
Aseptic Manufacturing Expert
hace 1 día
Job Description
The Qrc Group, Llc seeks a seasoned professional to provide expert regulatory guidance and support in navigating the aseptic production environment. As an Aseptic Manufacturing Expert, you will play a critical role in ensuring compliance with FDA and global regulatory standards.
Responsibilities:
- Provide expert regulatory advice for aseptic manufacturing processes.
- Prepare and review regulatory submissions to the FDA.
- Assess and advise on the regulatory aspects of facility design.
- Stay up-to-date with FDA regulations and industry standards for aseptic processing.
- Support the preparation and submission of CAPA plans and responses to regulatory authorities.
Requirements:
- 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.
- Strong understanding of FDA regulations and aseptic processing guidelines.
- Experience in preparing for and supporting FDA inspections and audits.
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