Plant QA Snr Associate


Level 4


Dun Laoghaire

Overview:


The Plant Quality Assurance (PQA) Snr Associate will typically report to a QA Senior Manager and is 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.


A variety of shift patterns may be required to support manufacturing operations, including but not limited to day shift, 16/5 shift, 24/5 shift and 24/7 shift. Weekend work may also be required. This is a 9 month assignment, to cover increase of work load to start immediately.

This is a shift role, 1 week earlier, 1 week late (Mon to Thurs: 0700 - 1500, Fri: 0700 - 1400, Mon to Thurs: 1430 - 2230, Fri: 1330 - 2030)

Candidates need to have a pharma/manufacturing background circa 3 years +
Problem solving ability

Key Responsibilities:

• Perform all activities in compliance with site safety standards and SOPs
• Write, review and approve Standard Operating Procedures in accordance with site Policies.
• Participates in customer complaint investigations.
• Provides training and advice to staff in order for them to perform their desired functions.
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Support continuous improvement and Operational Excellence initiatives
• Any other tasks/projects assigned as per manager’s request.

• Provide Quality support for triage and investigation of all classes of non-conformance (NC) events
• Review and approval of NC1s and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable

• 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.
• Perform Visual Inspection AQL inspections and provide quality oversight for the inspection program

• Review and approve cGMP records (e.g., NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation

• 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 / 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
• Operational Excellence experience