QA Manager

Key People


Job ID :

12986


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Essex,Stansted,


Key Skills :

Quality Assurance, QA, quality, GMP, GDP, Essex, pharmaceutical, distribution, manufacturing


Salary :

£30 - £40 per hour


Date Posted :

19 Sep, 2018



Company Name :

Key People


Location1 :

Stansted




Job Category :

Data Management 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 an initial 6 month contract 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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