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Vacancy Details


106281 - Quality Manager - Westmeath

Contract Type: Permanent
Location: Westmeath
Date: 19/11/2019
Job Reference: 106281
Contact Name: Orla Crowley
Contact Email:

Job Description

Quality Manager - Westmeath - 106281
Quality Manager

Our client, a medical device company in ATHLONE are currently looking to recruit a Quality Manager for their growing site.

Summary of the Quality Manager
The Quality Assurance Manager will hold responsibility for all QA/QP activities in support of the process through to product release. The role will provide support to the Director of Quality and Regulatory Affairs in achieving the required goals and objectives; meeting customer requirements and the necessary regulatory requirements as lay down by the FDA and EU regulations.

The QM/QP will develop and maintain a clear compliant quality strategy which will ensure cost-effective and smooth quality and product release processes to include the following responsibilities:
  • The Quality Manager is responsible for overall development, implementation, and maintenance of the organisation’s Quality Management System.
  • Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation
  • In collaboration with the Management Team, drive continuous improvement and best practices in our client’s/vendor quality systems
  • Manage all quality system and quality control activities within the quality team
  • Act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex Volume 4 and Directive 2001/83/EC to support disposition of Products
  • Perform final release of the pharmaceutical product
  • Manages the batch disposition process to ensure timely release of products
  • Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements
  • Independently initiate and approve SOP updates and creation of new SOPs. Additionally, oversee review of SOPs and associated documentation to ensure review requirements are met
  • Conduct supplier audits and contractor audits
  • Facilitating, approving and providing inputs into change controls, investigations and non-conformance reviews as required
  • Provide Quality support to site projects
  • Evaluation of CMO’s Quality Management Systems to ensure the appropriate level and content of reporting, including technical evaluation of quality system reports
  • Maintaining and improving quality metrics that incorporate continuous improvement methodologies
  • Ability to independently represent the quality function at project meetings and make sound decisions in support of project needs ensuring quality needs are understood and implemented

The Ideal Candidate:
  • An MSc in Pharmaceutical Science or similar course recognised by HPRA to permit Qualified Person status as per Article 49 of Directive 2001/83/EC
  • At least 5 years’ experience in the Pharma industry within the quality function
  • Experience of working within a FDA and EMA regulated environment
  • Excellent People Management Skills
  • Excellent Organisation, Report Writing, Communication, Problem Solving and Presentation Skills.
  • Sound Decision Making and Negotiation capabilities.
  • Proven to be self-directed, self-motivated and ability to prioritise competing priorities
  • Relationship Building: Establishing excellent working relationships within the qualify team and with all functions within the business.
  • Excellent communication and presentations skills, both written and oral. Articulate the quality requirements in a clear, concise and persuasive manner.
  • Identify and understand issues, problems and opportunities whilst providing a viable solution.
  • Able to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.

For further information on this Quality Manager role in Athlone please contact Orla Crowley on 0860449473/
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