> QA SME/ SENIOR PROJECT MANAGER

Over 18 years of experience in the Biopharmaceutical industry. Range of expertise includes Biological Facility startup, Process Engineering in a Biotech environment, Continuous Improvements, Quality Oversight, and Remediation Activities. With a vast experience in Life Sciences as a Consultant, who has worked directly to optimize the Quality Systems of multi-national clients. Highly experienced in FDA Quality Systems Regulation, cGMP, and other international QA standards.  

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• Manage and support Pre-Approval Inspection (PAI) readiness activities.

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• Assessment/ remediation of Quality Systems (related to Manufacturing, QC, Warehouse, Engineering and Quality departments) required to manufacture cGMP clinical and commercial batches of biosimilar    products. 

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• Remediation and improvement of Supply Chain, CAPA, Document System, and Analytical Laboratories.

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• Coordinate training on regulatory and quality topics such as proper documentation procedures and the use of electronic quality systems. 

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• Facilitate review and revision of all cGMP MFG related SOP’s, plans, and policies.   

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• Quality oversight of manufacturing operations utilizing efficient batch record review processes and investigations. 

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• Change Control Owner. Revise and create GMP documents, and collaborate with QA, MSAT, Validation, Manufacturing to solve problems, implement process improvements and CAPAs via TrackWise.

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• Lead investigations and root cause analysis. 

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• Provide periodic review of Facilities Department documentation and records such as logbooks, preventative maintenance records, and work orders to assess for compliance with established quality standards, policies, and procedures. 

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• Maintain quality records and inspection reports pertaining to cGMP related equipment and systems such as HEPA filter certifications, airflow hood inspections, smoke studies, etc.