PRA Health Sciences
Assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations
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
- Computerised Systems
- Knowledge of GxP, regulatory requirements which impact company policies, directives, and procedures.
- Good knowledge of the drug development processes, regulation awareness and scientific terminology.
- Good knowledge of SOPs and related documentation in a regulated industry.
- Proficiency in operating computers applications and navigating the internet.
- Excellent organizational skills, be logical, systematic and curious; must be able to gather and interpret relevant information; ability to work in a high volume and strict deadline environment.
- Ability to work in a high volume and strict deadline environment.
- A thorough understanding of drug, biologics and device clinical trial development processes
- Assist with the implementation of the audit programs
- Act as project-specific liaison and provide input for audit plans.
- Must have experience presenting conclusions in a clear and concise manner.
- Read, write and speak fluent English; fluent in host country language preferred.
- 2+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
- Excellent verbal and written communication skills, interpersonal skills.
- Excellent organizational skills.
- Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas.
- An undergraduate degree, its international equivalent in health sciences, pharmacy, laboratory, clinical research, and/or auditing, etc. from an accredited institution or sufficient previous experience in auditing is preferred.
- Experience working within a clinical research organization.
- Experience in Quality Assurance function is strongly preferred.
- Clinical site monitoring, GxP quality assurance auditing, and GxP regulations.
To qualify, applicants must be legally authorized to work in the United States/Canada and should not require, now or in the future, sponsorship for employment visa status.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.