Document Control Consultant

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Richmond, Virginia
Posting date: 30 Apr 2019
QA.KM.22990_1556623448

An international civil engineering firm is currently recruiting for a Document Control Specialist to join their office in Virginia and West Virginia. The company provides a full spectrum of services including scientific, technical, professional and construction- and program-management for business, industrial, commercial, government and infrastructure sectors. This this position shall be responsible for the development and execution of CQV documentation on a variety of equipment, facilities, utilities, components, products, and systems for a diverse client base of biotechnology, pharmaceutical, medical device, gene therapy and cell therapy manufacturers.

Job Responsibilities:

  • Provide CQV support to clients that manufacture GMP products on a consistent basis in conjunction with industry best practices.
  • Develop CQV planning documents to manage CQV projects.
  • Generate and execute CQV protocols using Good Documentation Practices (GDPs).
  • Investigate and resolve protocol exceptions or discrepancies.
  • Develop technical reports and CQV summary reports.
  • Start-up equipment in a safe and effective manner.
  • Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.).
  • Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation.
  • Perform risk assessments and impact assessments.
  • Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients.

Skills and Requirements:

  • A university/college degree in a relevant field.
  • Demonstrable related experience.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Keri Marshall at +44 207 440 0679 or upload your CV 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.

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