Pradip Prajapati

Product Manager

Vadodara, Gujarat, India4 yrs 11 mos experience

Key Highlights

Expert in Analytical Method Development and Validation
Strong background in regulatory compliance and quality control
Proficient in handling diverse drug products

Stackforce AI infers this person is a Pharmaceutical Quality Control Specialist with expertise in analytical methods.

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Skills

Core Skills

Analytical Methods DevelopmentAnalytical Method Validation

Other Skills

Analytical InstrumentsAnalytical R&DQuality ControlcGMPGLPICH Guidelinesregulatory complianceAnalytical SkillsMicrosoft ExcelGC-MSGC-FIDGas ChromatographyAnalytical ChemistryWritingResearch and Development (R&D)

Experience

Ami lifesciences pvt. ltd.

Senior Officer

Mar 2025 – Present · 1 yr · Vadodara, Gujarat, India · On-site

Experience in Analytical Method development, Method optimization and method validation with reputed organizations. In-depth knowledge of Analytical R&D, Quality Control, cGMP, GLP, ICH Guidelines and regulatory compliance.
Handled various drug products like API molecules, KSM and Raw materials.
Good expertise in Analytical Method optimization and Validation, Method Verification, Feasibility study for drug substance according to ICH,Pharmacopoeia (EP, USP & JP).
Method development, Method Validation and verification of Cleaning Validation, Force degradation and Admixture study.
Knowledge of DRL query, CRL query and ANDA file submission.

Analytical InstrumentsAnalytical Method ValidationAnalytical R&DQuality ControlcGMPGLP+3

Alembic pharmaceuticals limited

Jr. Executive

Apr 2022 – Mar 2025 · 2 yrs 11 mos · Vadodara, Gujarat, India · On-site

Experience in Analytical Method Validation with reputed organizations. In-depth knowledge of Analytical R&D, Quality Control, cGMP, GLP, ICH Guidelines and regulatory compliance.
Handled various drug products like Injectable, Ophthalmic, PFS, Peptides and API molecules.
Good expertise in Analytical Method Validation, Method Verification, Feasibility study for drug substance and drug product according to ICH,Pharmacopoeia (EP, USP & JP).
Method Validation and verification of Cleaning Validation, Force degradation and Admixture study.
Knowledge of DRL query, CRL query and ANDA file submission.

Analytical InstrumentsAnalytical Method ValidationAnalytical R&DQuality ControlcGMPGLP+3