QA Manager

LSC have a great contract opportunity for a QA Manager to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.

If you have 10+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

• Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
• Negotiator and Approver of quality agreements
• Lead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
• Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas
• Review / Approve Master Batch Records
• Quality approver for deviations, change controls, CAPA
• Prepare inspection playbooks

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Familiarity with basic project management tools
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results

Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding.

Apply via this advert or contact Grainne Hodnett on 021 4777 329 if you have any more questions about this opportunity!