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Contact Info
Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

Snr Associate QA


Reference:JSC00032151 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

24/7, 12hr shift role - Eye Test Required for this position - Inspection Role.

Primarily dealing with manufacturing activities, troubleshooting issues in production. Quality contact on deviations. Batch record review for manufacturing.
SOPs. filling, setups and work on lines, inspection, triage issues relating to manufacturing activities, reviewing complaints.
Floor walks
Good communicator.
Escalate issues to Managers.
Flexible.
Problem solving and trouble shooting. Sterile manufacturing background (even micro) Aseptic manufacturing background is a must.
Critical thinking around aseptic practices.
Min industry experience 2 years + (Ideal candidate would have at least 3 years’ experience, QA background who has worked in a sterile manufacturing area)
Candidates need to be happy to work on shift.
Candidate's need to have good examples of troubleshooting and ability to work alone.
Team is made up of 4 shifts, each made up of 1 manager with 5 reports (12 hours shifts.) Hopeful FTE role on Shifts (a shift allowance applies) will start approx 3 weeks from start date upon completion of training

The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, PQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
This is a 24/7 shift role required to support manufacturing operations.

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, vial and syringe inspection.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Perform all activities in compliance with safety standards and standard operating procedures.
o Observe and provide real-time quality oversight and support for manufacturing on the floor.
o Perform purposeful presence on the floor audits.
o Perform manual visual inspection AQL audits of vials and syringes.
o Perform QA reserve sample inspections as part of the annual reserve inspection program and in support of customer complaint investigations
o Certification of defect panels.
o Provide quality support for triage and investigation of all classes of deviation events.
o Review/approve deviations for closure ensuring compliance with appropriate standards.
o Review/approve production batch records, and associated documentation in preparation for qualified person disposition activities.
o Provides training and advice to staff in order for them to perform their desired functions.
o Write, review and approve standard operating procedures in accordance with policies.
o Support continuous improvement and operational excellence initiatives
o Any other tasks/projects assigned as per manager’s request.

Education & Experience

o University degree. Engineering or Science related discipline preferred.
o 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.
o Excellent written and verbal communication skills.
o Experience working with dynamic cross-functional teams and proven abilities in decision making.
o Strong organizational skills, including ability to follow assignments through to completion.
o Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.
o Experience working in aseptic operations, protein formulation, vial and syringe filling.
o Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.