Biotech Quality Systems QA Specialist, Dun Laoghaire, Dublin
Office/Project Location:Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: On Site
Pay: €Neg per hour
Experience: 3+ 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.
Responsibility and oversight for the development and maintenance of site quality systems, quality compliance and related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, oversight of applicable QMS systems supporting and the overall Quality Management Review process.
Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Oversee and implement Quality Agreements relating to area of responsibility.
Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines associated to Amgen Quality Systems.
Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures.
Oversight and management of Quality Risk Management (QRM) Processes and for the embedding of QRM principles within the quality framework.
Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes and Documentation Management.
Responsible for trending programs associated with Deviation/CAPA, Change Control, Complaints, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.
Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance.
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. The knowledge and skills necessary to perform the duties of the QA Specialist are typically acquired through the following combination of education, experience and knowledge.
Ensuring that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at site.
Requirements
University degree. Engineering or Science related discipline preferred.
Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
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 / Deviation investigations.
Detailed Knowledge of applicable Regulatory requirements.
Experience with Regulatory inspections.
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Package
Contract role - Hourly rate €25 - €33 per hour
Minimum 12 month contract
Location: Fully onsite, with hours from 08:00 to 17:00.
On-Call: You'll be on rotation every 8 weeks. If a bioburner sample pops up, you'll need to step in and handle the testing.
OT/DT Eligibility: Yes
Shift Rate: 35%