QA Operations

  • Cork
  • Contract 23 months
  • JO-1904-64370_1557227659

Summary

RESPONSIBILITIES

  • Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
  • Review and Approval of electronic and paper production batch records
  • Daily presence and support on the manufacturing floor Release of Raw Materials for production
  • Support the Technology Transfer of a new product into the site including raw material and supplier qualification.
  • Support quality systems on site
  • Review and approve new or updates to standard operating procedures (SOPs) and master batch records
  • Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
  • Review and approve Change Control documents
  • Assist with regulatory inspections.
  • Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities,
  • Continuous Improvement/Lean initiatives
  • Compile and present metrics as assigned


Requirements

  • Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required
  • Minimum 3 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.
  • Experience and ability to work cross functionally
  • Experience in supporting manufacturing operations and batch record review is highly desirable
  • Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

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