- 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.
- Educated to Degree or Masters Level in a science related subject.
- 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
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Senior Manager R&D Quality - Waterford, Ireland - Teva Pharmaceuticals
Description
Who we are
We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point.
We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.
We would like to invite applications for the role of Senior Manager R&D Quality located at our Waterford site.
The Senior Manager R&D Quality role is part of a team providing Quality Assurance (QA) leadership to the day to day activities of the Research and Development (R&D) and Teva Digital Health (DH) units. This role is involved in working with a dynamic and fast moving R&D Environment and offers the chance to gain a wide range of experience. There is the option for people management as part of this role. This role is desirable for someone who is already a QP or is interested in gaining that qualification.
A Day in the Life of our Senior Manager R&D Quality
Who we are looking for
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