Provide strategic guidance in the preparation of quality related regulatory documentation.
Manage and conduct audits to ensure compliance to GCP/GLP Standards, International Guidelines, Regulatory Requirements, Legislation, Study Protocols, Policies, Standard Operating Procedures, System Requirements, Supplier Agreements and Facility Standards, including:
study specific audits on the critical phases identified for a study;
audits on study protocols and study report, including amendments;
system/facility and process audits as per audit plan;
other directed audits;
Asses, investigate and resolve deviations.
Manage and perform supplier sub-contractor audits and the resolutions on findings.
Issue audit reports and document findings.
Develop, recommend and monitor corrective and preventative actions and communicate to relevant management.
Manage sponsor audits and regulatory inspections.
Monitor employee training in GCP principles and Quality Assurance SOPs.
Report findings to The Board of Directors and Site Management.
Independently identify opportunities and the need for business and process improvements.
Mentor and support employee training and development, promoting a culture of excellence in a performance driven environment.
Job Details
| Date Posted: | 2017-02-16 |
| Job Location: | Mohammedia, Morocco |
| Job Role: | Research and Development |
| Company Industry: | Laboratory/QC |
Preferred Candidate
| Career Level: | Management |
| Degree: | Master's degree |
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