues on validation and qualification activities, supporting training of teams news to CSV compliance in projects.
Skills & Experience Required:
- Bachelor's degree in computer science, IT, or related field.
- 3+ years of experience in delivering CSV compliance testing and documentation.
- In depth-knowledge of Waterfall and Agile project management methodologies.
- Strong experience in running CSV compliance activities for projects run in Agile.
- In-depth knowledge GMP regulations and guidelines applied in pharmaceuticals.
- Exceptional documentation skills, focusing on detail and accuracy.
- Independent worker capable of managing concurrent tasks.
- Effective communicator and team collaborator.
This is a fully remote working position, paying between £100 - £110 per hour (GBP). The contract is set to last for 12 months with the possibility of an extension.
Please select apply to send us an up to date copy of your resume. Alternatively, you can email , or call us now on +44 7488 887 233.
