Mihir B

P

Project Management Executive

Mar 2026 - Current (8 months)

Quality Assurance Specialist

Msd

May 2025 - Dec 2025 (8 months)

• Led cGMP quality auditing and review of documentation for drug substance/products and clinical finished goods. Ensuring compliance with EU Vol. 4 and MHRA.
• Conducted regulatory and GMP reviews of IMPD/BRCs for batch releases of investigational medicinal products.
• Implemented quality assurance protocols to ensure compliance with industry standards.

M

Analytical Development Chemist

Millicent Pharma

Apr 2024 - May 2025 (1 year 2 months)

Led the validation of analytical methods for drug substances and products, ensuring compliance with cGMP guidelines.
• Facilitated technology transfer of analytical methods across multiple sites.
• Provided technical support in the development of Contraceptive ODT and Vaginal Ring Systems and combination products.

Technical Services & Validation Trainee

Endo

Sep 2021 - Aug 2022 (1 year)

• Monitored and ensured compliance with FDA, cGMP, and ISO standards for tablet and capsule batches.
• Conducted process validation and optimization to ensure product quality and regulatory compliance.
• Developed and reviewed pilot/qualification and validation batch protocols.
• Managed quality aspects from development to market release, including manufacturing and packaging processes.

I

Industrial Training Internship

Jan 2021 - Feb 2021 (2 months)

• Reviewed various documentation to ensure compliance with regulatory guidelines and quality standards.
• Assisted in quality investigations by collecting data and providing inputs for corrective actions.
• Supported training department by maintaining records and ensuring compliance with training requirements.

D

Drug Development Intern

Dec 2020

• Contributed to the design and synthesis of New Chemical Entities (NCE) for drug development.
• Conducted in vitro microbiological assays and in vivo animal models to identify potential drug candidates.
• Participated in toxicology studies, ensuring compliance with regulatory standards.

R

Research And Development Intern

Dec 2019

• Assisted in formulation and process development for nutraceutical products as OSD tablets and capsules.
• Participated in manufacturing nutraceutical batches for product development and stability testing.
• Coordinated with cross-functional teams (R&D, Quality Control, Manufacturing) during the internship.

Quality Assurance Intern

Sandoz

Dec 2018 - Jan 2019 (2 months)

• Conducted internal audits to ensure compliance, supported audit readiness, and participated in Quality System audits.
• Streamlined quality processes through SOP development and implementation, contributing to Change Control and Document Management.
• Managed documentation control, supported regulatory inspections, and handled deviations and investigations.

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Mihir B

About

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Behavioral traits