QA Specialist – Cork, Ireland

12 month contract

An opportunity has arisen to work for one of the largest Pharmaceutical companies in the world, to work as a QA Specialist to be based in Cork on a 12 month contract opportunity. This position would sit within the Quality function for their biologics business department, where the successful person would be responsible for activities including batch release, change control, event management, supplier qualification and validation compliance. This position would provide support for all departments in relation to all the quality systems in place currently.

Other responsibilities include:

• Batch Record Review & material release to ensure compliance with GMP requirements.
• Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
• Carries out tasks related to the management of batch records design and approval.
• Carries out administration of the Quality Management Module.
• Carries out tasks relating to the management of site change control systems.
• Compiles Annual Product Reviews.
• Supports all validation activities on site
• Supports system qualification and process validation activities.
• Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
• Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
• Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
• Perform GMP audits on-site and vendor facilities as required.

Experience needed:

• Previous experience in working in a Quality Assurance role
• Strong GMP experience and previously working in a manufacturing environment
• Excellent communication skills both written and verbal.
• Right to work in the EU at time of application

Apply Now

You can apply for this role by sending us your CV or by calling us now!

James Brookes

Contact: 0203 545 1103 or email j.brookes@hamlynwilliams.com.

We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you.

You can learn more about me by looking me up on LinkedIn. Search for James Brookes https://www.linkedin.com/in/jamesbrookeshw/