CSV Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Philadelphia, USA
Posting date: 30 Jan 2020
QA.BP.27587

Proclinical is currently recruiting for a Computer Systems Validation (CSV) Specialist for a pharmaceutical company located in Philadelphia, PA. Successful candidate will be to ensure all computerized systems used to support GMP operations are appropriately validated and controlled. You must be able to interact with multiple departments throughout the company, be able to develop and provide training on Computerized System Policies, SOPs and industry regulations.

Job Responsibilities:

  • Ensure all computerized systems are appropriately validated
  • Prepare and review all levels of computerized validation documents (internal and external SDLC)
  • Perform audits as CSV Subject Matter Expert of suppliers and external service providers
  • Maintain all computerized systems and update them as required
  • Develop, update and maintain all procedures related to the computerized systems
  • Provide training as it relates to the development and implementation of processes and procedures
  • Ensure management of data throughout life cycle (e.g. Back Up, Restore, Disaster Recovery, and Retention)

Skills and Requirements:

  • A minimum of 2 years of Computer System Validation
  • Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, etc.)
  • Must have knowledge and experience of CSV and GAMP
  • Good understanding of Pharmaceutical Applications/software's (ERP, Trackwise, Chromatography (Empower 3) and non-chromatography software in Quality Control)
  • Understanding of Part 11 compliance and other regulatory requirements related to CSV
  • Ability to work on multiple projects independently or as part of a team

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Brandy Plumb at (+1) 646-367-2745 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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