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Senior Quality Manager

Job Title: Senior Quality Manager
Contract Type: Permanent
Location: Louth
Industry:
REF: 123706
Contact Name: Gavin Kennedy
Contact Email: gavin@rftgroup.ie
Job Published: about 1 year ago

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