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QA Oversight / Systems Compliance Specialist

Bothell, WA · Biotech/Pharmaceutical
Title: QA Oversight / System Compliance Specialist
Type of role: Consultant - 100% Remote


Our direct client is looking for an QA Oversight / Systems Compliance Specialist This person should have the ability to work closely and collaborate with various business partners including IT, GMP QA and Business customers and vendors. In addition, this role will support QA review/oversight for GxP computer systems used in support of GCP, GLP, GPvP and limited GMP activities. This position will provide the assigned level of systems compliance support and validation oversight for validation and maintenance of electronic systems.

Core Responsibilities: 
  • Supports internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with our customer’s standards and regulatory requirements such as 21 CFR Part 11, Annex 11, ICH E6 R2, OECD Advisory Document 17, applicable Predicate Rules, etc.
  • Provide compliance support for the validation and maintenance of electronic systems in accordance with computer system validation (CSV) procedures and regulatory requirements
  • Review and approve CSV deliverables such as Validation Plans, Requirements, Test Scripts, Trace Matrices, Validation Summary Report, etc. associated with the validation and maintenance of computerized systems
  • Support updates to management on projects, health of the CSV process and communicate risk-based escalation issues, when applicable
  • Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects
  • Support the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. Works closely with IT and software/system vendor(s) as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable
  • Supports the interpretation of CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements
  • Liaises with IT and other cross-functional business teams to ensure that electronic systems for issue management and general IT compliance support
Role Requirements:
  • Bachelor’s degree in technical, scientific or other relevant academic discipline and a minimum of 5 years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 3 years of experience in audits and oversight of GxP Computer System validation or equivalent experience and/or education
  • Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or regulatory authority regulations and guidance’s related to CSV (such as, GCP, GPvP, GLP, GMP, GAMP, Part 11, Annex 11, ICH E6, OECD, etc.) activities and compliance
  • Excellent verbal and written communication and skills
  • Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
  • Knowledge of word-processing, spreadsheet, and database applications
  • Extensive knowledge of pharmaceutical research and development processes and regulatory environments
  • Considerable knowledge of quality assurance processes and procedures
  • Strong interpersonal skills
  • Experience with Research and Development systems such as Argus, CTMS, Veeva, SoftMax Pro, RIM, ALM and other GCP, GPvP and GLP systems implementation, applications audits that are Internal or Vendor

 

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