Quality Systems Specialist

The role:

PE Global is currently recruiting for a Quality Systems Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.

Responsibilities:

• The QA Specialist will be responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements.
• Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.
• Partner with colleagues cross functionally/ on and off site to provide support and advice on day-to-day basis and on a project, basis including communications, training, project work, audit/inspection duties, investigations, systems compliance etc.; thereby ensuring department/site is audit/inspection ready.
• Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements.
• The role will support quality systems activities and will liaise with site to ensure systems are maintained and compliant as per global and local procedures.
• Responsible for helping to ensure that the quality systems in use on site maintains complaint status.
• Act as quality support for site for relevant systems
• Ensure that quality issues are identified, addressed and resolved in a timely manner.
• Responsible for supporting issue close out on site and initiating/following up on corrective and preventative actions and continuous improvements.
• Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations etc

Education and Experience:

• Bachelor Degree or higher preferred; ideally in a related Science discipline
• Demonstrated ability in quality systems support
• Knowledge of EU/US quality related pharmaceutical regulations
• Experience of Sterile manufacture preferred
• The ideal candidate will have 3 – 5 years’ experience in a pharmaceutical/ regulated background with strong working knowledge of regulatory expectations, aseptic processing, environmental and utility monitoring in a sterile manufacturing facility.
• Report, standards, policy writing skills required
• Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems)
• Lean Six Sigma Methodology experience desired

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***