Mala Patel Email and Phone Number

 Responsible for quality audit, quality control, manufacturing and packaging for ISO: 9001 certified chemical manufacturing company.  Direct a team of QA officers to meet the quality control requirements.  Develop analytical method for quality control for fine chemicals.  Diagnose root cause analysis of customer complaints and suggest recommended modifications. Develop new test procedures and specifications towards newly developed compounds as per customer requirements.

 Developing analytical methods for assay of active ingredients as well as impurities profiling.  Performed analysis of degradation impurities and related substance studies for dental products as well as analysis of raw materials, pre-formulation studies and finished products. Analysis for all forms of products such as tablets, liquids, and gel.  Analysis of stability samples and method validation.  Work under GMP and GLP laboratory conditions within FDA guidelines. Documenting tests and results in notebook and worksheets, assuring compliance with GMP.

 Development and management of R&D projects and method validation.  Developing analytical methods for a i quantification, impurity determination as well as degradation and dissolution studies for new formulations. Develop and validate analytical method for analysis of various types of formulations including tablets, liquids, and capsules. Ensuring GMP and GLP compliance is ascertained within FDA guidelines towards all existing and developments products and processes.

 Method Development for newly developed formulations, conducting studies and report preparation.  Drafting SOP's (Standard Operating Procedures), Study protocols, Validation protocols and summary reports.  Calibration of analytical instruments in the lab.  Develop HPLC (UV/Vis) methods for AI quantification and impurity determination in raw materials as well as finished products of solid dosage forms (capsules and tablets) and liquids.