Product Quality - Senior Manager

Competitive
Permanent
Cork
17 Oct 2019
BBBH744465

Highly enticing Product Quality Manager position located South of the Tunnel

PURPOSE OF JOB:

The post holder will be responsible to manage and develop a team of product quality specialists and a QC team headed by a laboratory manager. Be a source of technical guidance to support the team's activities. Provide assurance that product from multiple global contract manufacturer sites are manufactured and tested in compliance with CGMPs, US FDA, Canada and other applicable regulations. Ensure that product complaints are investigated appropriately and closed in a timely manner.

KEY RESPONSIBILITIES:

Laboratory:

  • Oversee a testing laboratory in accordance with best compliance practise
  • Ensure a high degree budgetary oversight for laboratory operations
  • Ensure smooth operation of system for sampling, shipment, testing, control of product quarantine/release for all the business' US products

Batch Acceptance:

  • Ensure all records related to batches and shipments for the business and its sister label products are reviewed, accepted/reject and maintained
  • Ensure adequate oversight and review of Deviations, Investigation reports and the assessment of assigned CAPA's and timely follows up with contract manufacturers as needed to ensure effective resolution
  • Ensure Review of Process validation and annual product reviews of products at contract manufacturers to ensure products are validated and remain validated
  • Ensure appropriate technical documents are available, tracked and critically assessed, as appropriate, to support distribution of their own labelled product e.g. stability studies, analytical and process documentation
  • Oversight of systems for trending critical analytical data and stability data as appropriate for all products.
  • Provide oversight of temperature studies from transport activities, identify issues and follow up as appropriate

General:

  • Ensure that product complaints are investigated appropriately and closed in a timely manner
  • Ensure system is in place for risk assessment and escalation of complaints to senior management and suppliers
  • Liaise and build relationships with manufacturers and involved parties to ensure product quality issues are investigated in a timely manner and are documented appropriately
  • Ensure contact manufactures maintain compliance with quality agreement
  • Provide quality leadership, direction and support to quality staff and manufacturers.
  • Liaise with the Supplier Quality Group, to focus on key quality areas of outsourced activities during supplier audit and technical visits
  • Keep Quality Management and team updated on issues which impact the business
  • Liaise with internal and external customers, provide data and assistance to ensure activities run smoothly
  • Empower develop and oversee team
  • Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required and cross training as required

REQUIREMENTS:

Education/Training:

Educated to degree level or higher, ideally B.Sc. or post graduate studies in Chemistry, Microbiology, Chemical Engineering; other related scientific disciplines may be considered.

Experience:

7+ years' experience, may be less where person holds a higher degree, including 2 years managerial in finished dose pharmaceutical manufacturing; preferably in a progressive multinational organization. The post holder will have technical manufacturing, quality or laboratory experience.

Knowledge and Skills:

  • Solid understanding and knowledge of cGMP and the regulatory framework for the manufacture and supply of finished dose pharmaceutical products
  • Thorough knowledge of pharmaceutical testing and batch release processes
  • Sound technical knowledge of multiple dosage forms
  • Proven record in analytical decision making on complex analytical issues
  • Strong soft skills with ability to communicate at all levels within the organization and drive results
  • Ability to transfer findings into report and presentation formats
  • Ability to work effectively with others inside and outside their team to accomplish goals in a timely manner
  • Demonstrated ability to lead and develop others to improve performance or effectiveness

Work Environment/Physical Demands:

  • General office environment; however foreign travel will be required from time to time to meet business needs.

Morgan McKinley is acting as an Employment Agency in relation to this vacancy.

Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.

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