Kirit Kalasariya

Responsible for quality support during product development and new product launch, conducting audits, and ensuring compliance with CAPA. Engaged in quality due diligence and preparation of Quality Technical Agreements.

Led a team to maintain quality standards, evaluated API and excipients, and managed document systems. Participated in computer system validation and escalated quality issues.

Oversaw the review of CMC documents and coordinated with various departments to ensure compliance with regulatory requirements. Managed internal and external audits and approved QMS documents.

Managed quality support for hormonal product development, implemented review systems, and ensured compliance with regulatory requirements.

Provided quality support for product development and ensured compliance in high potent labs. Assisted in dossier leverage products for international markets.

Conducted quality and compliance activities during product development, supported pilot batches, and facilitated vendor qualification.

Supervised capsule filling and coating processes, participated in regulatory audits, and initiated standard operating procedures.

Handled dispensing of raw materials, conducted granulation operations, and supervised compression and coating activities.

Completed a Master of Pharmacy focusing on advanced pharmaceutical sciences, including drug formulation and development, pharmacology, and quality assurance.

Earned a Bachelor of Pharmacy degree, gaining foundational knowledge in pharmaceutical chemistry, pharmacognosy, and clinical pharmacy.

Obtained a Diploma in Pharmacy, focusing on essential pharmaceutical practices and the basics of drug formulation and dispensing.