QC Vaccines Manager
Merck Sharp & Dohme Corp.
Carlow, IE
18d ago

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Enter your email to apply Requisition ID : QUA007059

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 Carlow offers a fantastic opportunity for a QC Vaccines Manager interested in leading a team to execute analytical testing of our Vaccines products in a cGMP regulatory environment.

This QC Manager will lead a team of analysts, senior analysts and specialists and hence will be responsible for people aspects, such as coaching, talent development, recruitment and performance management.

We are looking for a QC Vaccines Manager who will report directly to the Associate Director of Quality and who will play a pivotal role in the start up of our new QC lab.

The ideal candidate will have approximately 5 years experience in a senior supervisory or managerial Quality focussed role and have an analytical background.

This is a critically important role to ensure efficient, effective and compliant lab operations are embedded from the start, using lean methodologies.

The successful manager will provide technical expertise, trouble-shooting, training and support to the junior members of the team and in addition, will liase with technical subject matter experts from other MSD sites as well as participate in above site analytical and technical forums.

Responsibilities :

  • Manage a team of analysts, senior analysts and specialists ensuring that all regulatory requirements are met.
  • Leadership activities including selection, development, coaching and day to day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills.
  • Provide technical guidance and apply expertise and critical thinking to help to resolve technical and compliance issues.
  • Assist in the review of accurate lab operational procedures, training materials and procedures for various systems.
  • Facilitate the daily team meeting and ensure team representation at required cross functional forums.
  • Participate in the review and update of SOP’s, trend data, investigations, non-conformances, validation protocols, reports, method validation / verifications and equipment Qualifications
  • Assist in the review of data for periodic reviews as required.
  • Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.
  • g. FMEA, Fishbone diagrams, 5 why's etc, all under aseptic / clean room conditions. Provide input, review and approval for atypical, observation, and process capability investigations.

    Oversee coordination of resources to implement suggestions / ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.

  • Manage and contribute to the achievements of department productivity and quality goals
  • Provide support with audit / inspection requirements to ensure department compliance / readiness. Participate in internal and external audits and inspections, taking the role of auditee / auditor for assigned areas of responsibility.
  • Minimum Education :

  • Third level qualification (Degree) in a science related discipline, ideally in Chemistry or Analytical Chemistry.
  • Minimum Experience :

  • 5 years of experience in a supervisory or managerial role in a Pharmaceutical Laboratory.
  • Considerable analytical expertise and technical troubleshooting skills.
  • Initial Travel Requirements :

  • Only very occasional travel may be required.
  • 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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