Quality Specialist, Gxp Audit, and Inspection (v770)

  • Contract Duration: 6++ months
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Excellent REMOTE GxP Quality opportunity !!!

Lenox Executive Search is seeking a Quality Specialist I to fill a 6++ month contractual role with potential to extend, with a leading global pharmaceutical company located in Boston, MA. 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 internal stakeholders.

RESPONSIBILITIES of the Quality Specialist, Audit, and Inspection Management:

  • 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 on 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 toregulatory inspection preparedness activities as needed
  • Experience performing Infrastructure Qualification activities

 

MINIMUM QUALIFICATIONS of the Quality Specialist, Audit, and Inspection Management:

  • Bachelor’s degree and relevant GxP work experience
  • Proficiency in using Microsoft Office application

PREFERRED QUALIFICATIONS:

  • 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.
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