
ASEPTIC Manufacturing Regulatory Expert
hace 2 días
Job Description
Overview: Qrc Group, Llc is dedicated to delivering high-quality services in the pharmaceutical industry. We are seeking a talented Regulatory Consultant to join our team.
Key Responsibilities:
- Develop and implement regulatory strategies for aseptic manufacturing processes.
- Review and revise regulatory documents, ensuring accuracy and adherence to FDA guidelines.
- Analyze facility designs to ensure compliance with FDA regulations.
- Stay current with FDA regulations and industry standards for aseptic processing.
- Collaborate with cross-functional teams to prepare and submit CAPA plans.
Essential Qualifications:
- Relevant Bachelor's degree (Master's preferred).
- Minimum 5 years of experience in regulatory affairs, specifically in aseptic manufacturing.
- Proven expertise in FDA regulations and aseptic processing guidelines.
- Experience in supporting FDA inspections and audits.
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