Reference Number: JO-2006-450942
QA Officer and Deputy NPPV
Job Type: Permanent
Quality Assurance Officer, GPV.QMS specialism
Salary details available on discussion + excellent benefits package
My client is an exciting global immunotherapy specialist primarily focussed on the R&D and production of allergy therapies based in Berkshire who are currently seeking a Quality Assurance Officer to join their business on a permanent working basis. The position will offer you the opportunity to develop your skills and experiences within Quality Assurance with a particular focus on Pharmacovigilance practices.
If you are looking for the opportunity to develop yourself, then this could be just the role for you. With excellent training and development opportunities and the chance to be part of the global QA team, now really is the time to get in contact to explore further.
You will support the maintenance of the UK quality system, maintaining an internal SOP system, ensuring all company staff are trained and up to date with the relevant SOPs and responsibilities. You will also advise colleagues on areas for improvement within departmental and project specific processes and facilitate the necessary changes.
Other key responsibilities will include:
Work with global QA and UK Responsible Person to ensure that the robust quality system is in place and adheres to GXP practices including Change Controls and Deviations.
Manage quality issues between all involved parties such as product management, regulatory affairs, global quality unit and customers.
Act as back up contact for the European QPPV including communication with competent authorities, healthcare professionals and consumers with respect to all safety issues.
Support audits of internal and external vendors.
Assist with the delivery of the companies audit program.
Successful applicants must be able to demonstrate Quality Assurance experience as well as strong understanding of pharmaceutical quality management systems ideally within a clinical trial/clinical operations/drug safety environment as well as experience of both developing SOP procedures, and if possible experience to include hosting and conducting audits.
You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of quality pharmaceutical procedures.
Ideally a knowledge, interest or understanding and application of QMS and PV guidelines and regulations.
Fluent English communications skills (written & spoken).
Ability to work independently.
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 207 822 1710 or send an updated version of your CV via email to email@example.com
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.