Summary
Overview
Work History
Education
Skills
Websites
Languages
Extracurricular Activities
Personal Information
Short Description
Affiliations
Languages
Timeline
Generic

Keyur Indrajit Solanki

Gir Somnath

Summary

Dynamic Quality Assurance Officer with proven expertise at Intas Pharmaceuticals Ltd, adept at managing QMS activities and executing impactful risk assessments. Recognized for strong problem-solving abilities and a commitment to compliance, I excel in enhancing product quality and safety while fostering teamwork and adaptability in fast-paced environments.

Overview

4
4
years of professional experience

Work History

Officer in QA

Intas Pharmaceuticals Ltd
Ahmedabad
04.2023 - Current
  • Managed Quality Management System activities, including deviations and investigations related to Out of Specification and Out of Trend in stability studies.
  • Conducted risk assessments and impact evaluations to ensure product quality, safety, efficacy, and patient safety in relation to stability study deviations, and Out of Specification / Out of Trend in stability studies.
  • Performed impact assessments on marketed batches to address Out of Specification and Out of Trend issues in stability studies, ensuring compliance and patient safety.
  • Executed QMS activities for stability and retained samples, including change requests and SOP preparation, to ensure continuous quality improvement.
  • Managed and resolved CAPA actions related to deviations and stability study irregularities, enhancing stability sample management efficiency.
  • Managed stability samples in alignment with change control actions, contributing to the ongoing improvement of quality standards.
  • Streamlined management processes for stability studies across solid oral, parenteral, ointment, and API products.
  • Conducted daily monitoring of stability chambers, ensuring accurate temperature and humidity records.
  • Compiled stability data and prepared summary reports to facilitate product evaluations.
  • Responsible for the destruction of stability samples after completing the stability study according to approved protocols.
  • Managed retention and periodic evaluation of samples for finished products, APIs, raw materials, packing materials, and KSM to ensure compliance with quality standards.
  • Conducted periodic observations and managed retention of samples for various materials, ensuring adherence to quality standards.
  • Oversaw sample retention and destruction processes, ensuring compliance with approved protocols and maintaining quality standards.
  • Managed the issuance, retrieval, and archival of controlled documents and SOPs.

Officer in QA

Exemed Pharmaceutical
Vadodara
04.2022 - 04.2023
  • Executed IPQA activities including area clearance, plant rounds, sampling of intermediates and finished products, and online process verification.
  • Monitored departmental activities and reviewed documentation for compliance and accuracy.
  • Managed control sample procedures, including destruction per SOP and product label reconciliation.
  • Ensured adherence to Standard Operating Procedures (SOPs) and compliance with Good Manufacturing Practices (GMP).
  • Initiated and compiled required activities in accordance with respective SOPs.
  • Issued, retrieved, numbered, and reviewed batch manufacturing records (BMR), batch production records (BPR), and other processing documents.
  • Compiled data for monthly Product Quality Review (PQR) and Annual Product Quality Review (APQR) reports, analyzing trends.
  • Prepared and distributed controlled copies of SOPs, calibration formats, and QMS-related forms.

Officer in QA

Zydus Life sciences
Ankleshwar
10.2021 - 04.2022
  • Executed IPQA activities, sampling intermediates and finished products for online verification in production area.
  • Ensured compliance with GMP by monitoring personnel practices in production area.
  • Participated in cleaning validation activities, conducting swab and rinse sampling per SOP.
  • Performed micro sampling to meet quality assurance standards outlined in respective SOPs.
  • Managed control sample processes, maintaining accurate destruction records and log books according to SOPs.
  • Coordinated loading and unloading of stability samples while monitoring their adherence to SOP guidelines.
  • Oversaw stability sample management, ensuring timely sampling and analysis as per established protocols.

Education

Master of Science - Organic Chemistry

Sabarmati University, Ahmedabad
Ahedabad
06-2025

B.Sc -

Government Science College
GANDHINAGAR
08.2020

HSC -

Modi School
Rajkot
04.2017

Skills

  • Scientific and numeric skills
  • Flexibility
  • Logical mindset
  • Independent mindset
  • Positive mindset
  • Good leadership
  • Problem solving
  • Enthusiastic person
  • Work determination
  • Reporting and documentation
  • Teamwork
  • Quality assurance
  • Self motivation
  • Adaptability and flexibility
  • Decision-making
  • Multitasking Abilities

Languages

  • English
  • Hindi
  • Gujarati

Extracurricular Activities

Black belt in Karate, NCC C-certificate, National Certificate in Handball (Federation and Inter University), State level certificate in Handball,  a NSS volunteer and having National Certificate in NSS Adventure certificates

Personal Information

  • Date of Birth: 05/18/99
  • Marital Status: Single

Short Description

I'm a nice, fun and friendly person, I'm honest and punctual, I work well in a team but also on my own as I like to set myself goals which I will achieve, I have good listening and communication skills. I have a creative mind and am always up for new challenges. I am well organized and always plan ahead to make sure I manage my time well.

Affiliations

  • I am honored with the Best Employee award and was recognized as the 5-star rated Employee of the Year in the QA department for year 2023 to 2024

Languages

English
First Language
Hindi
Proficient (C2)
C2
Gujarati
Proficient (C2)
C2

Timeline

Officer in QA

Intas Pharmaceuticals Ltd
04.2023 - Current

Officer in QA

Exemed Pharmaceutical
04.2022 - 04.2023

Officer in QA

Zydus Life sciences
10.2021 - 04.2022

Master of Science - Organic Chemistry

Sabarmati University, Ahmedabad

B.Sc -

Government Science College

HSC -

Modi School

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Keyur Indrajit Solanki