Development Quality Associate (GCP) - long Contract

We are currently recruiting a CONTRACT Development Quality Associate (GCP) for our large global pharma client. This client is recognised worldwide for the innovative medicines they provide to patients and healthcare professionals, developing and marketing patent-protected prescription only medicines for important health needs.

This position will be responsible for GxP oversight and for assuming the quality and compliance of Development and Medical Affairs projects, products and programs from phase 1 through to phase IV. The successful incumbent will ensure, in direct collaboration with the Country Pharma Medical Department, the implementation of the Quality Manual and Quality Management System in the Medical Department to achieve a high level of quality and compliance.

This position is offered on a one years' contract basis, either as a Fixed Term Contract or on a Limited Company contract day rate basis. A contract extension beyond the initial one year could be a strong possibility.

The accountabilities of the role are as follows:

* Implement and maintain the local Quality System in the areas of GxP, in accordance with the Quality Manual and Country Pharma Quality plan
* In cooperation with the local Drug Regulatory Agency and Drug Safety and Epidemiology, keep abreast of regulatory requirements, and up-date local management and pharma development Medical Affairs/Country Pharma QA on the possible ramifications of regulatory changes and impact to Clinical Development, Medical Affairs and GxP processes
* Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators and assure that gaps are addressed appropriately in order to mitigate risk
* Conduct vendor assessment and/or qualification visits for locally outsourced clinical development, Medical Affairs and GxP activities
* Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical findings
* In cooperation with the local GMP associates ensure analysis, assessment and resolution (including corrective and preventative actions where indicated) of issues with common interfaces.
* Participate in Pharma Development QA investigation activities, as appropriate
* Ensure, where appropriate, interface/communication with authorities for any GxP related activity (eg local Health Authority (HA) inspections)
* Provide support prior to, during and after HA inspections of the Country Pharma Organisation, investigational sites or external service providers, as applicable, together with the inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant corrective actions have been completed/closed
* Ensure conduct of adequate training at the Country Pharma Organisation for all GxP activities by defining, planning and supporting regulatory training activities
* Ensure that the GxP computerised systems are adequately identified during the High level Classification Document for GxP relevance to enable their validation where required
* Conduct other QA related activities in line with the Global Quality plan as defined by the Development QA Manager or CPO Quality Unit Head

Experience/qualifications

* Degree in life sciences or related fields, or equivalent experience
* GCP experience is essential
* Experience in clinical QA is preferred
* Prior experience of working in a pharmaceutical or CRO environment is essential

Hy-phen Limited is acting as an Employment Business in relation to this vacancy.

The Adecco Group UK & Ireland is an Equal Opportunities Employer.