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Job Details
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CSV Technician - south east Scotland

Business Type: Pharmaceutical Company, Internet - IT Services, Pharmaceutical Services
Job Type: Validation, Information Science, Human Resources, Information Technology
Job Level: Experienced (non manager)
Position: Full Time
Salary: excellent employee package
Location: United Kingdom
Reference: PHA/226265/HM/001
Closing Date: 27/09/19
Job Details:

Reporting to the CSV Analyst and working within the IT and Quality Functions, across all sites the CSV (Computer Systems Validation) Technician is responsible for:

  • Assisting the validation of computerised systems in a GxP environment and the preparation of CSV documentation including Risk Assessments, Validation Plans, User Requirements Specifications, Qualification Test Protocols, Test Scripts, and Validation Reports.
  • Monitor CSV activities within own area of accountability, to ensure quality and compliance with all legislation, regulations and standards.
  • Manage relationships effectively with a wide range of internal and external individuals and bodies during any CSV assignment.
  • Ensure information produced by CSV activities is available to and applied correctly in any relevant, related activities such as business change management.
  • Identify and implement the procedures, tools and techniques applicable to CSV activities to maintain/track/improve computer system compliance within the company.
  • Provide CSV expertise and risk analysis in order to agree the validation approach, if any, for projects and change control requests.

This Job Contributes To Organisational Success

  • Work with internal and external sponsors and stakeholders for a CSV assignment.
  • Apply best practice in CSV and lessons learned from prior experience in CSV assignments.
  • Use the procedures, tools and techniques for undertaking CSV as directed by the CSV Analyst to monitor the alignment of CSV activities with all relevant legislation, regulations and standards.
  • Identify opportunities to improve the quality and effectiveness of CSV activities.
  • Identify and select the actions to be taken in the event of the deliverables of CSV being incorrect, incomplete or inadequate.
  • Monitor and report on compliance with all relevant legislation, regulations and standards relating to CSV and the effectiveness and quality of CSV activities.
  • Manage the alignment of CSV activities with all relevant legislation, regulations and standards.
  • Conduct CSV assignments that may contain complex, non-routine and strategic issues that need to be addressed.
  • Communicate effectively and in a timely manner with sponsors, stakeholders and external bodies on all aspects of CSV activities.

Job Requirements

  • An undergraduate degree or recognised technical diploma in a Computer Science or Life Science related field, or relevant professional experience.
  • Excellent understanding of system compliance regulatory requirements and guidelines.
  • At least 2 year''s experience of Computer System Validation with regulated industries to recognised standards.
  • Working knowledge of systems such as Laboratory Systems, Document Management Systems Proficiency in both verbal and written communications and possess a high degree of personal integrity and interpersonal skills.
  • Leadership and teamwork skills.
  • Strong problem solving, analytical, technical acumen and organisational skills.

The role will require travel between two south east offices in Scotland.

Company Benefits

We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In addition to a competitive salary, we offer as a minimum: Pension scheme, Share Incentive Scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.

To apply please send a Word doc with no graphics or pictures or contact Heather Murray via our UK number found on our website by searching NonStop Pharma and quoting my extension 5112.

If you do not hear from me you might not have the exact skills required for the position, however, I will make sure to keep your profile for any other possible opportunities.

The job market changes very quickly so do not forget to connect with me on LinkedIn, check other roles that I am hiring for at the moment and follow for any future relevant roles.

Posted: 20/09/2019 | NPJ Ref: 242190
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