Candidates login or register below

Like Us

Candidate Login / Register
Sorry, but this job has expired. Please try another search or browse our jobs.

Quality Assurance Manager

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
QA Jobs
Country:
United Kingdom
Region:
Essex
Contract Type:
Permanent
Currency:
£
Salary:
45,000 to 50,000 per annum
Salary Description:
benefits
Posted:
18-Oct-18
Recruiter:
Key People
Job Ref:
23619

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.

Responsibilities:
*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.


Requirements:

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:
*Licensing
*Marketing

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 tbarratt@keypeople.co.uk

Closing Date:
26/10/2018

Return to search.

This website uses cookies. Read our cookie policy for more information. By continuing to browse this site you are agreeing to our use of cookies.

Latest Job Listings