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Quality Assurance Manager

Job Field:
Regulatory and Drug Safety Jobs
QA Jobs
United Kingdom
Contract Type:
45,000 to 50,000 per annum
Salary Description:
Key People
Job Ref:

My client, an Essex based Pharmaceutical company, are currently searching for an experienced QA & Compliance Manager to join their team on a basis. Within this role, you will provide support to the GMP and GDP contract providers as well as ensure that marketed products meet the registration, GxP and regulatory authority requirements.

*In their absence, deputise for the Quality and Compliance Director
*Ensure the effective maintenance of the QMS is maintained based on change and risk management principles, across the product lifecycle including pharmaceutical development, technology transfer, commercial manufacture and distribution, post-marketing and product discontinuation
*Provide support to the GMP and GDP contract providers in all Quality matters and to provide operational direction to the provider.
*Ensure QTAs are in place with the service providers and appropriate oversight of the service providers including audit.
*Ensure availability of appropriate resource to ensure all Quality responsibilities can be fulfilled.
*Reviewing and approving the Quality manual, Global Policies and any policy/instruction exemption request
*Ensuring timely and effective communication, escalation and action for product quality and QMS failure
*Ensure effective partnership with other areas in the Company including Supply Chain, Regulatory Affairs and IT.
*Ensure marketed products meet registration, GxP and Regulatory Authority requirements.
*Ensure Quality objectives and performance indicators are in place, monitored and appropriate actions taken as required.


It's essential that you have the following experience:
*Excellent GDP and GMP knowledge
*Experience of Quality Systems appropriate for Commercial Drug Product
*Experience of Distribution Supply Chain Operations and Vendor Assessments
*Knowledge of PV and Medical Informations system
*Knowledge of applicable ICH, EU an GxP regulations

Desirable experience includes:
*Undergraduaate Life Science Qualification
*Diploma in Pharmacovigilance/Certificate in Pharmacoepidemiology and Pharmacovigilance
Proven experience in regulatory affairs:

For further details about this role, or other opportunities within Quality Assurance, please contact me as soon as possible on +44(0)1727 817 626 or send a copy of your CV to

Closing Date:

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