What are the responsibilities and job description for the Quality Compliance & Risk Analyst position at cGxPServe?
Job Description
Job Description
Responsibilities :
- Perform risk assessments for manufacturing operations, product quality, and regulatory compliance.
- Identify, evaluate, and document potential quality risks and propose effective mitigation strategies.
- Utilize risk assessment methodologies such as FMEA, Risk Priority Number (RPN), and Fault Tree Analysis (FTA).
- Ensure adherence to FDA, ISO 9001, GMP, and other industry compliance standards.
- Maintain and update risk assessment documentation to reflect compliance and process improvements.
- Collaborate with cross-functional teams to implement risk controls and best practices.
- Support continuous improvement initiatives by identifying risks and contributing to CAPA processes.
- Develop and deliver risk management training for internal teams.
- Prepare and present risk assessment findings to senior leadership and regulatory agencies.
Requirements :
