With more than 30 years’ experience in hiring our own CRO staff as well as providing clinical personnel under contract to biotechnology, pharmaceutical, device and diagnostic companies, Chiltern is an industry leader known for providing career development opportunities and service excellence. That means we’re always seeking the best candidates to fill the needs of our global customers.
Post : QA Audit Associate(entry level position)
Job Background
- Assist with creation of SOPs required for the proper functioning of the clinical trial process. When instructed by QA Management, assist with evaluating and updating QA SOPs.
- With guidance from line management and experienced colleagues, audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and escalate the issue with the Project Manager; and if required, with Chiltern Senior Management.
- With guidance from line management and experienced colleagues, conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
- Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
Duties & Responsibilities
1) Ensure timely completion and documentation of all training requirements.
2) Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance.
3) Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations.
4)Other duties, as required by the Quality Assurance department.
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Requirements
Prior clinical research or compliance experience is considered beneficial.
Diplomatic and professional oral and written communication skills to be able to convey and discuss audit findings, good organisational skills and personal presentation.
Methodical and meticulous, with excellent attention to detail
Ability to proactively manage multiple responsibilities and tasks
Understanding of the principles of ICH- GCP and all applicable regulatory requirements
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