Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Senior Quality Assurance Auditor (Early Clinical Development - Phase 1 EMEA) Home or Office based Salary: Negotiable/dependent on experience An exciting opportunity to join a Globally recognised CRO who are offering market leading development of audit skills
Senior Quality Assurance Auditor (Early Clinical Development - Phase 1 EMEA)
Location: Home or Office based
Salary: Negotiable/dependent on experience
An exciting opportunity to join a Globally recognised CRO who are offering market leading development of audit skills and reports which will be efficiently used to assess regulations, compliance and guidelines to help support the management and demonstrate consultation for these aspects.
Responsibilities (to include, but not limited to):
*Design, schedule, construct, report and complete audit activities in any of the countries associated with the companies contracts. Audits are constructed to test compliance with applicable regulations/guidelines, customer necessities, SOPs and project specific guidelines/instructions
*Give consultation to customers and monitors in clarification of audit observations and formulation of remedial action plans.
*Assess audit results and organise and allocate reports to customers, management and operations staff
*Deliver interpretation and consultation to project teams on regulations, compliance status, guidelines, policies and procedures.
*Support in holding mock regulatory inspections and regulatory facility inspections by acting as scribe and/or assessing documents and classifying and contacting operational staff to answer questions as appropriate.
*Appraise policies and procedures for compliance with appropriate regulations/guidelines and deliver recommendations to management for ongoing process improvements.
*Undertake quality assurance consultancy activities and projects for clients within projected timelines and budgets.
*Support in training of new Quality Assurance staff.
*5 year experience in pharmaceutical, technical or related area, of which ideally 3 years in Quality Assurance; GXP experience, preferably Early Clinical Development; or equivalent blend of training, experience and education.
*Excessive knowledge of pharmaceutical research and development processes and regulatory environments, predominantly knowledge of Early Clinical Development,
*Experience in quality assurance process and procedures
*Travel necessary, including international travel.
*Ability to undertake assigned tasks and to work independently
*Managing multiple projects
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion.
Key Words: GXP, GCP, Audit, Auditor, R&D, QA, Quality Assurance, CRO, SOP, Audits, Early Clinical Development
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