Compliance and Validation Specialist

Are you a Computer Systems Validation expert with knowledge of ERP systems?

SQA is working with a growing pharmaceutical company to support their Computer Systems Validation efforts. They have an immediate need for a Quality and Compliance specialist to oversee quality, compliance and governance of multiple Computer System Validation (CSV) projects, working against SOP’s, SLC and FDA regulatory guidelines.  Working directly with multiple business units, this resource will review and approve all validation documentation and oversee the execution of validation protocols for all GxP-impacted systems. The CSV specialist will provide guidance to project teams during the planning and definition phases to develop a validation approach commensurate to the risk level assigned to the systems. Subsequently, they will coordinate investigations into failures to meet acceptance criteria and determine appropriate corrective actions.

To be considered for this role, you should have:

  • Experience supporting Computer System Validation projects from start to finish, including the ability to oversee and evaluate all lifecycle phases and corresponding documentation
  • ERP systems knowledge (Oracle SCM preferred)
  • Knowledge of GxP, FDA and EU regulations, ICH guidelines, and applicable compliance standards
  • Ability to work well and collaborate with a wide range of team members: IT, vendors, business process experts, regulatory, and multiple stakeholders, especially under stress and with changing priorities
  • Experience managing external vendors (Cloud, hosted systems, SaaS, IaaS) through evaluation, audit, validation execution, implementation, deployment and ongoing maintenance/change control/support
  • Process Engineering and SOP development desired, but not required

Job ID: 1702-5355/1708-5459
Software Quality Associates is an equal opportunity employer and supports workforce diversity.