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Job Details

CSV Specialist, Medical Devices, Worthing, £DOE

Company: Meet
Location: Worthing, Brighton, Crawley, Chichester
Reference: NB-CSV-SE
Closing Date: 16 Dec 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Are you someone with an understanding of manufacturing processes and how ERP systems are used by a business? This particular company are looking to bring in a self-starting CSV Specialist with a high standard of technical report writing to assist the company in their growth.

Requirements:

CSV Specialist, £DOE, Worthing, Medical Devices

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Objectives:

  • To help with the implementation of Computerised System across the company
  • To drive efficiency improvements within CSV tasks and other areas as required
  • To work in partnership with departments across the company, in particular IT

Responsibilities:

  • Determining validation requirements for computerised systems and manufacturing systems in accordance with a risk based approach
  • Develop validation knowledge and skills throughout the company to ensure all personnel can fulfil their defined roles & responsibilities effectively
  • Lead validation planning with cross functional teams to ensure that an appropriate risk-based approach is taken and then executed in accordance with the company’s procedures to meet project deadlines
  • Manage all validation activities, which include the development, writing, execution, review and approval of the suite of documents including but limited to: validation plans, validation protocols and report
  • Evaluate, investigate and document non-conformances incidents and/or protocol deviations
  • Complete assigned non-conformance and CAPA investigations and prepare investigation reports
  • Participate in the development of the new processes, process transfers and continuous improvement and issue resolution

Skill Required:

  • A minimum of five years in a CSV role or equivalent
  • Working knowledge of ERP systems and other business system
  • Working knowledge of GAMP5
  • Working knowledge of 21 CFR Part 11 & Orange Guide Annex 11
  • Experience of working in a Medical Device, Pharmaceutical or similar regulated industry

Please contact Nathan Berkley on 0203 019 6020 or email nathan@peoplewithchemistry.com if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We’re proud to partner with the industry’s leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available.  We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at: www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/

Key Words

Medical Devices, IVD, Validation, CSV, CSV Specialist, CSV Engineer, ERP, 21 CFR, CAPA, GAMP5, Computer System, Worthing, Crawley, Brighton, Portsmouth, Chichester, South East

Apply for this job: CSV Specialist, Medical Devices, Worthing, £DOE

Contact Information:

Address:  meet
Irongate House, 30 Dukes Place, London
EC3A 7HX
England
Tel:  +44 203 178 7488
Website:  Visit Our Web Site

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