Quality Assurance Manager

Key People

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Job ID :

12945


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Essex,Essex,


Key Skills :

quality, quality assurance, consultant, pharmacovigilance, drug safety, generics, GMP, GDP


Salary :

£35000 - £60000 per annum + benefits


Date Posted :

14 Sep, 2018



Company Name :

Key People


Location1 :

Essex




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

I am currently searching for a Quality Assurance Systems Manager to join a growing Pharmaceutical company based in Essex. Within this role you will be responsible for implementing and maintaining the company Pharmaceutical Quality System including the Documentation Control System, Deviation, Complaint and CAPA Management.

Responsibilities:

*To report to Head of Quality and work alongside the Quality Compliance Manager, Senior Business Development Manager, Regulatory Affairs, NPI Manager and MD.
*Ensure that the Pharmaceutical Quality System enables the client to fulfill the requisite responsibilities of an MA Holder
*Preparing, implementing and maintaining the quality systems required to support in addition to Documentation Control System, Deviation, Complaint and CAPA Management, Training and Standard Operating Procedures - Supplier Qualification, Quality Agreements, Technical Agreements and Safety Data Exchange Agreements as Complaints/ADR recording, reconciliation and the internal/external audit program
*To be named and undertake the responsibilities and duties of the Responsible Person as defined within EU Current Good Distribution Practice
*To take responsibility, review and approve the Quality Management System for the client including Quality Manual, Change Control, Deviation Management, CAPA, Quality Risk Management and the Quality System Review
*Manage and develop the Complaint Management System including Recalls and Falsified Medicines
*Manage and develop, review and revision of Standard Operating Procedures with assistance from the Head of Quality
*Assist in the training and implementation of QA procedures for GMP compliance
*Act as primary company contact for Third Party Logistics providers, including the management of the Quality Review process and the preparation, analysis and response to key performance indicators
*Participating in Continuous improvement activities.
*Possible involvement with PV and Medical Information reconciliation, liaising with Business Development Manager and Department, Regulatory Affairs and MD; communicating information and updates as appropriate
*Liaising with the Regulatory department when necessary with regards to review and preparation of SDEAs.

Specialist Knowledge:


* Quality Assurance
* Compliance Management
* Auditing
* Pharmaceutical Operating Procedures
* MHRA
* Validation

For further details about this role or other vacancies within Quality Assurance, please contact Tim Barratt on 01727 817 626 or email 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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