Quality Systems and Compliance Manager

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The Quality Systems and Compliance Manager is responsible for managing the Quality Systems and Compliance area at their site in Dublin. The role is responsible for management of all GMP Quality Systems and ensuring compliance to cGMP for all manufactured products including API, oral solid dosage product and biologics.

The Quality Systems and Compliance Manager will work closely with other Quality Department personnel as part of the site Quality Department.

Responsibilities:

* Ensuring site quality systems comply with changing requirements and trends in worldwide GMPs.

* Management of TILGC GMP quality systems including the following:

* Change Control

* Document Management

* Deviation Management

* CAPAs

* Vendor and Service Supplier Management

* Customer Complaints

* Product Return

* Product Recall

* Annual Product Review

* Management of site auditing activities, including regular self-inspections, annual internal auditing and auditing of GxP vendors and service suppliers.

* Managing the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

* Preparation, review and approval of GxP documentation, including SOPs, policies, analytic documentation, manufacturing documentation and material specifications.

* Incorporation of global standards and procedures into site Quality Systems.

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Preparation and approval of GxP training materials and delivery of training for new hires and existing personnel

* Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement

Experience:

* Minimum of 10 years experience in the pharmaceutical industry in a Quality role

* Minimum of 3 years' experience in a people management role

* Minimum of 5 years' experience in working in an aseptic manufacturing facility

* Experience in manufacture of biologics is also required

This is an opportunity to join their select team that is already leading the way in the Pharmaceutical/Biotech industry. For immediate consideration please apply below with an up to date CV. Not sure yet? No CV ready? Give me a call on 01-8883477 for more information

Sthree UK is acting as an Employment Agency in relation to this vacancy.