Teva Senior Manager R&D Quality 

Ireland 

666301775

We would like to invite applications for the role of Senior Manager R&D Quality located at our Waterford site.

• Reporting on the performance of the quality system, reviewing and approving batch documentation, investigation reports, change requests, SOP’s, qualification reports and ensuring they are completed right first time and in full in accordance with Good Manufacturing Practice requirements
• To develop, maintain, implement and improve quality standards and systems which give assurance that products comply with clinical dossiers, specifications and cGMP’s. To take ownership where needed
• Responsible to support clinical trial batch release / new product submissions / launch.
• Carrying out audits to ensure that all operational processes are in compliance with the required standards conforming to Company GMP, GLP, SOP’s, Specifications, Clinical/Submission dossier/ Technical Documentation requirements. Auditing of vendors/suppliers/CMO’s as required.
• Ensuring that the quality system requirements are effectively established and efficiently maintained in accordance with the regulations.

Are you….

• Educated to Degree or Masters Level in a science related subject.

Do you have?

• Extensive experience in Quality Assurance/Quality Auditing at senior level.
• Extensive R&D experience in an FDA / HPRA approved facility.
• Expertise in regulatory requirements with respect to at least one of Pharmaceutical / Medical Devices / Combination Products
• Qualified Person status/eligibility is preferable.
• Knowledge of cGMP, GLP, Regulatory Bodies and Customer requirements
• Decision making experience
• Planning & Organising Skills

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.