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Quality Manager

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 13th August
Location: Dublin
Type: Permanent
Start Date: ASAP

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Biopharmaceutical company who have ambitious plans have an exciting opportunity for a permanent full time Quality Manager based at their Dublin office.

The Company

Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.

The company has a portfolio of medicines through its orphan and inflammation groups. The companies global headquarters are in Dublin, Ireland. The company also has offices in the US and Europe.

The Position

The Quality Manager is responsible for providing quality assurance management of contract manufacturers and 3rd party laboratories and for assuring that the products supplied to our patients are manufactured and tested in accordance with cGMPs and the regulatory dossier.

As part of the quality operational team, the manager will be responsible for the quality operational activities for their specific product portfolio. They are responsible for ensuring the highest quality standards by managing the operational quality system elements of deviations, CAPAs, change controls and product complaints. The manager will also be responsible for the release for distribution for their specific product portfolio where required.

This positon 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.

Responsibilities

  • 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 and Provide final release for distribution where required

Qualifications and Skills Required:

  • Primary degree in a science discipline, with an excellent understanding of quality assurance
  • 5 years pharmaceutical experience with at least 3 years in a QA/QC position supporting pharmaceutical production and/or testing
  • Knowledge of QA for all pharmaceutical dosage forms and drug substance manufacture for both large molecule and small molecule is desirable

Package: Competitive salary, pension, health an dental and bonus among other benefits

For immediate cosideration please apply with an up to date CV. Not sure yet no CV ready please get in touch.

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