Careers

Computer Systems Validation Specialist/Lead – RPA

Are you a Computer Systems Validation Specialist or Lead with 7-10 years experience implementing QMS for automation in GMP environments, with some focus on RPA?

SQA’s client, a leading global life sciences company, is seeking a CSV Specialist/Lead with 7 plus years experience for a 3-month contract (through December 2019) in St. Louis, MO.

Duties:

  • Develop RPA (Robotic Process Automation) implementation strategy for regulated and non-regulated processes
  • Perform quick “As Is” study of current processes followed by the RPA teams
  • Gap analysis to meet QMS requirements benchmarking to ISO 9001, GMP Validation requirements, based on As Is and industry best practices.
  • Develop list of policies, procedures, and guidance needed for controlled BOTs development, deployment, retirement, lifecycle management, GMP validation/qualification (RPA-QMS for LS) including security requirements.
  • Develop the policies, procedures, and guidance documents/templates to meet the benchmark requirements and QMS requirements. For both GMP and Non GMP areas, leveraging existing information as applicable. (Goal: Simple and basic)
  • Collaborate with Corporate Quality to ensure corporate standard requirements are aligned
  • Coordinate the reviews and approvals of RPA-QMS documents
  • Identify qualification requirements that need to be completed for the existing RPA development / testing IT Infrastructure
  • Create list of recommendations for the existing running BOTs / in development BOTs to meet the RPA-QMS.
  • Preparing overview training material for RPA-QMS and release
  • Final summary report of the project deliverables and its status and handover.

You will need the following:

  • Experience creating Validation/Qualification strategies and frameworks for RPA implementations
  • 7 plus years of experience implementing QMS for software development in cGMP environments
  • Deep working knowledge of GAMP, 21 CFR part 11, and ISO 9001 QMS, and creating SOPs and templates to these standards
  • Ability to socialize, collaborate, and agree upon strategies with different key stakeholders (i.e. Corporate Quality)
  • Ability to work effectively with globally distributed teams; strong communication skills
  • Basic exposure to RPA development software (Blue Prism or UiPath or Automation Anywhere)

Job ID:1909-5792

SQA is an equal opportunity employer and supports workforce diversity.