Quality Assurance Specialist - Incoming Inspection, Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €30 - €40 per hour
Experience: 4+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
You will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components.
You will report to a QA Manager and will serve as Quality point of contact for Incoming Inspection of Primary and packaging components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr.
Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Testing of primary and secondary components for use in the manufacture of aseptic products.
Sampling of Excipients and Drug Substance under Grade C conditions.
Review/approve documentation associated with component testing in preparation for QA Specialist or Qualified Person disposition activities
Compiling, Review and approval of minor deviation's 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 with suppliers of components.
Provide training and advice to staff in relation to testing of components and packaging.
Actively participate in audits and their preparation.
Review and approve cGMP records (e.g., WO, JP, GDMS, Deviation, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
Perform all activities in compliance with safety standards and SOPs
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager's request.
Requirements
Must Pass Eye-Tests required for Visual Inspection
University degree. Engineering or Science related discipline preferred
Relevant experience (4 yrs. +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
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
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Package
Contract role - Hourly rate €30 - €40 per hour
Minimum 12 month contract
Onsite Expectations: Onsite Role
Shift Patterns:
• 07:00 to 15:00, Monday to Thursday, 07:00 to 14:00 on a Friday
• Late shift is from 14:30 to 22.30 Monday to Thursday, 13:30 to 20:00 on a Friday.
Shift Rate: 20%