Sejal Parab
Quality Assurance and Regulatory Affairs Intern at Akston
Based in Boston, United States
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Seniority
Staff
Department
Other
Location
Boston
Industry
Biotechnology
Company size
67
Contact information
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s•••••••@akstonbio.com
Phone
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Background
About Sejal Parab
Strategic and proactive Quality and Regulatory Compliance graduate student with hands-on experience supporting GMP compliance and regulatory activities for biologics, pharmaceuticals and medical devices. Good experience in quality document management and maintaining life cycle of GDP/GMP documents such as Batch Records, SOP, protocol, and reports. Supported document issuance, revision, retrieval, submission, training, and effectiveness of all GMP documents for various pharmaceutical functions. Recognized for strong cross-functional collaboration, attention to detail, and clear communication in supporting compliance readiness and continuous improvement efforts. Passionate about mitigating compliance risks and enhancing regulatory preparedness to ensure product quality and patient safety throughout the product lifecycle. Skills include document control, batch record review (MBRs, PBRs), deviation and CAPA tracking, SOP writing, regulatory submissions support, quality auditing, and QMS documentation using tools such as MasterControl and Veeva Vault.
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