Regulatory Compliance Specialist
hace 16 horas
Job Description
The Qrc Group, LLC is looking for a highly skilled and experienced Aseptic Operations Lead to join our team. As an expert in aseptic processing, you will be responsible for ensuring high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA). Your primary focus will be on leading efforts in the design, commissioning, implementation, and improvement of aseptic processes and systems.
Key Responsibilities
- Lead the design, commissioning, implementation, and improvement of aseptic processes and systems.
- Troubleshoot and resolve issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines.
- Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.
- Review and prepare technical data for inclusion in regulatory submissions, ensuring compliance with FDA requirements.
- Provide input on regulatory requirements and assist in ensuring that products meet regulatory expectations for approval.
- Develop, execute, and document validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment.
- Lead investigations for deviations and CAPAs related to aseptic operations, ensuring timely and effective resolution.
Requirements
A degree in Engineering, Pharmaceutical Sciences, or a related field, along with 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment, is required. Strong knowledge of aseptic processing and systems (e.g., filling lines, isolators, lyophilizers), as well as expertise in validation methodologies (IQ/OQ/PQ) and risk management, is essential.
Bonus Skills
- Familiarity with FDA regulations, cGMP guidelines, and industry standards (e.g., ISO).
- Experience with process improvement methodologies (e.g., Lean, Six Sigma).
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