Qualified Person
Merck Sharp & Dohme Corp.
Carlow, IE
17d ago

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Enter your email to apply Requisition ID : QUA007671

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.

MSD Carlow are looking to recruit a Qualified Person, to join our existing Quality team on site.

Responsible for ensuring that the process for the manufacture of drug product at MSD Ireland (Carlow) is in compliance with cGMP and the associated regulatory requirements.

  • Responsible for reviewing and approving GMP documentation to support corporate compliance / regulatory expectations for manufacturing operations.
  • Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs.
  • Provision of advice on all aspects of Regulatory GMP practices and systems.
  • Actively participate in Plant / Quality committees and works with other site functional groups, such as the Production and Maintenance to help set direction for GMP initiatives.
  • Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
  • Assist in the proactive evaluation of site compliance against emerging regulatory trends.

  • Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
  • Support the introduction of new products onto site in relation to Quality oversight, covering the end to end product release strategy.
  • Education :

  • Primary degree in a relevant Scientific discipline
  • Must meet the eduicational requirements of a Qualified Person as per EU Directive 2001 / 83 / EC and 2001 / 20 / EC
  • Experience of Sterile manufacture preferred.
  • Knowledge of EU / US quality related pharmaceutical regulations
  • Experience :

  • Minimum of 10 years’ experience in the FDA and / or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and / or manufacturing roles, which includes significant leadership roles with experience in a front-
  • line supervisory role in operations environment.

  • Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics.
  • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level.
  • Proven ability to effectively initiate and drive change across the site.
  • Strong verbal and written communication skills, project management skills.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
  • 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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    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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