Drashti Bhalala

Result oriented professional and Seeking a Position in Bio-Pharma that can Provide a Steady growth and Learning Opportunity to Practice my Practical Experience Extensively.

Executive - Kashiv Research Pvt. Ltd. - Ahmedabad, Gujarat

(2026-02)

Contribution to a Greenfield Project

• Review of IQ, OQ & PQ Protocols and Reports to ensure compliance with GMP requirements and approved validation procedures.
• Review of Batch Manufacturing Records (BMRs), QAMS Documents and Oversee IPQA activities across manufacturing operations, ensuring GMP compliance, product quality, and regulatory adherence.
• Handling of QMS Activities including Change Controls, Deviations, CAPA, OOS, Risk Assessments, and Training Records.
• Preparation, review, and control of Risk Assessment, SOPs, Protocols, Reports, Specifications, and Quality Documents.
• Support MasterControl Implementation activities including document migration, workflow configuration, user acceptance testing, system validation support to enhance digital quality management processes.
• Support for Internal, Customer, and Regulatory Audits and ensured GMP, ISO, and Quality System compliance.
• Coordination with Production, Quality Control, Validation, and Engineering Teams to ensure adherence to GMP and Quality System requirements.

Executive - Reliance Life Sciences - Navi Mumbai, Maharashtra

(2022-09 - 2026-02)

Upstream Processing, Production of Ranibizumab, r-tPA (Recombinant Tissue Plasminogen Activator), GCSF (Granulocyte Colony-Stimulating Factor) By Fermentation Using E. coli

• Execution of Validation Batches, Process Performance Qualification (PPQ) batches and Commercial Batches of Ranibizumab, r-tPA & GCSF.
• Designing & Execution of e-BMR in PASX.
• Experienced in QMS documentation, LIMS sample management, SAP operations, and TrackWise workflows.
• Led deviation, change control, and CAPA management while supporting PQ activities and ensuring GMP compliance.

Master of Science - Biotechnology - Rajiv Gandhi Institute of Information Technology and Biotechnology, Bharati Vidyapeeth University (2022)

Bachelor of Science - Biotechnology - Shree Ram Krishna Institute of Computer Education and Applied Sciences (2020)