QA Ops Specialist

Orion Group Life Sciences are currently recruiting a QA Ops Specialist on behalf of our Multinational Biopharma Client based in Meath on an initial 11-Month contract with potential to extend.

Shift position will have a rotation of working days across 7 days max working week 40hours - start and end time will vary depending on shift.

Responsibilities:

• Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner.
• Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented to meet deadlines.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations.
• Perform material disposition of incoming material to the site.
• Assist in the development of training curricula and records for the QA Operations group, providing SME training on Quality Assurance SOPs as required.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Ensure the escalation of compliance risks to management in a timely manner.
• Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
• Support cross functional departments by responding to quickly to unplanned events and technical issues.
• Perform real time exception review by maintaining on the floor operations support during manufacturing.
• Support the site’s walk-through/ GEMBA process as assigned.
• Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.

Education/Experience

• Degree qualification (Science/Quality/Technical). 
• 4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. 
• Experience with PAS-X, SAP and Veeva is desirable.
• Project Manager capability with significant understanding of Operations and/or Laboratories. 
• Demonstrated experience in QRM, Investigations, problem solving as a Quality SME. 
• Strong written and verbal communication skills. 
• Ability to think logically and be proactive under pressure. 
• Ability to work as part of a team and on own initiative in a constructive manner. 
• Strong attention to detail and precision in preparing and reviewing GMP documentation. 
• Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Experience in direct interactions with regulatory agencies during site inspections. 

 


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