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SONALI NIKAM

@sonalinikam

Assistant Professor at Government College of Pharmacy, with pharmaceutical QA experience at Ajanta Pharma Limited and published clinical and scientific reviews.

India

Message

What I'm looking for

I’m seeking clinical research or medical writing roles where I can apply my experience handling QMS, regulatory compliance, and protocol adherence to support high-quality, GCP-compliant clinical trial operations and audit readiness.

At Government College of Pharmacy, I deliver lectures and lead discussions on pharmacology topics, including pharmacokinetics, pharmacodynamics, toxicology, and clinical pharmacology. I also design question papers, clinical case studies, quizzes, and practical evaluations.

At Ajanta Pharma Limited, I managed QMS frameworks, investigated deviations using 5 Whys and Fishbone methodologies, and prepared for regulatory inspections. I’ve also authored and contributed to published pharmaceutical reviews, and I’m seeking clinical research or medical writing roles where I can apply my experience with quality systems, regulatory compliance, and protocol adherence.

Experience

Work history, roles, and key accomplishments

Current

Assistant Professor

Current

Government College of Pharmacy

Jan 2026 - Present (9 months)

Delivering lectures and leading discussions on core pharmacology topics such as pharmacokinetics, pharmacodynamics, toxicology, and clinical pharmacology. Designing question papers, clinical case studies, quizzes, and practical evaluations to test student knowledge.

Pharmacology Pharmacokinetics Pharmacodynamics Toxicology Clinical Pharmacology Curriculum Design Student Assessment

Assistant Professor

Lokmanya Tilak Institute of Pharmacy

Jan 2022 - Dec 2024 (2 years 11 months)

Delivered lectures and led practical sessions on ICH, cGMP, TQM, Analytical method validation, quality assurance technique, Pharmaceutics, Industrial pharmacy, Biochemistry, and Pharmaceutical Analysis. Mentored undergraduate students in experimental methods and designed experiments in formulation, managing data collection and analysis for research manuscripts.

ICH Guidelines GMP Quality Management Analytical Methods Validation Quality Assurance Pharmaceutical Industrial Pharmacy Biochemistry Pharmaceutical Analysis Mentorship Research Data Analysis Manuscript Writing

Assistant Professor

Yashodeep Institute of Pharmacy

Jan 2021 - Dec 2022 (1 year 11 months)

Directed the end-to-end administration of institutional examinations by managing logistics, timetables, and staff rosters while enforcing compliance and security protocols. Delivered lectures and led practical sessions in Pharmaceutical Sciences for undergraduate B. Pharm students, and mentored students on research projects and lab safety.

Examination Administration Compliance Pharmaceutical Industrial Pharmacy Curriculum Design Student Mentoring Lab Safety

Quality Assurance Officer

Ajanta Pharma Limited

Jan 2017 - Dec 2020 (3 years 11 months)

Managed QMS frameworks, including deviations and CAPAs, and investigated process and laboratory deviations using 5 Whys and Fishbone methodologies. Led internal audits, prepared documentation for regulatory inspections, and successfully faced USFDA, CDSCO, FDA, and WHO-GMP audits with zero major non-conformances.