Quality , Science, Pharmaceutical & Food

QA Specialist – Complaints

  • Contract
  • Remote
  • Dublin South
  • 41936050

PE Global are currently recruiting for a QA Snr Associate – Complaints for our Bio client site in South Dublin:

12 Month initial contract


The Quality Assurance (QA) Snr Associate will report to a Snr QA Manager and is a core member of the site Quality Assurance team. The QA Snr Associate will serve primarily as a Quality point of contact for batch record review for complaints received related to products manufactured and packaged at our facility. The Senior associate will also be expected to cross train to support on the floor packaging operations in a limited capacity.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, QA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
The role is primarily site based, but there is a possibility to work from home 1-2 days a week, where business needs allow it. Days role.

Key Responsibilities:

• Perform all activities in compliance with safety standards and SOPs
• Review production batch records, and associated documentation in support of complaint investigations
• Document assessments within the complaint repository Bioconnect for batch records, root cause analysis (RCA) outcomes, technical evaluations related to complaints
• Support Area SMEs during complaints RCA, technical evaluation by providing them with context of the complaint received within the Bioconnect system
• Complete DV on the monthly complaints report.
• Provides training and advice to staff in order for them to perform their desired functions. Specifically on complaints batch review and also on navigation of the Bioconnect system within our facility for other QA teams and external functions who support complaints
• Support audits and inspections through collation and data verification of complaints data for presentation to auditors
• Write, review and approve Standard Operating Procedures in accordance with Policies.
• Observe and provide real-time Quality oversight and support for Packaging unit operations.
• Perform Packaging check quality audits during production of Labelled and Finished Drug Product lots.
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

Basic 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.

Preferred Qualifications & Experience:
• Experience working with combination products or devices in packaging-related or complaint-handling activities
• Experience in using the following electronic systems, or an equivalent, as part of batch record review: SAP, Werum PAS/X Manufacturing Execution System (MES), Trackwise.
• 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 and work independently
• Experience as a participant in Root Cause Analysis / Deviation investigations
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience 


Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV audrey.mccarthy@peglobal.net


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



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