# I have 12 years of qualitative experience in Compliance Management, Quality Assurance & Control, Process Enhancement, Training & Development, Raw Material and finished product Testing & Inspection.# Endowed with combined multidisciplinary experience in Quality Control with different Industries (i.e. API, Intermediate and Formulation).# Troubleshooting of analytical instruments like GC, HPLC, Milli-Q-water System, KF Titrator, UV Spectrophotometer, FTIR, Polarimeter.#Exposure to facing Audits of FDA and Customer Audits in India.#Experience in the usage of analytical methods transfer of substance in line with the quality parameters.# supervising the quality control of the laboratory by performing all QA/QC procedures for analytical tests, calibration and verification of instruments.#planning and allocation of daily work.#Review of Chromatographic sequences and analytical data.#Electronic verification of chromatographic data in Chromeleon Software.#Monitoring of Part-11 compliance in QC lab for all instrumental analysis.# Handling of Laboratory Incidents, OOS, OOT, Change control, deviations and CAPA.# Maintaining internal, external calibration and preventive maintenance schedule.#Review and release of Finish Product, Stability, Raw materials analytical Reports .# Responsible for preparation of weekly reports and Monthly reports and send to management.# Responsible for inventory management system.# Procurement of new instruments and equipment’s as per requirement.# Responsible for Instruments Qualification and analyst qualification activity.# Responsible for Training Schedule and execution for new employees.# Preparation and Review of job description for new employees and imparting training.# Maintaining of Working standard and reference standard as per requirements.# Preparation and Review of SOP’s and Specifications.# Release activity of Raw Material, Intermediate and API.# Management of external lab analysis of API samples.# To support during Customer, Internal Audit and Compliance of Observations.# Analytical Instruments:- Gas Chromatography (Perkin Elmer Clarus 680, Agilent 7890A and Shimadzu GC2014 and GC2010 )- High-Performance Liquid Chromatography (Agilent 1100 and Shimadzu LC2010) - UV-Visible Spectrophotometer (Shimadzu UV-1800, Perkin Elmer Lamba 40)- Karl Fischer (Metrohm 870 Titrino Plus, Mettler Toledo V20S ,Veego Matic-D)- Potentiometer (Metrohm 870 Titrino Plus)# Instrument Software Experience: Perkin - Win lab 32, Shimadzu - lab solution, Thermo fischer scientific – Chromeleon 6.8 and 7.2.