Csv Specialist

CSV Analyst (9 month contract)
Hatfield based with some remote working
With the purpose to be 'the gateway to patients worldwide', the organisation drives to become 'Smarter' with a more integrated, automated, and real data driven operation. They therefore have started their digital transformation journey towards Smart factory.
You will sit within the team who is the partner of the manufacturing site and a key driver of the transformation journey. The CSV Specialist will play an important role in the journey.
Main duties/responsibilities:

- Plan, write, implement, and review the computer systems validation (CSV) protocols in place
- Documentation - write, maintain, review, and update validation documentation, and approve validation SOPs.
- Review validation data, compile reports and support internal & external audits if required.
- To implement cGMP, MHRA and FDA requirements across IT systems and to ensure compliance to these and current best practices.
- Review potential suppliers for their suitability to supply computer software and equipment to GMP/GAMP standards.
- Assess the impact of any changes to manufacturing systems with the relevant SME / Vendor
- Provide CSV advice and recommendations to IT department and other stakeholders as required
- Training staff on the computerised systems in line with the relevant protocols and regulations.
- Stay informed with latest technological developments within the manufacturing industry.
- Propose and implement validation process and efficiency improvements.
Experience required:

- Understanding of Computer Systems Validation (CSV)
- Understanding of GAMP
- Solid experience of CSV in a pharmaceutical manufacturing
- Understanding of GMP and its implications on ICT
Skills and aptitude required:

- Self-starter, ability to work under own initiative
- Attention to detail
- Comply with Good Manufacturing Practise (GMP)
- Ability to identify, understand and convert business opportunities into technical solutions
- Excellent communication skills
- Ability to multitask, work flexibly and work well under pressure and to tight deadlines
- Excellent documentation, reporting and presentation skills in English
- Logical/structured approach to problem analysis
- Good team player
- Logical and strategic thinker with good problem solving and decision-making ability
Gi Group Pharmaceuticals provides a tailored Account Managed Service and dedicated Pharmaceutical recruitment team and partners with many different Pharmaceutical and Biotechnology clients throughout the globe and the United Kingdom.