Data Quality

Saumil Mehta

Cell: 630-***-****

Reading Road Apt 53p, NJ 08817

EMAIL: ********@*****.***

OBJECTIVE:

To seek challenging position in the Field of Pharmaceutical/ Biopharmaceutical industry as Quality Data Reviewer that provides an opportunity for acquiring skills and developing existing skill.

Perform accurate and timely Check and Review of Validation Batches / Quality samples, meeting current analytical procedures, SOPs, safety metrics and laboratory guidelines. Test pharmaceutical solid formulations and raw materials, implementing expertise in wide variety of instrumentation with emphasis on chromatographic methods and dosage from development. Interacts routinely with departments such as R&D, Validation, RA and QA.

Identify and resolve issues while meeting organization requirements and customer needs through accurate analyses and laboratory investigations documented in legible records and well-written reports.

Valued and effective team player, recognized for positive attitude, dependability, integrity and strong work proficient in:

•Chromatography: HPLC, UPLC: Water-Alliance, Agilent, and Shimadzu.

•Other techniques and instruments: KF, UV, Auto Titration, Dissolution and Wet Chemistry

Techniques

•Laboratory Software: LIMS, Empower, Chemstation, LC Solution.

•Computer Skills: Windows, Microsoft Office, Word, Excel.

Software Knowledge and Instrument Handled

•Empower network server software of waters (Build 1154), LIMS – Caliber Software.

•Empower 1, 2, 3 network server software waters Millennium 32 (ver. 3.2) Agilent LC 3D

Chemstation (Rev. A 08.03), Metrohm Auto titrate software Tiamo 836 and Tec an software Megallan5.

PROFESSIONAL EXPERIENCE:

Scientist II /Data Integrity

Amneal - Impax Pharma

Piscataway NJ USA. January 2019 –Continue

Working in Validation, Quality, Method Transfer.

Techinical Support and Review in Analytical Method Validation, Process Characterization, and Stability Data.

Check and Review accurate and timely manage on finished product and stability samples, releasing all products within assigned time.

Report Preparation and Review of Process Characterization and Process Validation.

Check and timely manage of Calibration of analytical instrument like HPLC/ UPLC, Dissolution apparatus.

Reviewing Lab data for PDTS, Validation Batches, and API as per LIMS (Laboratory Information Management System)

Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.

Reviews all electronic data audit trials in detail to ensure data integrity is not compromised in any way and ensure all signatures, electronics or Written are intact prior to the release of laboratory data.

Responsible for discussing data interpretation and questions with individual analysts and elevate to Management.

Responsible for verifying all laboratory testing was conducted in accordance with SOP as cGMPs.

Review of OOS reports to assure complete and compliant source data as per SOP.

Performing Routine lab audits to ensure the chemists are following cGLP in maintaining the instruments, using chemicals and reagents within their validity period, whether the chemical sand the HPLC vials are disposed as per SOP, log book entries and coloum entries are done during the analysis and timely documentation.

Operated the Instruments such as Dissolution, Auto Sampler (Dissolution) make Distek, Agilent, etc. HPLC and UPLC make Water, Agilent, and Acuity H Class.

Performed dissolution profile, and single point of solid dosage, following company SOPs and meeting cGLP documentation requirements.

Hands on experience of analytical instruments or techniques including HPLC, Dissolution& UPLC.

Work independently on analytical projects like ANDA& NDA, Method Validation & Process Characterization

Highly analytical professional with extensive experience in validation of analytical methods Dissolution Studies and Impurity Profile.

Knowledge of Quality, AR&D, Wet Chemistry & Analytical Chemistry

Stability experience is a strongly preferred stability studies requirement and expiration dates are covered in the current, GMP, USP and FDA.

Data Reviewer/ Data Integrity

Aurobindo/ Aurolife Pharma

Dayton NJ 08810 USA. June 2018 –January 2019

Working in QC &Validation.

Check and timely manage of Calibration of analytical instrument like HPLC/ UPLC, Dissolution apparatus.

Reviewing Lab data for PDTS, Validation Batches, and API as per LIMS (Laboratory Information Management System)

Responsible for ensuring the integrity of all data and documentation reported from the Chemistry Laboratory.

Reviews all electronic data audit trials in detail to ensure data integrity is not compromised in any way and ensure all signatures, electronics or Written are intact prior to the release of laboratory data.

Responsible for discussing data interpretation and questions with individual analysts and elevate to Management.

Responsible for verifying all laboratory testing was conducted in accordance with SOP as cGMPs.

Review of OOS reports to assure complete and compliant source data as per SOP.

Performing Routine lab audits to ensure the chemists are following cGLP in maintaining the instruments, using chemicals and reagents within their validity period, whether the chemical sand the HPLC vials are disposed as per SOP, log book entries and coloum entries are done during the analysis and timely documentation.

Operated the Instruments such as Dissolution, Auto Sampler (Dissolution) make Distek, Agilent, etc. HPLC and UPLC make Water, Agilent, and Acuity H Class.

ARD CHEMIST II /Data Integrity

Granulation Technology Fairfield NJ January 2017 to June 2018

Analytical Method Validation, Finished Product, and Stability Testing.

Performed accurate and timely analysis on finished product of solid dosage and stability samples, releasing all products within assigned time

Performed dissolution profile, and single point of solid dosage, following company SOPs and meeting cGLP documentation requirements.

Work independently on analytical projects like ANDA& NDA, Method Validation & Process Characterization

Highly analytical professional with extensive experience in validation of analytical methods Dissolution Studies and Impurity Profile.

Knowledge of Finished product Testing Wet Chemistry & Analytical Chemistry

Stability experience is a strongly preferred stability studies requirement and expiration dates are covered in the current, GMP, USP and FDA.

Stability Studies are routinely performed at various under condition of different temperature & Humidity (as per ICH guidelines) stability of R&D, Finished product samples.

ARD CHEMIST

Epic Pharma NY USA October 2014 to December 2016

Experience in various type of intermediate and raw material analysis,

Performed accurate and timely analysis on finished product of solid dosage and stability samples, releasing all products within assigned time.

ANDA & NDA Drug of analytical method develop & validation & Process Characterization by HPLC.

Have operational experience and handling knowledge of all type of QC instruments

Operated the Instruments such as Dissolution, ph meter,Auto titration, make Metrohm, Karl Fisher, make Ana lab and HPLC make Water, Agilent, & shimadzu. & UV & IR.

Performed dissolution profile and single point of solid dosage, following company SOPs and meeting cGLP documentation requirements.

Documented all laboratory testing, maintaining accurate and legible notebooks and records.

Organized time effectively, demonstrating strengths in planning and implementing projects.

Process and integrated chromatographic data, using chromatographic data systemEmpower.

Executive -Quality

Dishman-Carbozen Ahmedabad India March 1999 to January 2014

Development & Implementation of Quality Assurance guidelines in the organization of a new system and procedures.

In-Process Quality Control, Process Validation (DQ, IQ, OQ & PQ), Prospective validation Retrospective Validation, and Method Validation.

Standard operating procedures of Quality Assurance and their Implementation.

Quality Assurance Point of view look after the following responsibilities in the organization:

Personal Responsibilities

Building and Facility

Change Control/Revalidation

Laboratory Controls

Proper Documentation as per CGMP and GDP

Department wise Internal Audit as per CGMP norms

Documented all laboratory testing, maintaining accurate and legible notebooks and records.

EDUCATION:

•Master of Science in Organic Chemistry with Synthetic Drug

STATUS:

•US Citizen

* References upon request

Contact this candidate