About the Project
Leverage your expertise in quality management to drive sustained compliance initiatives in a fast-paced biopharmaceutical environment. As a Quality Specialist, you will provide strategic direction and input at Change Control and Deviation Review Boards, overseeing change control and Deviation/CAPA records.
* Provide quality direction and input at Change Control and Deviation Review Boards
* Oversight of change control and Deviation/CAPA records ensuring scope is clear and implementation activities are robust and timely
* Oversee and implement Quality Agreements relating to area of responsibility
* Keep abreast of regulatory initiatives and new guidance/requirements and communicate revised guidelines associated with Amgen Quality Systems
* Responsible for sustained compliance initiatives including execution of gap assessments in support of revised operating Standards and/or Corporate policies & procedures
* Ownership accountability and provision of Subject Matter Expertise for key quality Systems including Change Control Deviation/CAPA processes and Documentation Management
About You - Are Your Skills a Match?
With 8+ years of experience working in the pharmaceutical or biotechnology industry, you will leverage your problem-solving skills and manage Root Cause Analysis/Deviation investigations. A detailed knowledge of applicable regulatory requirements and experience with Regulatory inspections are essential.
* Demonstrated ability in problem solving and experience in managing Root Cause Analysis/Deviation investigations
* Detailed Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections
* Experience working in aseptic operations protein formulation vial and syringe filling
Applicants interested in contracting opportunities within the pharmaceutical sector in Ireland require a Stamp 1 G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship.