Kirit Kalasariya
@kiritkalasariya
Experienced professional in Pharma R&D Quality with 16 years' expertise.
What I'm looking for
Looking for Challanging Quality Role
Experience
Work history, roles, and key accomplishments
Quality Manager
Pharmanovia India Pvt Ltd (Atnahas Pharma UK)
Oct 2023 - Present (1 year 8 months)
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.
Manager DQA
Vergo Pharma Research Laboratory Pvt Ltd
Aug 2020 - Oct 2023 (3 years 2 months)
Led a team to maintain quality standards, evaluated API and excipients, and managed document systems. Participated in computer system validation and escalated quality issues.
Quality Manager
Rubicon Research
Jun 2023 - Oct 2023 (4 months)
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.
Dy. Manager DQA
Naari Pharma Pvt Ltd
Jun 2018 - May 2020 (1 year 11 months)
Managed quality support for hormonal product development, implemented review systems, and ensured compliance with regulatory requirements.
Asst. Manager DQA
Dr. Reddy's
Jul 2016 - Jun 2018 (1 year 11 months)
Provided quality support for product development and ensured compliance in high potent labs. Assisted in dossier leverage products for international markets.
Scientist II, Quality (R&D)
Torrent Research Centre
Apr 2016 - Jul 2016 (3 months)
Conducted quality and compliance activities during product development, supported pilot batches, and facilitated vendor qualification.
Officer MFG (OSD)
Intas Pharmaceutical Pvt Ltd
Jan 2007 - May 2008 (1 year 4 months)
Supervised capsule filling and coating processes, participated in regulatory audits, and initiated standard operating procedures.
Jr. Officer MFG
Unique Laboratories (J B Chemicals)
Oct 2005 - Jan 2007 (1 year 3 months)
Handled dispensing of raw materials, conducted granulation operations, and supervised compression and coating activities.
Education
Degrees, certifications, and relevant coursework
Saurashtra University
Master of Pharmacy, Pharmaceutical Sciences
2008 - 2010
Completed a Master of Pharmacy focusing on advanced pharmaceutical sciences, including drug formulation and development, pharmacology, and quality assurance.
Sardar Patel University
Bachelor of Pharmacy, Pharmacy
2002 - 2005
Earned a Bachelor of Pharmacy degree, gaining foundational knowledge in pharmaceutical chemistry, pharmacognosy, and clinical pharmacy.
South Gujarat University
Diploma in Pharmacy, Pharmacy
2000 - 2002
Obtained a Diploma in Pharmacy, focusing on essential pharmaceutical practices and the basics of drug formulation and dispensing.
Availability
Location
Authorized to work in
Social media
Job categories
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