Overview
Quality Assurance Specialist position at MSD in our R&D facility in Dunboyne. You will report to the Associate Director of QA Operations within Global Development Quality (GDQ). The QA Specialist shift role will support the Quality Assurance activities at the Dunboyne facility. The QA Specialist is a key member of the quality team ensuring the site has a strong operational compliance focus aligned with the principles and expectations of cGMP regulations. The QA Specialist will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The QA Specialist will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. The QA Specialist will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required.
This is a shift position.
Responsibilities
* Participate daily on cross-functional teams to collaboratively actively to address compliance issues.
* Participating in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
* Provide QA oversight to the 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 the performance of detailed review of eBR 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, SOP’s and reports in line with site requirements.
* Support an environment 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 and compliant culture.
* Participate in and support risk management activities in line with relevant guidance and best industry practice.
* Ensures the escalation of compliance risks to management in a timely manner.
Qualifications
* 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 Manager capability with significant understanding of Operations and Laboratories.
* Demonstrated experience in QRM, Investigations, 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 in quality management systems such as Veeva, SAP, PAS-X etc.
* Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
* Experience in direct interactions with regulatory agencies during site inspections.
About MSD
As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
If you are ready to Invent solutions to meet unmet healthcare needs, impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Requisition ID: R358930
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