Quality Specialist

Orion Group Life Sciences are currently recruiting a Quality Specialist on behalf of our Multinational Pharmaceutical client based in Tipperary on an initial 11-month contract with strong potential to extend.
 
Job description & specific objectives
The Associate Quality Specialist supports day-to-day Quality Assurance activities within a pharmaceutical manufacturing facility. The role operates as part of the Integrated Process Team (IPT), providing quality oversight and ensuring compliance with GMP and regulatory requirements.
The successful candidate will support production operations, quality systems, deviation management, continuous improvement initiatives, and audit readiness activities within a fast-paced manufacturing environment.
 
Position responsibilities

• Participate as the Quality representative within cross-functional IPT teams to support production right first-time initiatives.
• Review and approve batch documentation, cleaning records, and testing documentation.
• Ensure laboratory Out of Specification (OOS) results and process deviations are appropriately documented, assessed, and investigated with associated CAPAs identified.
• Support deviation investigations and process performance monitoring activities.
• Perform trending of deviations and quality events to identify continuous improvement opportunities.
• Provide guidance on quality systems and ensure root causes are identified with effective corrective and preventive actions implemented.
• Support validation activities and provide quality input into process and product risk assessments.
• Identify recurring issues and drive improvements to systems and processes.
• Ensure change controls are appropriately raised, documented, assessed, and completed.
• Prepare and support Annual Process Reviews and System Reviews.
• Participate in internal GMP audits and walkdowns as lead auditor or audit team member.
• Support the generation and communication of quality metrics.
• Create, review, and approve quality procedures and related documentation as required.

Competencies:
Communication

• Strong written and verbal communication skills.
• Ability to organize and communicate information effectively across departments.

Teamwork

• Works collaboratively within cross-functional teams.
• Willingness to share information and contribute positively to team objectives.

Decision making

• Uses sound judgement and analytical thinking to support quality decisions.

Adaptability

• Comfortable working in a changing and fast-paced manufacturing environment.

Work standards

• Maintains high standards of accuracy, compliance, and attention to detail.

Motivation

• Demonstrates initiative, enthusiasm, and accountability in daily responsibilities.

 
Qualifications, skills & experience
 
Education

• Degree or postgraduate qualification in Science, Pharmacy, or a related discipline.

 
Experience & knowledge

• Previous experience within a Quality role in pharmaceutical manufacturing desirable.
• Knowledge of GMP requirements within regulated manufacturing environments.
• Experience with quality systems such as SAP and Trackwise desirable.
• Experience working within electronic or paperless manufacturing systems advantageous.
• Lean / Continuous Improvement knowledge beneficial.
• Spray drying experience desirable.
• Experience within high potency manufacturing environments advantageous.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.