Computer Systems Validation (Csv) Compliance Engineer East Anglia, UK J0124RL
IT and Trading, East Anglia
| Job ref: | J0124RL |
|---|---|
| Position type | Permanent |
| Location | East Anglia |
| Industry | IT and Trading |
Vacancy details
Computer Systems Validation (CSV) Compliance Engineer – Permanent – East Anglia
A major Biotechnology / Pharmaceutical organisation has a fantastic opportunity for
a
Computer Systems Validation (CSV) Compliance Engineer to work within the IT team to
support the development and maintenance of Computer Systems/Software Validation
Procedures to ensure that current regulatory compliance and company objectives are
maintained.
The Role
- Act as change owner for all IT systems
- Tracking changes through to completion
- Supporting assessment processes
- Preparing and executing protocols and effectiveness reviews
- Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance.
- Provide IT support and assessment for relevant quality deviations
- Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of IT systems.
- Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review
- Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
- Design reviews and risk assessments
- Generating protocols/test cases
- Validation report
- Represent IT at internal audits.
- Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
- Work with Consultants/Contractors as required ensuring Validation documentation is completed as per approved procedures.
- Work with QA Validation department to ensure alignment between IT compliance processes and site CSV standards.
Experience
- Experience in the Pharmaceutical Industry or similar heavily regulated manufacturing environment.
- Working knowledge of cGMP, Annex 11, 21 CFR pt 11 and GAMP 5.
- Experience of design, installation and support of IT systems
An outstanding salary and benefits package is on offer alongside an exceptional opportunity to join a major Biotechnology / pharmaceutical organisation.
Please apply today with covering letter highlighting your key skills and relevant experience
aligned to this contract opportunity
Apply for this job:
- +44 1442 870 700
- E-mail recruiter
Related Jobs
- There are 62 other jobs in this industry - to see them, browse all IT and Trading jobs
- There are 7 other jobs in this location – to see them, browse all jobs in East Anglia