IT QA, Periodic Review

Remote

Posted: 05/10/2022

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**This is a Consulting Role**

SQA Group is working with a leading pharmaceutical company that is engaging us for additional bandwidth in its IT QA team. We’re looking for an IT QA resource to support GLP and Google Cloud Platform and GVP systems.

This position will be responsible for supporting the Computerized Systems Quality and Management (CSQM) group working closely with the operational functions and other QA groups to provide oversight of GxP computerized system implementation, maintenance, and retirement. This role will review and approve computerized system lifecycle documentation as well as provide GAMP, Part 11/ Annex 11, and data integrity expertise to key stakeholders.

 

What You’ll Do:

  • Develop understanding of regulations pertaining to the implementation and use of computerized systems in Google Cloud Platform / GLP areas
  • Participate in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5
  • Review and approve system lifecycle deliverables for new and modifications to existing computerized systems used in the Google Cloud Platform / GLP areas
  • Consult with CSQM team members and relevant internal stakeholders to identify/define high-risk areas with the intent on focusing on patient safety, product quality, and data integrity
  • Identify and escalate areas of risk or non-compliance to manager/leadership team
  • Take over the execution of the periodic reviews and look at the bigger picture while they are doing that; Help evolve the program to make it more efficient, think continuous improvement
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities

 

Who You Are:

You have experience with Quality Assurance functions, related to Computerized Systems. Additionally you are:

  • Proficient with regulations related to FDA / MHRA regulations
  • Experienced using computerized quality management systems
  • Experienced with validation of Enterprise / Lab Computerized Systems
  • Experienced with quality metrics, dashboards, analysis and improvement programs
  • Knowledgeable of GAMP and Agile validation lifecycle and methodologies
  • Experienced with auditing- internal or external audits (FDA, EU, etc.)

 

Consultant Testimonial:

“From the start, everyone at SQA Group made me feel very welcome. The hiring and onboarding process was seamless, including regular one-on-ones that were informal in nature and allowed me to get more familiar with the job itself and with SQA Group as a company. What stands out for me about the company and its people is the level of personability and their willingness to help and make you feel comfortable. They make sure you have all the resources needed to be efficient and productive.”

 

Thank you for your interest in pursuing a career at SQA Group! This role is fully remote. SQA Group is an equal opportunity employer and supports workforce diversity. This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities above are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. All requirements are subject to possible modification to reasonably accommodate individuals with a disability

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