Csv Validation Specialist

**About Torbay Pharmaceuticals**

At TP we have our own special kind of chemistry. Our heritage spans over 50 years with a track record of manufacturing essential medicines across the UK and beyond. With backing from an investment partner are now forging a new path in the private sector.

We are a growing and ambitious business and with this comes opportunities for our people. At TP, we are going places. A career with us means a career helping save lives. We bring skills of all levels and experiences together; not all of our people begin their working lives in pharma.

Together we can make lives better.

**Position**:
Do you have excellent attention to detail and advanced analytical skills? Are you an experienced CSV Specialist? Are you a contractor looking for your next role? If yes then this role could be for you.

Torbay Pharma are currently looking for a CSV Validation Specialist to join our team based in Paignton on 4 month contract. Torbay Pharma are currently going through a significant IT infrastructure transition, migrating servers and equipment from the current domain/data centre to Azure, this role is pivotal in ensuring seamless compliance with FDA and MHRA regulations. The CSV Validation Specialist will work closely with the IT department and lead the development and implementation of validation protocols, ensuring the accuracy, integrity, and regulatory compliance of data transferred to the new IT environment.

**About the Role**

Reporting into the Head of IT this role will actively contribute to ongoing IT system enhancements, driving continuous improvement and operational efficiency. Success in this role hinges on meticulous attention to detail, advanced analytical skills, and a deep understanding of CSV principles and IT frameworks.

**What you can expect in a CSV Validation Specialist role at TP**:

- Lead the creation and development of validation protocols tailored to the specific requirements of IT infrastructure transitions.
- Ensure that validation protocols adhere to regulatory standards, including FDA and MHRA guidelines, FDA 21 CFR Part 11, EU GMP Annex 11 and align with company policies and procedures.
- Develop and execute validation protocols and test scripts for IT systems and equipment to ensure compliance with regulatory requirements, industry standards, and company policies.
- Perform Electronic risk assessments and impact analyses for changes to IT systems and processes.
- Support IT Separation initiatives by validating servers, equipment, and systems to ensure seamless transition and continuity of operations.
- Provide technical expertise and guidance on CSV best practices and methodologies.
- Execute CSV activities in alignment with established protocols and procedures, ensuring that all validation tests are conducted accurately and efficiently.

**Requirements**:
**What are we looking for**:

- Previous experience in CSV, validation, or quality assurance role within the pharmaceutical industry.
- Proficiency in CSV principles, regulations (e.g., FDA 21 CFR Part 11, EU GMP Annex 11), and guidelines (e.g., GAMP 5).
- Experience with validation tools and methodologies, such as risk-based validation CSA, IQ/OQ/PQ protocols, and validation testing.
- Excellent communication skills, with the ability to effectively collaborate with cross-functional teams and communicate technical concepts to non-technical stakeholders.
- Detail-oriented mindset with a focus on accuracy, completeness, and data integrity.

**What we offer in return**

At the heart of Torbay, we offer roles and career opportunities on your doorstep that you won’t find elsewhere. With defined career pathways, and the chance to move between roles and different departments, we support your career journey at every stage. TP is going places. International expansion means growth and new opportunities.

Our benefits set us apart. With 27 days holiday as standard - and the chance to buy more, group life assurance, pension and more - we reward our people for getting the job done.