Quality Supervisor - Validation

Science & Pharmaceutical
Science & Pharmaceutical
Dublin
Fixed Term Contract
16950
Dublin
Fixed Term Contract
16950

My client, a multinational pharma company based in Dublin is looking to hire an experienced QA Supervisor. They ideally will have 3+ years’ experience in a similar role, have experience in Quality Assurance, Validation and must have strong people management experience.

This role is a 12-month fixed term contract.

Responsibilities:

  • Provide Support and guidance for the Quality Validation Team. 
  • Work with Planning, Production, QA Production Support, QA Systems, QC, QP, and Materials Management to
  • establish priorities; communicate issues and resolve issues; and communicate progress.
  • Cross train QA Validation team on the various processes. 
  • Supervise key site quality systems such as Change Control, Deviations, CAPAs, Product Quality Reviews,
  • Internal Auditing, Regulatory audits, Corporate audits, Site Quality Reviews, Document Management and Control, Technical Agreements and Site Master File. 
  • Measure, report and trends site performance on key indicators of these quality systems through metrics. 
  • Ensure quality system performance is appropriately and well communicated throughout site. Provide guidance
  • and assessments to the site Quality Validation Team. 
  • Ensure site compliance with Irish Medicines Board, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate.
  • Supervise and direct all deviation investigations.
  • Develop a support/service mentality in Quality staff, partnering with local site departments.
  • Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines. 
  • Seek process innovation and continuous process improvement in QA function.
  • Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. 
  • Allocate and coordinate personnel resources to all QA compliance activities and provide direction to ensure that
  • specified targets for team are met.
  • Maintain accountability for own team’s performance metrics that support the annual operating plan and site strategic plan objectives.
  • Ensure data reports on own team’s performance are current, accurate, and distributed according to defined procedures. 
  • Contribute to the continual improvement of QA documentation and ensure that they are current, accurate, and clearly define process and role responsibilities.
  • Provide hands on training, support, and coaching to reports.
  • Enforce cGMP, safety, housekeeping, and security procedures, maintaining a safe working environment and promptly reporting incidents and accidents to site leadership.
  • Complete and conform to all training requirements for job role, including company-required and job role-specific training. 

Requirements:

  • Must have a relevant third level bachelor’s degree in Chemistry or related Science discipline
  • Must have 3-5 years’ experience in a similar role working with pharmaceutical processing technologies with
  • preferably some of this experience in Quality Assurance. Good understanding of 21CFR / cGMP documentation and electronic systems requirements.
  • Must have strong people management experience in aligning individuals and teams to business objectives
  • Must have exposure to Lean manufacturing concepts and experience in managing by metrics

What’s in it for you?

  • Competitive package
  • Pension
  • Healthcare
  • Life assurance
  • Excellent company culture
  • Excellent opportunity to develop experience and career in a multinational pharma company

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For a confidential discussion and more information on the role, please contact Niamh Cregg

naimh.cregg@collinsmcnicholas.ie

0719149732

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Your Consultant
Niamh Cregg
Senior Recruitment Consultant