Overview
Quality Assurance Specialist role at MSD Ireland, based at our R&D facility in Dunboyne (Dublin area). You will report to the Associate Director of QA Operations within Global Development Quality (GDQ). The QA Specialist shift role supports quality assurance activities at the Dunboyne facility. The role ensures the site maintains a strong operational compliance focus aligned with the principles and expectations of cGMP regulations. The QA Specialist maintains cGMPs for assigned areas in conformance with policies and regulatory requirements in an FDA/EMEA regulated environment. The role provides quality support to the site, including training and guidance on the interpretation and implementation of company guidelines/policies and regulatory requirements.
This is a shift position.
Responsibilities
* Participate daily in cross-functional teams to collaboratively address compliance issues.
* Participate in investigations and risk assessments related to deviations, complaints and changes, ensuring appropriate actions are implemented in a timely manner.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation to ensure GMP compliance and site requirements at the start-up facility.
* Provide QA oversight to qualification/validation, technical transfers, regulatory approvals, laboratory operations and commercial operations at the start-up facility.
* Complete QA operational duties related to product disposition, including detailed review of electronic batch records prior to QP release.
* Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
* Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements.
* Support a culture of continuous improvement by identifying and implementing efficiencies and quality improvements.
* Work collaboratively to foster strong relationships with management and colleagues and to drive a safe, compliant culture.
* Participate in and support risk management activities in line with relevant guidance and industry best practice.
* Escalate compliance risks to management in a timely manner.
What Skills You Will Need
* Degree qualification (Science/Quality/Technical).
* 4-7 years’ experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Project management capability with significant understanding of Operations and Laboratories.
* Demonstrated experience in Quality Risk Management (QRM), investigations and problem solving as a Quality SME.
* Strong written and verbal communication skills.
* Ability to think logically and be proactive under pressure.
* Ability to work as part of a team and on own initiative in a constructive manner.
* Strong attention to detail and precision in preparing and reviewing GMP documentation.
* Experience with quality management systems such as Veeva, SAP, PAS-X, etc.
* Demonst-rated knowledge and application of industrial regulations including FDA, HPRA, EMEA and other authorities related to biologics and/or pharmaceuticals.
* Experience in direct interactions with regulatory agencies during site inspections.
As a company, we are committed to inventing for life and placing the patient at the heart of all we do, striving to find solutions for healthcare needs.
If you are ready to invent solutions to meet unmet healthcare needs and to contribute to one of the world’s leading healthcare companies, please apply today.
Location: Dunboyne, County Meath, Ireland.
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