Job Description
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