QA Executive

Proclinical is working with a laboratory company that is seeking a QA Executive to be based in Hertfordshire on a permanent basis. The main reponsibilty of this role will be to support the implementation, operation and continuous improvement of the company's Quality Management System ensuring compliance to legislative requirements and the company licences.

Job Responsibitlies:

• Identify and implement updates to the Quality Management System in line with internal and/or regulatory updates.
• Generate, review and update of documented procedures and controlled documentation.
• Coordinate and maintain records within the Quality Management System.
• Analyse and report on QC tests to ensure function sits within specifications.
• Support in the documentation and investigation of quality compliance related issues.
• Consider how the quality of SOP's can be improved.
• Interpret and implement quality assurance standards.
• Review, develop and implement various appropriate measures, efficiencies and tests of the processes and systems within the Quality Management System.
• Participation in and documentation of internal audits as required.
• Participation in/support for regulatory and third-party site audits.
• Investigate customer complaints and supplier non-conformance issues.
• Analyse data to identify areas for improvement within the Quality Management System.
• Prepare reports to detail issues, investigations and communicate outcomes of quality activities.
• Monitor risk management activities and consider impact of legislation on specific requirements.
• Responsible for document management systems.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Undertake other tasks related to the job objectives as directed by line management.

Skills and Requirements:

• Bachelors degree in a scientific subject preferred
• Minimum of 2 years related experience in a QA role within the Pharmaceutical industry
• Good working knowledge of GMP and GDP systems and processes
• Strong computer skills including Microsoft Office and databases
• Knowledge of tools, concepts and methodologies used within a Quality Management System.
• Knowledge of relevant current legislation for GMDP
• Knowledge of root cause analysis and ability to apply this to quality systems on a routine basis
• Accuracy and attention to detail
• Communication skills - verbal and written
• Data collection, management and analysis
• Investigation, analysis and problem solving
• Planning and organising
• Decision-making and proactive work ethos
• Teamwork
• Ability to apply technical knowledge and understanding
• Ability to make appropriate and timely risk based decisions

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Green on +44 203 814 1317 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.