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Job Details

QA Auditor

Company: Key People Limited
Location: Reading
Reference: 1202-128
Closing Date: 20 May 14
Type: Permanent
Salary (£): 20,000 - 30,000
Benefits:

Job Summary:

Key People are recruiting for an QA Auditor (Entry Level) for our medium global CRO client

Requirements:

We have an exciting opportunity for a Quality Assurance Auditor within a medium sized global CRO.

Working in a success-orientated environment with excellent possibilities for your personal and professional advancement.

POSITION SUMMARY:

To provide auditing and Quality Assurance activities in order to assure that the systems, processes and performance of the company comply with applicable laws, regulations, Standard Operating Procedures, protocols and guidelines, and meet Sponsor and Company requirements.

ESSENTIAL JOB FUNCTIONS:

Quality Assurance System:
• Assist with the maintenance of the global Quality Assurance System
• Assist in assuring Senior Management of the effectiveness of the Quality Assurance System and the quality of the deliverables
• Assist in the provision of QA review of SOPs prior to approval
• Input into process improvement initiatives across the company
Auditing Activities:
• Provide input into the development and maintenance of a global audit strategy and Quality Assurance function
• Prepare, review and provide input into Quality Assurance processes, and associated documentation
• Assist in the preparation and maintenance of a global audit schedule
• Organise, lead and participate in contracted audits (investigator sites, trial master files, database, study reports etc.) and internal audits (systems, processes, vendors, computer system validation etc.) across global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
• Assist in the preparation of reports to Senior Management documenting audit activities, metrics, findings and resolutions; and raise significant issues of non-compliance
• Assist in the training, liaison and supervision of contract auditors
• Promote quality principles throughout the Company
• Provide training to employees on ICH GCP, FDA regulations and other applicable regulatory standards
• Assist in coordinating and conducting company training programs
• Manage, host and support sponsor audits and Regulatory Authority inspections
• Provide a Quality Assurance consultancy service for questions and issues raised by Company personnel


Other Activities:
• Provide input into business planning activities as necessary
• Assist Business Development in representing Company services to sponsors
• Perform other duties that may be assigned or assumed as time and/or circumstances necessitates

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

• At least 3 years auditing experience in both Europe and North America (including database, trial master file, investigator sites, statistical/clinical study reports, vendors, process/systems, for cause audits, computer system validation audits etc.)
• Knowledge of ICH GCP, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations
• Experience in hosting and responding to regulatory inspections preferred



Key People:

"auditor" "QA" "CRA" "auditing" "Quality assurance" "GCP"

Apply for this job: QA Auditor

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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