Shift Biotech QA Analyst

at  JobContax

Location: Ireland
Pay: EUR 30 - 40 Per Hour
Job Type: Contract
City: Dublin
Job ID: JO-2501-37361
Consultant: Karen McHugh
Shift Biotech QA Analyst - Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Site Based
Pay: €30 - €40 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 Laoghaire, 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.
You will report to a Senior QA Manager and is a core member of the site QA team.
The QA Snr Associate will act as Quality point of contact for manufacturing operations and is responsible for oversight of:
Medical Device assembly
Serialized Packaging and labelling
Perform all activities in compliance with safety standards and standard operating procedures.
Observe and provide real-time quality oversight and support for manufacturing on the floor.
Perform purposeful presence on the floor audits.
Perform manual pack check and deft assessment
Perform Batch Review to support customer complaint investigations
Provide quality support for triage and investigation of all classes of deviation events.
Review/approve deviations for closure ensuring compliance with appropriate standards.
Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
Provides training and advice to staff in order for them to perform their desired functions.
Write, review and approve standard operating procedures in accordance with company policies.
Support continuous improvement and operational excellence initiatives
Any other tasks/projects assigned as per manager’s request.
Purposeful Presence on the floor:
Triage

REQUIREMENTS

Minimum Qualification : Science Degree /Engineering degree
We would like to see someone with a QPA background
Batch reviews
Deviations
Open to considering candidates from a lab if they have deviation experience and demonstrate their ability to problem solve.
Strong attention to detail in terms of task execution and QA review.
Proven in Risk Based Decision Making – ability to assess both the impact of an event that occurs and the suggested path-forward.
Excellent written and verbal communication skills – ability to communicate across different teams/backgrounds & up/down different levels with the organisation.
Strong organizational skills, including ability to follow assignments through to completion – ability to work well on own and as part of a dynamic team.
Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
Operational Excellence / Continuous improvement experience – ability to identify areas for improvement & implement said improvements.
Problem solver
Advising and finding a complaint path forward
Previous Production experience
Ability to do shift role 24/5 (at the moment shift schedule can change according to business needs, notice will of course be provided of ant change to cycle)
We would like to see someone with a QPA background
Batch reviews
Deviations
Open to considering candidates from a lab if they have deviation experience and demonstrate their ability to problem solve.

Please refer the Job description for details