Job Details

  • Title: QA Validation Specialist
  • Code: RCI-BI-9192704
  • Location: Gainesville Georgia (GA) 30501
  • Posted Date: 05/16/2019
  • Duration: 6 Months
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  Job Description

Ensure that requirements for initial or on-going qualification/ validation for premises, equipment and information systems (PEIS) are documented to allow life-cycle traceability in accordance with cGMP practice. As a member of Quality Assurance function the specialist ensures Validation Master Plans are developed, updated, audited and executed. 

The Specialist will function as part of the Industrial Operations manufacturing and/ or project core teams. As a representative of the Quality Assurance department, the Specialist shall perform the required activities below:

  • Perform criticality analysis for initial or on-going validation/qualification based on the Global Quality standards and regulatory requirements
  • Develop and document the process and project Validation Master Plans (VMPs)
  • Plan and structure validation activities for facilities and equipment in coordination with engineering project management and/ or manufacturing management
  • Attend and monitor execution of factory acceptance testing at supplier’s site when necessary
  • Ensure that the validation activities identified in the VMP are implemented and documented through protocols for design, installation, operational, software and performance qualifications
  • Develop a project validation summary report at the end of the project based on validation reporting template requirements
  • Hands-on Process Validation Master Plan support, develop validation protocols, review and audit protocols, update the VMP’s, in collaboration with manufacturing teams
  • Perform and assist with the execution of validation activities
  • Responsible for hands-on training and development of manufacturing capability in execution of validation
  • As Lead role, maintain and report environmental monitoring results to QA and site senior management and also to facility owners.  Develop and report metrics as needed.
  • As Lead role, ensure all manufacturing sites water systems are compliant with Global Quality standards.
  • Adhere to all HSE guidelines and regulations
  • In addition to the above, other assigned duties & projects deemed appropriate within the position scope

Required:
experience in the pharmaceutical and/or biological validation field
  • Requires knowledge of the current GMPs and USDA requirements
  • Requires frequent walking, stooping, bending, twisting, turning, and standing for extended periods of time and some lifting, pulling or pushing up to 50 lbs.
  • Must be able to stand for extended periods of time and work in a sterile production environment
  • Must be able to wear appropriate Personal Protective Equipment (PPE)
  • Proficient with Microsoft Office software and other database software
  • Requires frequent walking, stooping, bending and standing for extended periods of time and some lifting.