Your new company

Here at Hays we have an outstanding contract opportunity for a Quality Assurance Specialist with our client, a research-based biopharmaceutical company based Cork city. This position would be based with an established industry name that specialises in the discovery, development, and commercialisation of innovative medicines for areas of unmet medical need. Some of their main therapeutic areas of focus would include liver diseases, cancer and inflammation, and severe respiratory and cardiovascular conditions.

The role would situated QA Department under the QA packaging and labelling support team and required to perform QA approval and release of primary and secondary packaging components, QA review and approval of packaging and labelling documents, procedures, and GMP deviations for the client.

• Perform a wide variety of activities to ensure compliance with applicable cGxP regulatory requirements.
• Participate in developing Standard Operating Procedures and writes and/or implements changes to controlled documents to ensure quality objectives are met.
• Participate in reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
• Perform QA review and release of primary and secondary packaging components.
• May participate in QA review and approval of artwork.
• Identify deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
• QA Review and approval of GMP Deviation investigations and CAPAs
• QA Review and approval of Master data and recipes required for operations
• Participate in compliance improvement projects involving cross functional teams.
• Assist with compliance audits and walkthroughs as required on behalf of the QA department to ensure site compliance to GMP.
• Maintain programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

What you'll need to succeed

• 3+ years of relevant experience in a GMP environment related field and a BS
• Prior experience in pharmaceutical industry is preferred (ideally within a QA role) or as a Secondary Packaging
• Demonstrates proficiency in Good Manufacturing Practices (GMPs).
• Demonstrates proficiency in application of QA principles, concepts, industry practices and standards.
• Demonstrates working knowledge of FDA / EMEA standards and quality systems.
• Demonstrates basic knowledge of OPEX Lean tools and root cause analysis tools used for identifying and correcting deviations.
• Demonstrates audit and investigation skills, and report writing skills.
• Demonstrates good verbal, technical writing and interpersonal skills.

What you'll get in return

• Opportunity to gain unique and valuable experience within an in-demand skillset for an leading company

• Excellent chance to progress one's career quickly in the most exciting forward-thinking space of biological drug development.

• Sick-pay and bank holiday coverage

What you need to do now

If you're interested in this role and would like to know more click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.

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