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- First degree or equivalent in a scientific/engineering discipline.
Knowledge & Experience
- Minimum 5 Years Current Experience in Bio-Pharma Industry
- Minimum 3 Years Experience in a Validation Role (2 Years of which should be in Computer System Validation)
- Detailed knowledge and practical experience of Software Development Life Cycle (SDLC) approach to Computer Systems
- Detailed Knowledge and practical experience of GAMP 5, in particular categorisation and Assessment of Computer Systems.
- Demonstrated understanding and application of industry standard validation practices and documentatation, i.e. IQ, OQ, PQ, Hardware Design Specifications, Software Design Specifications etc
- A thorough understanding of Good Manufacturing Practice (cGMP) is essential.
Key Elements of Role
- Preparation and Execution of Regulatory/Validation/Risk Assessments for Computer Systems in accordance with Company Procedures
- Execution of required validation activities where identified by risk assessment
- Preparation of documentation for Computer System Validation activities complying with company procedures and industry standard practices.
- Preparation of project plans identifying key milestones and resolving resource bottlenecks in order to achieve stated deadlines. Generation of regular status reports
- Preparation of detailed validation reports, summarising validation exercise, identifying potential problem items and recommendations for resolving such issues.
- Highly Literate and Numerate
- High level of competence with computer software packages i.e. MS Office Suite, particularly MS Word/Excel
- Demonstrable Technical Aptitude in the area of Computer System Validation in the Pharmaceutical Industry
- Good data analysis/presentation skills. Generation of high quality documentation to a standard that will be suitable for scrutiny by internal and external regulatory bodies..
- Excellent planning/organisational competence and strong commitment to deadlines
- Extensive verbal and written communication skills in order to be able to communicate clearly at all levels.
To apply for this role please send CV or call Rachel Smith on 0207 758 7322.
To find out more about Real please visit www.realstaffing.com