QA Professional managing quality assurance and audits in pharmaceutical logistics. Responsible for documentation and compliance with regulatory standards in a decentral location.
About the role
- Supports and assesses quality and compliance processes in healthcare at Grifols. Engaging in audit planning, regulatory inspections, and ensuring adherence to quality standards.
Responsibilities
- Supports and assesses activities to ensure adherence to quality and compliance processes
- Coordinates with donor centers for external inspections
- Aids with audit planning and responses
- Responsible for developing and reviewing audit responses / CAPA plans
- Ensures compliance with Domestic / European regulations through routine review
Requirements
- Bachelor’s Degree Required
- 5 years of experience
- Knowledge of the Code of Federal Regulations (CFR)
- Understanding of the European Pharmacopoeia (EP) and other European Guidelines
- Ability to write clear, concise, logical responses to regulatory authorities
- Strong interpersonal skills
Benefits
- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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