Assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, pharmacovigilance system audits, study specific audits (e.g. investigator site, in process, pharmacy/distribution, trial master file), country office audits and audits of vendors used to support PRAHS services.
Provides consultation, mentoring and compliance for the organization on GxP areas (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Consults with PRA staff for interpretation of regulations.
May have responsibility to support specific operations such as:
- Clinical Pharmacology Unit
- Bioanalytical Laboratory
- GMP Pharmacy
- Computerized Systems