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Senior Quality Manager

Location Dublin North, Dublin
Sector
Job Type Permanent
Salary Negotiable
Published 2 months ago
Start Date February 2019
Contact Lorraine Mooney
Job Ref NJ0001_1547040584

Job Description

Senior Quality Manager | Pharmaceutical | Dublin North

My client is seeking a Senior Quality Manager with exceptional experience in the Pharmaceutical Industry at Senior Level. This role will be part of the Senior Management Team with 5 direct reports. The main purpose of this role is to be responsible for all site quality metrics and activity and to work in conjunction with the QP Team to ensure all matters relating to batch release are managed and addressed.

Main Duties:

  • Take an active role in the site QMS by reviewing and approving investigations, procedures and CAPAs
  • Attendance and input to site Quality Management Review Meetings
  • Take an active role in developing site QMS to be compliant with new Regulations
  • Ensure that all operational Quality issues are working well and that improvement projects are in place to address any gaps found
  • Ensuring the generation of and performing review of site PQRs
  • To represent the Quality Department in all site scheduling meetings, and to provide decisions and guidance on the available service levels for QP certification
  • To attend customer meetings where quality support is needed
  • To provide Quality expertise for NEW product Introduction, liaising with site Project Managers and the customer.
  • To manage the current team of Quality personnel involved in the Operational Quality

Requirements:

  • Degree level or above in a Scientific discipline
  • Eligible to act as a Qualified Person under directive 2001/83/EC
  • Knowledgeable of current EU Regulations and upcoming changes
  • Extensive experience in the Pharmaceutical Industry at a Senior level
  • Experience of hosting Regulatory Inspections and client audits
  • People Management Skills

In Return:

  • Excellent Package
  • Career Progression

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