Quality Technician - QA Specialist

Innopharma Technical Services, part of Innopharma Group, specialises in the training and recruitment of highly skilled, project-ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are supporting a global life sciences client in the province of Leinster with the appointment of a Quality Assurance Specialist.

About the position:

The Quality Assurance Specialist will support the activities related to QA within the company. This position will report to Quality Manager.

The position is shift based & onsite.

Key Responsibilities:

The Quality Assurance Specialist is required to:

• Technical knowledge of sterile manufacturing processes.
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk.
• Respond quickly to unplanned events, technical issues.
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
• Support the spot check/walk-through process of the production lines.
• Involved in customer complaint investigation if required.
• Work well cross functionally and be an active team member.
• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding of sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation (EBR's)/ line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards.
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

Preferred Experience:

• Minimum Level 8 Bachelor's Degree or higher preferred in a Science discipline.
• 1-2 years' experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing.
• Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required.
• Previous experience in a quality function or in an aseptic environment is beneficial.

Note:

• It is a shift-based role - 4 cycle, 12 hours per shift with a shift allowance of 33%
• Due to the nature of the business, additional duties may be required/assigned from time to time.
• All applicants must be eligible to work in Ireland.

INNOPHARMA, RAVENSCOURT BUSINESS PARK, THREE ROCK RD, SANDYFORD, DUBLIN 18, D18 K599, IRELAND