Nikita Mhatre

Experienced Production Officer with 4+ years in Oral Solid Dosage formulation at Cipla Ltd. Proven expertise in sifting, blending, sizing, BMR documentation, and QMS compliance. Recognized for CAPA closure, process optimization, Qualifications of equipment and maintaining consistent product quality. Seeking to contribute to manufacturing excellence and continuous improvement in a regulated pharma environment.

Jr. Officer / Production Officer – Formulation (OSD) - Cipla Ltd. - Cipla Patalganga Unit II, Patalganga

(2021)

Experienced Production officer in Oral Solid Dosage (OSD) manufacturing within the Formulation Department.

• Improved shop floor performance, contributing to enhanced product quality and better yield outcomes.
• Performed sifting, blending, and sizing operations for Oral Solid Dosage (OSD) formulations.
• Maintained comprehensive documentation, including BMR (Batch Manufacturing Records), OOS (Out of Specification), OOT (Out of Trend), and CAPA records.
• Actively contributed to process improvements and optimization of manufacturing activities.
• Handling Change request in trackwise and Purchase Requisition in Ariba.
• Work as LMS co-ordinator in Granulation department. Revised SOPs as per audit findings and compliance requirements.
• Successfully supported USFDA audit (2024) by coordinating documentation, ensuring data integrity, and addressing audit queries in compliance with regulatory expectations.
• Assisted in closure of observations by preparing CAPA (Corrective and Preventive Actions) with root cause analysis and timely implementation.
• Actively participated in Local FDA audits, ensuring readiness of SOPs, batch records.
• Maintained compliance with regulatory guidelines and supported smooth audit execution with zero/minimal critical observations.
• Conducted and supported Vendor Audits for qualification and evaluation of suppliers as per GMP requirements.

Diploma In pharmacy - pharmacy - Bharati Vidyapeeth College of Pharmacy, Belapur (2021 - 2021)

B Pharmacy - pharmacy - Raigad College of pharmacy, Mahad, Raigad (2021 - 2025)