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Senior Manager QC Support

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 27/03/2018
  • Job reference: J382319A

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Senior Manager QC Support

Our client, a leading Biopharmaceutical organisation is currently seeking a Senior Manager QC Support to join their expanding team. In this position you will be responsible for the oversight of QC equipment maintenance program, and all QC inputs into the quality system including investigations, deviations and change controls.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Oversight of QC equipment lifecycle activities (including procurement, installation, qualification, maintenance, and decommissioning).
  • Provide direction to Managers and staff that support the Equipment
  • Ensures Equipment qualification and maintenance programs are compliant with regulatory agencies requirements, qualified and available for QC laboratory usage.
  • Interact with QC partner groups to establish internal requirements for Equipment.
  • Lead QC equipment validation / qualification efforts through partnering and interaction with QA-Validation and IT groups.
  • Oversight of the preventive and corrective maintenance monitoring program.
  • Oversight of the QC compliance process
  • Provide direction to Managers and staff that support the Compliance programs.
  • Ensure that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with procedures and regulatory requirements.
  • Assist Quality Control personnel in meeting timelines associated with investigations, deviations, corrective and preventative actions and change controls.
  • Report Quality Control metrics associated with data generated and quality system to regulatory agencies and Quality Control managers.
  • Provide feedback to Quality Control personnel on trends that have been identified within the quality system and promote continuous improvement in this regard.
  • Develop Compliance Specialists to comprehend quality system inputs and provide support to Quality Control personnel in completing tasks.
  • Oversee Quality Control's coordination of subject matter experts during regulatory inspections.
  • Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.

Education and Experience:

  • BS in chemistry, biology or related field with 8+ years relevant experience (pharmaceutical or biotechnology industry) in laboratory management and analytical sciences and 5+ years' experience in a supervisory/leadership capacity.
  • Thorough understanding of equipment qualification & maintenance activities and Industry Compliance norms.

For more information on this and similar position please contact Kathryn on 01 6455244 or email

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