QA Manager

Key People


Job ID :

12987


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Braintree,Braintree,


Key Skills :

QA, quality, quality assurance, compliance, essex, quality manager, pharmaceutical


Salary :

£45000 - £50000 per annum + benefits


Date Posted :

19 Sep, 2018



Company Name :

Key People


Location1 :

Braintree




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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