Katarina Eghan, MSc
Director, TMQA Central Europe/Principal Associate, Tower Mains Ltd. at Tower Mains- Claim this Profile
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Slovak -
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English -
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Czech -
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Experience
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Tower Mains
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United Kingdom
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Research Services
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1 - 100 Employee
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Director, TMQA Central Europe/Principal Associate, Tower Mains Ltd.
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Jan 2014 - Present
- Responsible for Tower Mains’ Central European operation in the Slovak Republic.- Planning, conducting, and reporting compliance audits.- Regulatory and GCP subject matter expert.
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Head of Clinical QA Services
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May 2018 - May 2019
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.
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Principal Associate
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Nov 2013 - May 2018
- 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.
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QA Specialist
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Nov 2010 - Nov 2013
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. Show less
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Richmond Pharmacology
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United Kingdom
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Research Services
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100 - 200 Employee
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QA Manager
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Aug 2008 - Nov 2010
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. Show less
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Quintiles
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Spain
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Radiation Protection Supervisor
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Jun 2005 - Aug 2008
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. Show less
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Pharmacy Technician - Production Manager
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Jan 2005 - Aug 2008
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. Show less
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St Georges Healthcare NHS Trust
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United Kingdom
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Mental Health Care
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700 & Above Employee
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Assistant Technical Officer - Senior Assistant Technical Officer
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Nov 2002 - Jan 2005
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. 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.
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Education
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Cranfield University
Master of Science (MSc), Quality Management in Scientific Research and Development -
The Open University
BSc (Hons), Mathematics and Statistics -
Gymnazium Banska Stiavnica
A-level equivalent