Senior QA Specialist ( Systems & Compliance)

We are seeking applications for a Senior QA Specialist (Systems & Compliance) on behalf of our Client who are a pioneer in the Biotechnology industry. This role will be based in their aseptic drug product operations facility in Dublin and is a senior & active role within the broader QA function.
 
Why you should apply:

• State of the art working facilities, including Next Generation office areas and on-site gym.


• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.

 
 
What you will be doing:

• Develop, review and update engineering, manufacturing, & inspection Standard Operating Procedures.


• Responsibility and oversight for the development and maintenance of site quality processes, quality compliance and auditing related procedures and processes, including but not limited to, Documentation Management, Change Control, Deviation/CAPA processes, Quality Risk Management, Internal auditing/self-inspection program, QMS and the overall Site Management review process.


• Ensures that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site.


• Oversee and maintain site inspection readiness program and for Hosting of inspections (self-inspection and regulatory/corporate inspections).


• Manage inspection outcomes, including inspection response compilation and tracking.


• Oversee and implement Quality Agreements relating to area of responsibility


• Keep abreast of regulatory initiatives and new guidance/requirements and for the communication of revised guidelines.


• Responsible for sustained compliance initiatives, including execution of gap assessments in support of revised Operating Standards and/or Corporate policies & procedures.


• Oversight and Management of Quality Risk Management Processes and for the embedding of QRM principles within the quality framework.


• Ownership, accountability and provision of Subject Matter Expertise for key quality Systems, including Change Control, Deviation/CAPA processes, Documentation Mgmt.


• Responsible for metric programs associated with Deviation/CAPA, Change Control, Periodic Reviews, QRM, ensuring that trend programs and outputs are providing key indicators as to program efficacy.


• Responsible for challenging current procedures and practices, interpretation of trend data and for making any necessary revisions to quality programs to afford optimisation and further development of existing quality standards and overall compliance.

 
What you need to apply:

• University degree in Engineering or Science related discipline preferred.


• Relevant experience working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.


• Excellent written and verbal communication skills


• Experience working with dynamic cross-functional teams and proven abilities in decision making


• Strong organizational skills, including ability to follow assignments through to completion


• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations


• Detailed Knowledge of applicable Regulatory requirements.


• Experience with Regulatory inspections.