IT QA Lead Consultant

Remote

Posted: 08/01/2022

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**This is a Consulting Role**

SQA Group is a tech and advisory services firm helping companies maximize two business differentiators — quality and data. We help both tech and business leaders see around corners, stand-up new capabilities, and elevate software quality and data as competitive advantages that help drive towards next.

Our client, a leading pharmaceutical company, is seeking a highly qualified IT QA Lead Consultant to support their GMP, GDP 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 Bring

  • Strong knowledge in Cell and Gene therapy development and manufacturing systems; PLC, Automation, LIMS, PAT
  • Performing Quality Assurance function related to Computerized Systems / Infrastructure
  • Proficiency with regulations related to FDA / MHRA regulations
  • Use of computerized quality management systems
  • Experience with validation of Enterprise / Lab Computerized Systems
  • Quality metrics, dashboards, analysis, and improvement programs
  • Knowledge of GAMP and Agile validation lifecycle and methodologies

 

What You’ll Do

  • Develops understanding of regulations pertaining to the implementation and use of computerized systems in GCP / GMP areas
  • Participates 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
  • Reviews and approves system lifecycle deliverables for new and modifications to existing computerized systems used in the GCP / GMP areas
  • Consults with CSQM team members and relevant internal stakeholders to identify / define high-risk areas with the intent of focusing on patient safety, product quality, and data integrity
  • Identifies and escalates areas of risk or non-compliance to manager / leadership team
  • Participates in performing Periodic Review activities of Computerized Systems
  • Provide support to regulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities

 

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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