Calling all Senior Clinical QA Auditors!!! I have a contract position 3-6 months, to join one of the world’s most renowned Oncology Trial Specialists. This is an office based contract role in Central London.
Areas of Responsibility:
•To plan, conduct and report on study related audits:
•Investigator’s site audit, laboratory audit, documentation review audit (protocol, clinical study report, investigator’s brochure, case report form, laboratory data report...), TMF audit, database audit
•To plan, conduct and report on internal system audits at DDO
•To plan, conduct and report on external audits related to DDO activities (e.g. service provider audit)
•To be responsible for tracking and closing out audit findings within appropriate timelines
•To demonstrate knowledge and expertise in GCP and GCLP
•To develop and maintain knowledge in GXP
•To liaise and work with GMP and GLP colleagues as required
•To assist in the development of a robust CAPA management process
•To assist in the management of the QAAD database for effective use and help draw up and implementation of enhancements
•Act as a source of advice and guidance on quality/GCP matters to ensure compliance is achieved
•Identify issues that have bearing on management of DDO clinical trials and make recommendations to the QA manager.
•To work with colleagues at DDO to develop and improve standard practices and collaborate efficiently to ensure the implementation of quality standards from early planning of clinical trials through the conduct and reporting of clinical trials
•To review and update SOPs as required under the Quality Management System
•To assist the QA Manager in the preparation, update and implementation of the function audit programme
•To assist the QA manager in hosting regulatory inspections and audits from third parties
•To assist the training manager in delivering training to DDO staff when required
•Representing where appropriate at conferences/meetings or on external bodies
•Assist the manager in achieving the functional area goals (e.g. audit programme, regulatory inspection, audits from third party)
•Work with colleagues at DDO to develop and improve standard practices and collaborate efficiently to ensure the implementation of quality standards from early planning of clinical trials through the conduct and reporting of clinical trials.
•Liaise with GMP and GLP colleagues as required.
•Facilitate and drive process improvements related to the role including generation and ownership of Controlled Documents (SOPs and Guidance Documents).
•Act as a source of advice and guidance on quality/GCP matters to ensure compliance is achieved
•Identify issues that have bearing on management of DDO clinical trials and make recommendations to the QA manager.
•Excellent knowledge of GCP and GCLP and able to apply to functional area. Will to develop and maintain knowledge in GLP and GMP
•To assist in the management of the QAAD database for effective use and help draw up and implementation of enhancements
•Representing the company, where appropriate at conferences/meetings or on external bodies e.g. ECMC working groups, ICR, BARQA
Essentials:
•Excellent knowledge of ICH GCP content, history and application
•Excellent knowledge of the EU clinical trials regulatory documents which affect clinical trials in the UK
•Good knowledge of GMP and GLP One year minimum of laboratory experience.
•Requirement to be flexible, innovative, to be able to influence and negotiate on QA issues, to be willing to share knowledge and build working relationships.
•Science degree or equivalent
•Minimum 3 years experience of working in a QA / GCP environment within clinical trials
•Experience of conducting or organising audits
•Experience of working in Pharmaceutical/Biotech Industry
•Experience of regulatory inspections.
If you fit the above job description please contact Sue Spice at Datatech on 01256 314 640 or email us on [log in to unmask] Alternatively, Refer a Friend or Colleague.
Take part in our fantastic referral scheme! If you have a friend or colleague who would be interested in this role, please refer them to us. For each relevant candidate that you introduce to us (there is no limit) and we place, you will be entitled to our generous gift / voucher scheme.
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