Propharmagroup
GCP Compliance & QA Consultant.
United States
Sponsorship not specifiedDetected 30 days ago
ExpressGCPProduct ManagementAuditingClinical TrialsClinical ResearchGMPFDA RegulatoryPharmacovigilanceResearchCommunicationGxP
About the role
- Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
- Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
- With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
Responsibilities
- ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
Requirements
- Bachelor's degree, or similar college degree, in a scientific discipline as a minimum
- Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance
- Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations.
- Participate in the sales process as required and identify scope and effort required to successfully address client needs.
Nice to have
- A graduate degree (MSc / PhD) in a scientific discipline is preferred.
Skills
- Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge.
- Willingness and ability to travel as required.
- Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills.
- Quality orientation and high attention to detail.
- Strong analytical skills.
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