B. Saritha Kumari

Dedicated and experienced Pharmaceutical and Biotech professional seeking a challenging role in quality assurance, regulatory compliance, and project management. Utilize self expertise in QMS, APQR, and CAPA to drive quality excellence and ensure regulatory compliance.

Highly experienced Quality Assurance professional with 9.2 years of experience in the Pharmaceutical industry, specializing in QMS and APQRs preparation. Proven track record of ensuring compliance with regulatory requirements and industry standards

• Achieved Andhra Pradesh State Council of Science and Technology (Young Scientist Fellowship) for the year 2006-07 in M. Phil (Microbiology).
• I had given Radio talk (Interview) in PARISHODHANA Program in All India Radio as Yuva Shastrvethha.

• Managed and maintained the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards.
• Prepared and submitted Annual Product Quality Reviews (APQRs) to regulatory authorities.
• Conducted internal audits and ensured corrective actions were implemented to address any non-compliances.
• Collaborated with cross-functional teams to ensure quality standards were met throughout the product lifecycle.
• Provided training and guidance to junior staff members on QMS and APQR requirements.
• Managed and implemented change control processes to ensure regulatory compliance and minimal disruption to operations and coordinated with cross-functional teams to assess, approve, and implement changes.
• Investigated and resolved deviations, ensuring root cause identification and corrective action implementation.
• Developed and implemented corrective and preventive actions (CAPA) to address quality issues and regulatory non-compliances. Ensured effective execution and sustainability of CAPA plans.
• Managed and resolved market complaints, ensuring prompt investigation and response.
• Collaborated with quality, regulatory, and customer service teams to address customer concerns.
• Preparation of Management Review Meeting (MRM) reports.
• Participation in Internal audits and Customer audits.
• Actively Participated in major audits like WHO-GMP, ISO 9001:2015, customer audits, Regulatory audits and License renewals etc.

• Published Two Full Length Research Papers in International Journals:
• African Journal of Microbiology Research. Vol 3 (1) pp.010-014, January, 2009.
• Malaysian Journal of Microbiology. Vol 6 (2) pp. 133-139, December, 2010.

• Husband's Name: Madhukar Varma
• Date of Birth: 06/05/1982
• Nationality: Indian
• Marital Status: Married
• Religion: Hindu