Quality Specialist

Orion Group Life Sciences are currently recruiting a Quality Specialist on behalf of our Multinational Biopharmaceutical Client based in Tipperary on an initial 11-Month contract with potential to extend
 
The Quality Specialist role:

• Participate as functional expert in the cross functional team that manages

production right first time at site.

• Review and approve batch, cleaning and testing documentation.
• Ensure that all Laboratory Out of Specification (OOS) and process deviations are

documented, assessed and associated CAPA identified.

• Provide support to deviation investigations and process performance monitoring.

Perform trending on deviations raised as required to identify improvement
initiatives.

• Provide detailed knowledge of quality systems in place and ensure that root cause is

identified and corrective actions as appropriate are completed.

• Provide guidance on quality requirements to maintain validation status, including

participation in process/product Risk Assessments.

• Provide feedback on re-occurring issues ensuring continuous improvement to

systems/processes.

• Ensure changes controls raised are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Act as lead/team auditor to support the internal GMP walkdown and scheduled

audits.

• Participate in the generation and communication of quality metrics.
• Creation, review and approval of quality procedures as required.

 
What skills you will need:
In order to excel in this role, you will more than likely have:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free

operations.

• Experience in High potency manufacturing desirable.
• Communications: Excellent written and oral communication skills. Organizes and

delivers information appropriately.

• Team Work: Interacts with people effectively. Able and willing to share and receive

information.

• Decision Making: Uses sound judgement to make good decisions based on

information gathered and analysed.

• Adaptability: Adapts to changing work environments, work priorities, organizational

needs and diverse people.

• Work Standard: Sets and maintains high performance standards. Pays close

attention to detail, accuracy and completeness.

• Motivation: Displays energy and enthusiasm. Maintains high level of productivity

and self direction.


People are our business worldwide
 
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.