QA Specialist

Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist (Shift) on behalf of our Multinational Pharmaceutical client based in Carlow on an initial 11-month contract with strong potential to extend.
 
This is a shift position – 4 cycle  12 hours per shift e.g.

• Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights
• Week 2- short week: Wed and Thurs Days,
• Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
• Week 4: short week: Wednesday and Thurs Nights   

• Shift premium is 33%

 

• The position is onsite and remote or hybrid is not applicable for this role,
• For the job shift experience, working in a quality function or in an aseptic environment is beneficial

 
The Quality Assurance Specialist within Our Company 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 e.g. 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

 
POSITION RESPONSIBILITIES

• 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.

 
REPORTING STRUCTURE
Reports to Quality Manager
 
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
Skills and Knowledge
Typical Minimum Education

• Bachelor’s Degree or higher preferred in a Science discipline

Typical Minimum Experience

• 1-2 years’ experience in a Quality Role at pharmaceutical manufacturing
  facility preferably aseptic manufacturing
• Experience in SAP, MES, Trackwise desirable

 
Technical
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
• Competent in the use of MES and SAP

 


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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.