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Senior Quality Manager

Contract Type: Permanent
Location: Louth
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie

Job Description

Senior Quality Manager North Leinster

To maintain the corporate Quality Management System to ensure that all GDP requirements are met and to support QA requirements of Pharmaceutical Development.
  • Co-ordinate the development of new documents related to the corporate Quality Management System
  • Ensure where applicable local sites have in place procedures to address corporate requirements
  • Maintain the Quality Manual
  • Continuously develop and maintain the corporate Quality Management System
  • Prepare material for the senior management review at least twice annually
  • Oversee the Quality KPI program and provide an update in the senior management review
  • Develop and deliver training on the corporate Quality Management System
  • Ensure oversight of third-party suppliers including qualification and on-going monitoring
  • Manage the internal and external audit program
  • Maintain a central repository for Quality and Technical Agreements
  • Ensure consistency with other functional areas in the company in terms of their written procedures
  • Ensure that all Good Distribution Practice (GDP) activities are executed in accordance with procedures, the Wholesale Distribution Authorisation and the GDP regulations
  • To provide the necessary Quality support to Pharmaceutical Development
  • Demonstrate high levels of leadership and people management skills
  • Assist with due diligence as required
  • Undertake any other duties, which may be assigned by Senior Management

Person Spec

Strong preference for an advanced degree, or BSc in Chemistry, Biochemistry or a related science degree with a minimum of 10 years’ experience of pharmaceutical Quality Assurance.

Experience in the following
  • managing a Quality Management System (QMS).
  • developing and managing a corporate QMS.
  • working with third parties including qualification and oversight.
  • Quality support for R&D.
  • preparing documentation for senior management reviews.
  • designing and delivering training.

Specialist Knowledge
  • Excellent knowledge of GMP and good knowledge of GDP.
  • Knowledge of applicable CFR, ICH and EU regulations.
  • Knowledge of software applications such as document management, Quality event management and training.

Special Skills
  • Technical writing skills.
  • Ability to problem solve and take initiative.
  • Good IT skills.
  • Ability to work under pressure.
  • Ability to multi-task and manage several projects simultaneously.

Disposition
  • Proven interpersonal skills.
  • Self-motivated and able to work without close supervision.
  • Excellent attention to detail and organisational skills including ability to prioritise, effective time management and working to timelines.
  • Ability to supervise and motivate personnel.
  • Effective communication skills

Cv to gavin@rftgroup.ie