Spandana

Quality and Documentation Specialist

Summary

Spandana is a versatile Quality Specialist with over 10 years of experience in IT and pharmaceutical manufacturing. She excels in reviewing batch records, managing quality systems, and ensuring compliance with regulatory standards. Spandana has a proven track record in CAPA management, training administration, and supporting internal and external audits to uphold stringent quality requirements.

Core Expertise

  • Documentation Review 
  • Quality Systems Management 
  • Regulatory Compliance 
  • Training and Curriculum Development 

Career Highlights

  • QA Specialist, Sofgen Pharma: Reviewed and approved master and executed batch records, managed deviations and CAPAs, and oversaw employee training programs. 
  • Quality Training Specialist, Lab Connect: Developed and implemented role-specific training programs for US and EU employees, served as SME for ComplianceWire LMS, and provided KPI metrics for QMS management. 
  • QA Specialist II, Strides Pharma Inc.: Implemented electronic systems for compliance and material disposition, revised SOPs, and participated in regulatory audits to ensure compliance with GMP standards. 

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