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Vacancy details
Vacancy description:
Job Code:
J756742
Job Title:
Senior QA Quality Assurance Officer
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
QA, Regulatory Affairs
Country:
United Kingdom
Location:
Berkshire, Hampshire, London - Central, Surrey, London - North, London - East, London - South, London - West
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Primary Purposes of Position:
This progressive and innovative company is now looking for a Senior Quality Assurance Officer, to perform audits and to assist in the development of a quality system, in order to support and promote the overall quality improvement of company drug development activities and therefore to help achieving clinical excellence.
Main Duties to be performed:
Audits & Inspections
• To contribute to scheduling audit activities of the drug development programme.
• To plan and conduct audits of company drug development activities in an accurate and timely manner, in accordance with company standards (Eg. company Global SOPs), Good Clinical Practices (GCP) and other applicable regulations.
• To liaise with the staff in charge of the audited activities, provide recommendations and ensure that corrective actions are satisfactorily recorded and audit outcomes are reported to management.
• To assist in the preparation and follow-up of any regulatory inspection in conjunction with other QA management.
Validated Global Development & Regulatory GxP Applications
• To plan and conduct audits of software suppliers in collaboration with Development & Regulatory Informatics department, as well as audits of validated Global Development & Regulatory GxP Applications. To liaise with the staff in charge of the audited activities, provide recommendations and ensure that corrective actions are satisfactorily recorded and audit outcomes are reported to Development management.
• To participate in Global Development & Regulatory GxP Applications validation teams, in order to ensure that those systems are undergoing and maintaining appropriate validation, in order to meet applicable regulatory requirements.
SOPs and Working Instructions
• To prepare and develop Quality Assurance SOPs and IQA Working Instructions.
• To be an active participant of the SOP or Working Instruction Committees
• To assist with developing other company Global SOPs, Working Instructions and local SOPs.
• To assist with distributing and archiving Global SOPs.
• To develop any other tool (Eg. Audit checklists), aimed at describing and harmonising IQA activities within the team.
Advisory/Support role
• To maintain a personal current awareness of regulatory requirements regarding GxP compliance and other quality standards.
• To provide support to company staff, by informing and advising about GCP, regulatory, SOP and guideline/Working Instructions requirements in a timely manner.
• To participating in project teams set up within drug development providing quality assurance recommendations and support for overall team objectives.
Education:
• Life Science degree (or equivalent)
Skills:
• Ability to work autonomously as well as proven ability to work as part of a team
• Ability to meet deadlines
• Proven adaptability
• Excellent communication skills
Travelling requirements: The job holder will be asked to travel to Europe, US and to the other company affiliates as required. 1-3 days stay may be necessary for Europe and almost 1 week for the US.
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