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QA Specialist

  1. Ireland, Midlands (Ireland)
Carlow
  1. Permanent
Competitive
  1. Commissioning, Qualification and Validation
34614
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QA Specialist - Pharmaceuticals - Carlow, Ireland - 11-Month Contract 

Do you want to be involved with exciting Pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a QA Specialist.

This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.


Role Summary:
  • 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.
  • 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. 

Requirements:
  • Bachelor’s 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
  • Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality system role
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics
  • Proven ability to effectively initiate and drive change
  • Strong verbal and written communication skills, project management skills
  • 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
  • Good Collaboration Skills
  • Ability to work as part of a team to determine priorities
  • Demonstrated ability to work independently and fully realise improvement initiatives with a moderate level of guidance


If this role is of interest to you, please apply now! 

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