Lead QA Auditor
Merck Sharp & Dohme Corp.
Carlow, IE
17d ago

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Enter your email to apply Requisition ID : QUA007672

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-

year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide.

Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

At MSD Carlow we are hiring a Lead QA Auditor to join our existing Quality team on site.

  • Responsible for ensuring that the process for the manufacture of Vaccines and Biologics are in compliance with cGMP and the associated regulatory requirements.
  • Responsible for ensuring that there is an effective Quality Management System is in place.
  • Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.
  • Lead proactive evaluation of site compliance against emerging regulatory trends.
  • Ensure that quality issues are identified, addressed and resolved before activities commences.
  • Responsible for supporting deviation and atypical close out and initiating / following up on corrective and preventative actions.
  • Be an advocate of continuous improvement in the Quality Management Systems.
  • Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
  • Represent the sites Quality Management System during Board of Health and other GMP inspections
  • Lead and perform internal audits (system and walkthrough) at the MSD site.
  • Maintain current technical, compliance, regulatory, and audit skill knowledge to ensure audit program effectiveness through identification of early compliance warning signals.
  • Perform audits at regional MSD sites, and host regional guest auditors (as applicable). Lead by example and apply cutting edge, risk-
  • based audit techniques.

  • Effectively communicate audit / inspection results to stakeholders and site leaders. Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for audits & inspections for complete remediation.
  • Support the preparation and hosting Health Authority inspections and Divisional GMP Audits. Generate and report metrics / trends for program adherence to requirements and effectiveness.
  • Qualifications

    Qualifications and Experience :

  • Third Level Degree qualified in a Science / Technical or related discipline.
  • 5 years experience in a similar role in the Pharmaceutical industry managing teams.
  • Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable to the site.
  • Subject Matter Expertise , including knowledge and demonstrated application in one or more of the following areas, based on site activities;
  • Medical Device / Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product

  • GMP Audit experience in the Pharmaceutical industry
  • Experience with leading and performing effective audits and obtaining meaningful audit observations
  • Problem-solving / critical thinking ability to understand connections between different technical / quality system areas and recognize potential compliance issues
  • Communication, decision making, people influencing and project management skills will be important.
  • Critical to success will be an expert level of knowledge of cGMP and Quality System regulations as they pertain to all aspects of the Carlow site.
  • Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.

    At MSD, we’re inventing for life.

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