QA Specialist - Technical Support, Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid, one day a week on site
Pay: €50 - €58 per hour
Experience: 7+ 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 Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
The Quality Assurance Technical Support (QA TS) Specialist is a position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
Quality review and approval of Validation documentation and SOPs to support site validation activities:
Review of DS & QRAES documents
Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
Review of executed validation documents and reports
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Perform all activities in compliance with safety standards and SOPs
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
Requirements
University degree. Science or Engineering related discipline preferred.
Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Inspection, Validation, Quality Control, Engineering, Information Systems)
Understanding of principles of Validation and New Product Introduction
Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Ability to operate across functional boundaries, both internal and external.
Ability to work independently and remotely with minimum direct supervision.
Critical thinking skills.
Strong organisational, communication, coordination, and meeting facilitation skills.
Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
Package
Contract role - Hourly rate €50 - €58 per hour
Minimum 12 month contract
Work location: This is a hybrid role, so the preference here is for local candidates or candidates within a commutable distance to the site.
The expectation is for the successful candidate to be onsite at least once a week.