Compliance Document Specialist
Merck Sharp & Dohme Corp.
Munster, Ireland
26d ago


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.

The Compliance Documentation Specialist is accountable for the smooth execution of all appropriate functions associated with the Supply Chain Management.

The Compliance Documentation Specialist will assure that Supply Chain Management activities are performed to a defined and benchmarked standard and in compliance with all site, corporate and regulatory expectations, that there is a process for monitoring and continuous improvement.

He / She will contribute to the High Performance culture within Supply Chain Management by providing a flexible, accurate service to enable the department to achieve our Manufacturing Division four key priorities.

He / She is an active member of the Supply Chain Management team providing support, guidance and expertise.

The Compliance Documentation Specialist will participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant to you.

Primary Activities / Responsibilities :

  • Provide on-going technical assistance to support Warehouse, Logistics and Planning procedural updates, change control documentation and other general compliance related activity.
  • Preparation / approval / and issuance of procedural and change control documentation within timelines.
  • Ensure compliance with cGMP and other business compliance regulations.
  • Department NOE, CAPA & ITR tracking and closeout co-ordinator, NOE trend reports, CAPA’s, deviations and change control documentation.
  • Participate in cross functional teams to ensure that Supply Chain Management and site goals are achieved.
  • Training scheduling, tracking & maintenance of training matrices
  • Compilation and verification of databases and report generation as required, including Kronos attendance system.
  • Support a culture of Continuous Improvement by deploying MSD Six Sigma tools within the Supply Chain Management
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