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QA Manager

The Company:

A biopharmaceutical company in Dublin focused on improving patient's lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. Core values include Growth, Accountability, and Transparency.

What you will be doing:

The manager will work closely with internal technical operations functions of manufacturing and supply chain, and will be a key member of the cross functional product team for their product portfolio

  • QA SME for all aspects of quality operations for product portfolio
  • Lead QA oversight at contract manufacturers and 3rd Party Laboratories
  • Review contractor batch records, deviations and change controls to ensure that they comply with cGMP and regulatory dossier
  • Drive the execution and approval of investigations, change controls, CAPAs, and validations
  • Investigation of product complaints
  • Provide final release for distribution where required
  • Trend and monitor of quality control data
  • Monitor and report quality metrics pertaining to the quality operational activities

This role requires good judgement and strong initiative. You need to have the ability to effectively prioritise and manage a diversified workload, often to strict deadlines. You should have strong interpersonal skills, a professional approach with excellent written and verbal communication skills.

Requirements:

  • Primary degree in a science discipline
  • 5 years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
  • Experience working with contract manufacturing organisations or a virtual environment is desirable
  • Excellent communication skills and an ability to partner effectively with internal and external partners
  • Ability to travel internationally as required

Benefits:

Health Care

Pension

Bonus

For immediate consideration apply with an up to date CV.

No CV ready? Not sure yet? Please get in touch for more info.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales