· Perform all activities in compliance with safety standards and SOPs
· Write, review and approve Standard Operating Procedures in accordance with Policies.
· Provide Quality support for triage and investigation of all classes of non-conformance (NC) events
· Review and approval of NCs and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
· Participates in customer complaint investigations.
· Provides training and advice to staff in order for them to perform their desired functions.
· Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program
· Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
· Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
· Support continuous improvement and Operational Excellence initiatives
· Any other tasks/projects assigned as per manager's request.
· University degree. Engineering or Science related discipline preferred.
· Relevant experience (4 yrs) working in the pharmaceutical or biotechnology industry
· Excellent written and verbal communication skills
· Experience working with dynamic cross-functional teams and proven abilities in decision making
· Strong organizational skills, including ability to follow assignments through to completion
· Experience working in aseptic operations, protein formulation, vial and syringe filling.
· Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists