Summary
Work History
Education
Skills
Languages
Timeline
Generic

VIKAS ANDOJU

HARRISON,NJ

Summary

At Icelandirect, I spearheaded quality assurance initiatives, ensuring CGMP and GMP compliance and adherence to FDA regulations. My expertise in batch record review and SOPs significantly minimized production delays, while my collaborative efforts in cross-functional teams enhanced our quality systems. My proactive approach in inspections and audits underscored my commitment to maintaining the highest standards of product integrity and regulatory compliance.

Work History

Quality Assurance

Icelandirect
04.2024 - Current

I ensured that our manufacturing and quality control processes were in compliance with CGMP and GMP regulations, and I strictly followed FDA guidelines.

To minimize batch failures and production delays, I reviewed and approved batch records for accuracy, completeness, and regulatory standards.

Collaborated together with the teams in charge of manufacturing and quality control to make sure that batch records were finished on schedule and in accordance with legal requirements.

I closely monitored and controlled the encapsulation process to ensure the final dosage forms' integrity, quality, and uniformity.

I conducted inspections throughout the manufacturing process, both in-process and for final products, to verify adherence to specifications and promptly address any deviations.

In the formulation development process, I reviewed formulation protocols and made sure that all activities aligned with quality and regulatory standards.

I collaborated with cross-functional teams to address and resolve quality issues, including deviations, CAPAs (Corrective and Preventive Actions), and other compliance-related concerns.

Additionally, I supported routine internal audits to continuously improve our quality systems and maintain compliance with FDA and international guidelines.

I played a crucial role in the commercialization process by ensuring that all products met the necessary regulatory requirements for commercial release under FDA regulations.

Education

Master of Science - Business Analytics

SAINT PETERS UNIVERSITY
Jersey City, NJ
12.2023

Skills

    Quality Assurance Inspections

    Standard Operating Procedures (SOPs)

    Batch Record Review

    FDA Regulations

    Deviation and Incident Reporting

    Inspection

    Good Manufacturing Practices (GMP)

Languages

English
Native or Bilingual
Spanish
Limited Working
Hindi
Native or Bilingual

Timeline

Quality Assurance

Icelandirect
04.2024 - Current

Master of Science - Business Analytics

SAINT PETERS UNIVERSITY
VIKAS ANDOJU