£55k per year
26 days ago
Title: CSV Specialist
Location: Houghton Regis
Rate: Up to £55,000
My client, a successful medical device manufacturer and distributer based in Luton, are looking to bring onboard a CSV Specialist, who will be a key player in the set IT and QSR set up across the company. The ideal candidate must have previous experience working within a similar type role and be familiar with the Software Development Lifecycle.
- Coordinate across IT function to validate systems as per CSV framework
- Create and Review Computer System Validation Documents and SDLC Documentation
- Contribute to Change Control Process, Impact Analysis and Risk Assessments
- Train Stakeholders in Computer Systems Validation Framework including preparation of training material
- Train Stakeholders in Software Development Life Cycle including preparation of training material
- Perform internal audits of CSV packages.
- Participate in internal and external Q&E MS audits and external vendor audits.
- Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP), MAP, etc.
- Bachelor’s Degree in Computer Science or IT Engineering or equivalent
- The role requires international travel, approximately around 10%
- Past experience creating and reviewing documentation for Quality Systems or appropriate qualification in Business Systems Analysis preferred
- Experience in developing and working with Quality IT systems and CAPA Systems.
- Working Knowledge of GAMP’s
- Knowledge of applicable regulations and standards, e.g. ISO 9001, ISO 13485, FDAs QSR
- Eligibility to work in the UK
Looking but this isn’t the right position for you?
If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to firstname.lastname@example.org or call 0203 589 9294 for a confidential discussion about potential opportunities.
NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?
Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.
Catalyst Life Sciences:
Catalyst Life Sciences are a global recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;
- Pharmacovigilance/Drug Safety
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Medical Information
- Medical Writers
- Medical Affairs
- Clinical Trials
- Clinical Research
- Project Management
My LinkedIn Profile:
I personally specialise in recruiting QA and RA professionals for roles globally so please do get in touch should you be considering new roles, or looking to fill ones at your current company!