Quality Assurance Officer-GMP-QMS-Audits-Perm-Surrey-£24k-£28k

Location
Surrey, England
Salary
GBP24000.00 - GBP28000.00 per annum
Posted
Sep 23, 2016
Closes
Oct 21, 2016
Ref
BBBH4408
Contact
Kristian Sparrow
Result Type
Jobs
Position Type
Permanent
Hours
Full Time

Quality Assurance Officer-GMP-QMS-Audits-Perm-Surrey-£24k-£28k

A leading manufacturer of unlicensed medicines requires support within its Quality team responsible for Quality Assurance Compliance (GMP, GDP, GCP). You will be supporting the Daily administration, maintenance and development of the Quality Management System Documentation, in cooperation with the Head of Quality to provide QA knowledge and support to assure compliance whist meeting the changing business needs.

You will be educated to degree standard in a relevant subject and have a minimum of 3+ years' experience gained preferably from within Pharmaceutical Manufacturing or associated industry.

Job Responsibilities:

*In liaison with the Quality Manager help provide assurance that company systems remain in compliance with cGMP/GDP/GCP requirements at all times.
*Responsible for the day to day management and control of IMP documentation
*Maintenance of the QMS for compliance and to improve quality, efficiency and productivity.
*To facilitate the continuous improvement of quality, efficiency and productivity within the business
*In liaison with Quality Manager and Procurement help maintain and control the supplier and raw material approval process
*In liaison with the Quality Manager facilitate the timely investigation of complaints
*Provide expertise and advice to facilitate the timely documentation and closure of assessments and investigations arising from quality events in compliance with ICH Quality guidelines.
*To report weekly on the performance of the QMS and trend against KPI to the Head of Quality and senior management.
*To pro-actively assist departmental mangers and representatives as appropriate in the generation, review and approval of procedures and associated QMS controlled documentation used in the manufacture and distribution of unlicensed medicine.
* To pro-actively assist departmental mangers and representatives in the generation, review and approval of procedures and associated QMS controlled documentation used in the manufacture and distribution of Investigational Medicinal.
*Within the limits of responsibility assure that all areas, sites, stores and records which relate to the licensable activities are appropriately maintained.
*To attend Quality Review meetings and other management meetings as required.
*Subject to experience, to perform in GMDP audits and participate in Regulatory Inspections as required.

Essential Requirements:

*A minimum of 3+ years Quality Assurance Experience gained preferably from within Pharmaceutical Manufacturing or associated industry.
*Credible and confident communicator (written & verbal) at all levels, with excellent presentation and problem solving skills essential.
*Good working knowledge and understanding of current GMP / GDP / GCP.
*Good attention to detail and the ability to work efficiently either as part of a team or alone in a fast paced changing environment.
*A motivated team player with their own inventiveness and good problem solving skills
*Good time management and a flexible attitude are essential to this role.
*Good knowledge of Microsoft Office software.
*Experience of participating in or completing quality audits an advantage
*Ability to achieve and maintain high standards with meticulous attention to detail unsupervised.

Quality Assurance Officer-GMP-QMS-Audits-Perm-Surrey-£24k-£28k