Qualified Person (QP) - Senior Quality Specialist

Placed: 09/12/17
Region: Oxfordshire
Location: Oxford
Category: Jobs


Content of the advertisement:

We have an exciting opportunity to strengthen our Quality Assurance Department and we are looking to fill the full time position of QP - Senior Quality Specialist at Windrush Court, Oxford.

**About the role**

Qualified Person and Senior Quality Specialist performing batch certification and helping to direct organisational and operational Quality activities.

**Area of Accountability**

**Business Impact**

* Responsible for certifying that Investigative Medicinal Products (IMPs) and or commercial API are manufactured in accordance with GMP
* Member of Quality Leadership / Steering Team
* Input on quality policy, objectives and deliverables for business.
* Input on quality decisions and go-forward strategy, balancing quality with business objectives
* Influence key organisational stakeholders as required.
* Participation at project meetings, client / partner meetings
* Be a key point of contact for external parties for quality.
* Serving as EU Qualified Person (QP) for batch certifications in accordance with 2001/83/EC, 2001/20/EC and SI2012-1916
* Overseeing BMR and supporting record review and approval (deviations, EM, analytical, OOS/OOT etc)
* Providing guidance and integration of European and USA regulations
* Ensuring GMP knowledge of self and others within both the Quality team and other function are kept up to date.

**Innovation**

* Participate in outside organisation technical groups and special interest groups to maintain current knowledge and influence upcoming legislation.
* Maintain CPD in conformance with joint professional bodies expectations and contributes to the sites training program (as required).
* Proactively initiate and lead quality management systems continuous improvement.

**Leadership & Teamwork**

* Senior Quality leader and specialist within the business for Change / Problem Facilitator / Technical Solutions / Innovations / SME.
* Advise quality and other functions (as required) regarding root cause analysis, problem solving, error prevention activities, process mapping / optimisation, system and procedure simplification, human performance / behaviour, process improvements, QRM application.
* Own and lead specific quality owned projects or initiatives.
* Assist validation, engineering, QC, micro, aseptic team, quality improvement team with issues and or improvement programme.

**Communication & Influence**

* Champion a top down quality culture within the business.
* Member of Quality Review meeting / KPIs
* Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16)
* Drive continuous improvement within the QMS
* Participate as required in self-inspection activities and external audits
* Host and support regulatory inspections, audits by clients / partners.
* Manage, mentor, motivate other team members
* Aid in the development, deployment and monitoring of associated resources to meet business needs and department capacity.

**Required Education & Knowledge**

* Must meet eligibility requirements combined with relevant biologics and steriles knowledge to be named on Manufacturers Authorisation for IMPs (or commercial API) from MHRA
* Detailed knowledge of Guide to Good Manufacturing Practice
* Expert knowledge of Validation and Quality Management systems
* Working knowledge of Clinical Trials and IMP Regulatory system
* Life Science degree and or post graduate
* Meets requirements of continuing professional development required to maintain QP status
* Meets requirements of the Qualified Person as detailed in articles 49 and 50 of Directive 2001/83/EU and Medicines for Human Use (Clinical Trials) Regulation 2004
* Extensive knowledge, interpretation and application of quality management within a GxP environment for early phase clinical trials

**How to Apply**

Please use the questionnaire to highlight how you meet the competencies for the role and to state your salary requirements and current salary. Your questionnaire responses will be used along with your CV to assess your application.

**Closing Date 7th January 2018**

Please note that speculative CVs will not be considered.

**Please note that we may when necessary be required to close a job prior to the closing date, due to a large number of applications or change in circumstance.

* The post will close on the closing date stated at midnight *

It is company policy that travel expenses will not be reimbursed. **

Price / Salary: Competitive