Quality Technician – QA Specialist

The Innopharma Group; Ireland; On-site; EUR 42,000 - 68,000; Full time

Job summary

Innopharma Group's Innopharma Technical Services is seeking a Quality Assurance Specialist to support QA activities within our bio/pharma manufacturing environment in Leinster. The role reports to the Quality Manager and is shift-based and onsite.

The successful candidate will review batch documentation, investigations, and reports; ensure cGMP compliance; work with SAP, Trackwise and MES; and collaborate across functions to maintain high quality standards.

Qualifications

• Bachelor's degree in Science (or equivalent)
• 1-2 years’ experience in a quality role in a pharmaceutical manufacturing facility (aseptic preferred)
• Working knowledge of Irish/EU/International regulatory requirements
• Knowledge of cGMP and GDP
• Experience with quality systems and document control

Responsibilities

• Review batch documentation, investigations and reports and assist in issue resolution
• Respond to unplanned events and technical issues promptly
• Maintain audit readiness and cGMP compliance through active quality control activities
• Support production lines and spot-check/walk-through processes
• Collaborate cross-functionally to promote GMP improvements and regulatory compliance

Skills

Quality systems

Documentation

Regulatory knowledge

Team collaboration

Education

Bachelor's Degree in Science

Tools

SAP

Trackwise

MES

Job description

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