Description
Qualifications- 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.
Key Skills
- 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 .
To find out more about Real please visit www.realstaffing.com