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Senior systems quality assurance expert

Dublin
beBeeQuality
Posted: 31 July
Offer description

Job Title: Senior Systems Quality Assurance Expert

Description:

We are seeking a skilled Senior Systems Quality Assurance Expert to join our Dublin team. The successful candidate will be responsible for the development and maintenance of site quality systems, ensuring sustained compliance initiatives and effective implementation of quality programs.

Key Responsibilities:

* Develop and maintain site quality systems, including documentation management, change control, deviation/CAPA processes, and oversight of QMS systems.
* Provide quality direction and input at Change Control and Deviation Review Boards, ensuring scope and implementation activities are robust and timely.
* Oversee and implement quality agreements relating to area of responsibility.
* Stay up-to-date with regulatory initiatives and communicate revised guidelines associated with quality systems.
* Responsible for gap assessments, execution of operating standards, and corporate policies & procedures.
* Oversight and management of Quality Risk Management (QRM) Processes, embedding QRM principles within the quality framework.
* Ownership and provision of Subject Matter Expertise for key quality systems, including Change Control, Deviation/CAPA processes, and Documentation Management.
* Responsible for trending programs, interpretation of trend data, and making revisions to quality programs to optimize existing standards.

Requirements:

* University degree in Engineering or Science related discipline preferred.
* Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry.
* Experience working in aseptic operations, protein formulation, vial and syringe filling.

Location: Dublin, Ireland

Benefits:

This role offers opportunities for professional growth and development in a dynamic work environment.

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