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Quality Laboratory Team Manager




Ref:
NESUK-55776
Created Date:
09-02-2010 05:28:59
Job Category:
Country:
United Kingdom
City:
Greater Manchester
Yearly Job Salary:
0


Job Description

 Our client is a world leading manufacturer of medical device and pharmaceutical products and services for the professional health care sector.

We are currently recruiting for a Laboratory Team Manager to join their Quality team.

In this challenging role, you will report directly to the Quality Manager. The purpose of the Laboratory Team Manager role is to ensure the workload of the laboratory is carried out in an effective and efficient manner. This workload includes the testing and release of raw materials, and the subsequent testing and release of finished products. The laboratory Team Manager needs to ensure that GLP is practised throughout the laboratory. The CAPA coordinator aspect of the role is to ensure that the CAPA (Corrective Action / Preventative Action) and Deviation systems are working effectively.

Your main responsibilities will include:
-Supervision of Laboratory personnel. Planning and organising work load, to ensure an accurate and efficient service is provided.
-Responsible for Goods Inward Inspection and subsequent testing and release
-Responsible for Finished product Inspection (including Pharmaceuticals), review of batch records and the subsequent testing and release, including the trending of results.
-Assisting in product trials and developments
-Perform internal and external quality audits.
-Validation of all laboratory equipment and test methods and involvement with other validation activities on site (Process, Product, Software)
-Facilitate the Stability testing of all on-site products.
-CAPA Coordinator role - Liaising with suppliers, customers and cross functional teams in the resolution of CAPA

This position is ideally suited to a college / degree graduate with a chemistry or material science background, with experience of working within a laboratory. Supervisory experience is also required. Experience of the testing and release of pharmaceutical products would be advantageous. To be able to carry out this role you will need to demonstrate:
-Ability to use various laboratory equipment (HPLC, FTIR, Atomic Absorbion) and materials with confidence and safety
-Experience of working within a laboratory, and working in line with GMP and GLP
-Knowledge of, or experience of working with ICH guidelines for Stability Testing
-Trained auditor in both internal and External audits
-Experience of using and working with computerised QMS systems.
-Understanding the requirements for validation, the validation stages to be completed for processes, products and methods. An understanding of the requirements for software validation is beneficial.
-Experience of working with Risk Management / FMEA
-Experience of working with CAPA systems and Deviation system, and understanding the fundamental requirements of such systems. Including knowledge of problem solving and root cause analysis techniques

Knowledge of Quality Systems such as ISO 9001:2008, ISO13485:2003 and the MHRA Rules and Guidance (GMP) would be advantageous.

Please apply online for immediate consideration.


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