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Contact Info
Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

QA Senior Associate


Reference:JSC00030435 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

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.

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.

Duties

• Primarily dealing with manufacturing activities, trouble shooting issues in production.
• Quality contact on deviations. Batch record review for manufacturing.
• SOPs. filling, setups and work on lines, 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
• Perform all activities in compliance with safety standards and SOPs.
• Write, review and approve Standard Operating Procedures in accordance with Policies.
• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.
• Review and approval of Non conformances 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.
• Provides training and advice to staff in order for them to perform their desired functions.
• Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Review and approve cGMP records ensuring compliance with appropriate documentation.
• Support continuous improvement and Operational Excellence initiatives.
Any other tasks/projects assigned as per manager’s request.
• 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.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

Education & Experience

• 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.
• 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.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.