Regulatory Expert for Aseptic Manufacturing
hace 5 días
At Qrc Group, Llc, we are seeking an experienced Regulatory Consultant to provide expert guidance and support in navigating the regulatory landscape of aseptic production environments.
Key Responsibilities:
- Provide expert regulatory advice for aseptic manufacturing processes, ensuring compliance with FDA and global regulatory standards.
- Prepare and review regulatory submissions to the FDA, guaranteeing timely and accurate submission of required documents.
- Evaluate and advise on the regulatory aspects of facility design, including clean room and aseptic manufacturing areas, to ensure compliance with FDA guidelines.
- Stay up-to-date with FDA regulations and industry standards for aseptic processing and pharmaceutical products.
- Support the preparation and submission of Corrective and Preventive Action (CAPA) plans and responses to regulatory authorities.
Required Skills and Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or related field (Master's preferred).
- 5+ years of regulatory experience within the pharmaceutical or biotechnology industry, with a focus on aseptic manufacturing and FDA product submissions.
- Strong understanding of FDA regulations and aseptic processing guidelines.
- Experience in preparing for and supporting FDA inspections and audits.
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