- Responsible for Tower Mains’ Central European operation in the Slovak Republic.- Planning, conducting, and reporting compliance audits.- Regulatory and GCP subject matter expert.

Additional to the duties outlined for the below role:- Scheduling and co-ordination of TMQA’s clinical audit programme.- Supervision of delivery of TMQA’s clinical audit programme. - Training and supervision of allocated staff.

- Ensuring best practice in audits such as generating audit checklists, templates, and guidance documents.- Specialist client relationship manager: providing professional advice on regulatory and GCP matters.- Conducting or organising staff training on regulatory information.- Reviewing audit reports.- Mentoring TMQA colleagues.

As a clinical auditor at a major pharmaceutical company, main duties were:- Independent planning, conduct and reporting on compliance audits with focus on clinical site audits (phase I – III) and GCP/Good Manufacturing Practice (GMP) compliance. Reviewing audit responses/Corrective and Preventive Actions (CAPAs) for acceptability and conducting follow up. Escalating significant compliance issues per company procedures/quality standards.- Providing QA support for compounds in clinical development, including, but not limited to: audit planning, review of audit reports for consistency prior to report issuance, timely provision of audit metrics/aggregate audit information to the clinical development teams and QA management, participation in quality management meetings, interaction with the functional personnel regarding compliance-related enquiries and appropriate management and escalation of issues through to acceptable resolution.- Assisting in the preparation for and conduct of regulatory authority inspections.- Supporting special projects related to QA functional issues and beyond; interacted with other departments on quality-related topics to influence strategy and nurture the culture of continuous process improvement.- ‘Change champion’ for the QA department.- Participating in procedural document updates and process gap analyses/improvement initiatives; championed standardisation.- Part of the support team for the QA audit database which included technical troubleshooting and training of staff.

As the Manager of the QA department of a Phase I Unit - Contract Research Organisation, main duties were:- Independent planning, conduct and reporting on audits of early phase clinical trials and the associated company systems and processes to ensure compliance with applicable GCP/GMP regulations and guidelines and company/sponsor Standard Operating Procedures (SOPs).- Performing qualifying and compliance audits of external service providers.- Quality control of key GMP processes.- Maintaining the company’s Quality Management System; shaping the company’s processes and procedures, utilising appropriate quality management principles.- Maintenance of CAPA plans resulting from internal and external audits/inspections, incident/near-miss investigations and quality improvement initiatives; keeping senior management apprised of any systemic/significant issues.- Coordinating compliance audits/inspections by regulatory authorities and sponsors’ representatives.- Line-managing one direct report.- Providing guidance and training to staff on GCP, GMP, SOPs and inspection readiness and participation in Business Development activities.

Duties:- Coordinated and motivated a team of four Radiation Protection Supervisors; became Head of the team in Sep 2007.- Performed feasibility and risk assessments of clinical trials involving work with ionising radiation.- Ensured that the processes in place, as defined in the Local Rules, Ionising Radiation Safety Policy and SOPs, were in line with the applicable regulations; ensured procedural and policy documentation was current and accurate.- Supervised and trained staff working on radiation studies to ensure safe working practices; developed staff training programmes.

Duties:- Provision of a Phase I and II Clinical Trial Supplies service; Pharmacy Technician and Production Manager since 2005.- Established processes and procedures of the Pharmacy department; ensured compliance with GMP, GCP, the UK Medicines Act and other applicable guidelines and regulations. Ensured company ISO 9001 certification requirements were met.- Coordinated, trained and motivated a team of four staff to ensure day to day activities of the department were in compliance with corporate policies, client specifications and Unit SOPs; formed, supported and influenced internal/external relationships.- Health and Safety Representative for the Pharmacy department.- Wrote new and updated existing SOPs; business unit specialist in using a company SOP database.

Duties:- Compounded parenteral nutrition, aseptic dispensing, aseptic manufacture of intravenous batches, provided Centralised Intravenous Additive Services and Oncology Services and was responsible for stock maintenance of medicines on wards; trained new and rotational staff.