An opportunity has arisen for a Quality Manager. Due to business growth, we have recently expanded our Regulatory GLP services at the Dundee site.
Our business is focused on several core sectors including pharmaceutical, biotechnology, food, environmental, chemical and consumer products industries.
The successful candidate will be required to further develop and maintain the Quality Assurance Programme for GLP and Good Clinical Practice (GCP) and perform the independent monitoring for compliance with the current regulations. This role is also required to take the lead and train operational staff in the requirements of GLP and GCP.
The QM's function is the independent GLP monitoring of work conducted at the Dundee site as required by the regulatory guidelines employed therein. The QM is responsible for the day to day management of QA. In addition, travel may be required to carry out audits performed at other sites as well as Suppliers and Subcontractors.
To do this the Quality Manager shall:
- Assume responsibility for the maintenance of the QA programme in accordance with current regulations and guidance.
- Assume responsibility for the day to day management of QA functions.
- Perform all aspects of GLP and GCP monitoring of work conducted.
- Review the QA programme to ensure it meets regulatory requirements and is of maximum benefit, reporting any deficiencies to the VP of Quality
- Develop or improve, in conjunction with the VP of Quality and colleagues across other sites, auditing strategies for new systems introduced at Dundee or other sites as required.
- Work with site Management to ensure GLP/GCP standards are maintained.
- Develop in conjunction with the VP of Quality and colleagues across other sites and deliver formal GLP and GCP training.
- Act as QA contact for site.
SUMMARY OF DUTIES AND RESPONSIBILITIES:
- Review Study Plans for compliance with GLP/GCP where required.
- Write and review QA Standard Operating Procedures.
- Review Standard Operating Procedures for compliance with principles of GLP/GCP.
- Schedule, conduct and report audits as required, this will include but not be limited to:
- Study/Analytical phases.
- Standard forms/templates.
- Computer system validation.
- Advise management of any deficiencies in Regulatory Requirements.
- Host or partake in Sponsor and Regulatory visits/inspections.
- Liaise with site personnel to ensure a full understanding of regulatory requirements.
- „Train other personnel in all aspects of Quality Systems and Procedures as required.
- Perform administrative tasks as required.
- Proven knowledge, skills and abilities in managing GLP and GCP systems and Regulatory Requirements.
- Scientific background
- Excellent organisational, interpersonal and communication skills.
- Competent at preparing and delivering presentations to employees, customers and regulatory bodies.
- Strong management skills and ability to lead a team through change.
- Proven ability to challenge and drive quality and a compliant culture forward.
- Experience in influencing, impacting and leading QA operations through developing audit schedules, training initiatives, QA recruitment.
- Ability to investigate and review information and draw conclusions in support of CAPA, deviations etc.
If you are interested or would like more information please contact me.
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