Senior Quality Specialist

PE Global are currently recruiting for a QA Senior Associate shift for a client site in South Dublin.

QA Senior Associate (3 cycle shift)
12 Month Contract

Overview:

The Quality Assurance (QA) Senior Associate will report to a Senior Quality Manager and is a core member of the site Quality Assurance team. The Senior Quality Specialist will serve as Quality point of contact for Packaging operations, as well as back up support the complaint’s function.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, Senior Quality Specialist may be asked to carry out additional work functions to support site continuous improvement activities.

Current shift pattern is 24/5, with a 25% shift premium will apply.

Key Responsibilities:

• Perform all activities in compliance with safety standards and SOPs
• Observe and provide real-time Quality oversight and support for Packaging unit operations.
• Perform Finished Pack Quality audits- “Pack checks”, on each finished labelled and packaged lot during batch operations.
• Decision maker on classification of defective units found during combination product assembly, and labelling and packaging processes in accordance with the on-site defect manual
• Provide Quality support for triage of atypical events during production. Guiding the cross functional work centre team on the rationale for continued operation and appropriate next steps to ensure product Quality requirements are met
• Perform Quality oversight of minor deviations, ensuring compliance with appropriate documentation.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Provide training and advice to staff in order for them to perform their desired functions.
• Write, review, and approve Standard Operating Procedures.
• Support continuous improvement and Operational Excellence initiatives
• Participates in Customer complaint investigations by virtue of completion of complaints based retrospective batch record review, and also as a team member in Cross functional Root cause analysis investigations
• Any other tasks/projects assigned as per manager’s request.

Qualifications & 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.
• Experience in the QA department for 2+years
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience working with combination products or devices in packaging-related or complaint-handling activities
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

Interested candidates should send their CV to sean.fitzsimons@peglobal.net or call 0214297900