Do you have experience of QA within the Clinical environment? If so this could be the role that you are looking for. QA Manager needed for a Pharmaceutical Company
The Role and your Responsibilities
- Perform QA audits of clinical trial data in accordance with Good Clinical Practice (GCP) and with the relevant SOPs
- Perform system audits
- Be familiar with all relevant SOPs (QA, Clinical Research, General, Biometrics, Administration and IT) and with appropriate regulations and Good Clinical Practice
- Plan and conduct regular and random QA audits of the quality system (internal and external) in order to ensure that clinical studies managed by the company are of the highest standard and in compliance with the requirements of the company's SOPs, study protocols, ISO 9000 and Good Clinical Practice
- Ensure that audit results are formally recorded and reported and that corrective/preventive actions are implemented effectively
- Review critical documents prior to drug release
- Assist in training new QA auditors
- Keep the person to whom the QA Auditor reports to informed of any QA issues within the department which require attention
What is Required
- Appropriate experience within QA at a management level
- Ideally a good knowledge/background in medicine, science or other relevant disciplines
- Good oral and written communication skills
What is Offered
Based in Buckinghamshire, Good contract rates dependent on experience
Further details & applications
To find out more about this vacancy, or to apply, please contact
Elisabeth.Knighton@docs-int.com (
01273 735827).
