Description
Our client is a leading life sciences company with operations across the globe and as a result of growth and an increase in staff numbers they are looking to attract a Validation Engineer for Computer Systems on a contract basis for an initial 12 month period based at their facility in the West London area.
Candidates must have a GMP background in Validation within pharmaceutical or Biotechnology projects. Candidates must have experience of generating and executing protocols (IQ/OQ/PQ) and will ideally have experience of HVAC systems, utilities and equipment validation associated with fermentation processes.
You will be required to assess the validation requirements of the IT Infrastructure ensuring all Regulatory, FDA and MHRA requirements are met.
Skills and Experience:
- A strong working knowledge of the QA review and testing process, designing test scenarios and test scripts, including understanding a various testing techniques
- Up-to-date knowledge of regulations, with excellent knowledge of FDA and MHRA with training and experience in GMP
- Candidates will be familiar with the verification of machinery and equipment usually consisting of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ)
- Good Automated Manufacturing Practice (GAMP 4 or 5)
Role and Responsibilities:
- The purpose of the position is to provide Quality review of validation documentation, to ensure compliance with cGMP, GAMP 5, Corporate Directives, FDA and EMA Regulations and ICH and PIC Guidelines
- Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols
- Participate in GMP Risk Assessments and FMEA`s, compliance review of Risk Assessment documentation, maintaining an up-to-date knowledge of EMA and FDA regulatory requirements
- Validation Lifecycle, Validation Summary Reports and Validation Protocols
Location:
London
Applications:
To hear more about this fantastic opportunity for an initial 12 month contract working as an Validation Engineer (GAMP, FDA, MHRA) for the Pharmaceutical sector; please call Ruth Maskrey here at IS Recruitment in our Manchester office or email me a copy of your very latest CV for an immediate call back.