Manager Qa Assistant

BHAGYESH CHAUHAN

***, “Devashish”, Sidhnath Nagar Society, G.H.B

Bharuch - 392001

Gujarat, India

Contact No: 00-91-982-***-****

E-mail: **********@*****.***

PROFESSIONAL PROFILE

An enthusiastic and dedicated graduate combining a strong academic background in Pharmaceutical Science with experience within the pharmaceutical industry. Adopts an analytical approach to all tasks and is highly computer literate. Able to work well on own initiative and to demonstrate the highest levels of motivation and organisation required to achieve objectives within strict time constraints. Possesses excellent interpersonal skills and can communicate concisely at all levels. Enjoys being part of, as well as supporting and motivating, a successful and productive multi-skilled team and thrives in pressurised and challenging working environments.

OBJECTIVE

I am now looking for a new and challenging position, one which will make best use of my existing skills and experience yet enable further personal and professional development.

SKILLS PROFILE

Technical Knowledge:

Utilize knowledge of GLP/GMP/Pharmaceutical guidelines in operating procedure

Basic understanding of pharmaceutical statistic

Practical knowledge of HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), RRLC (Rapid Resolution Liquid Chromatography), GC-MS (Gas Chromatography- Mass Spectroscopy), NMR (Nuclear Magnetic Resonance Spectroscopy), Dissolution Apparatus, Proof Reader, Magna mike meter, True scan Raman Analyser, Shadow Graph and Density meter, U.V/Vis Spectrophotometer, KF Coulometer, Karl Fisher for Water content, FTIR Spectrophotometer, Polarimeter etc.,

Experience in laboratory environment dealing with wide range of chemicals and testing techniques

Maintenance of technical records, calibration data & laboratory data collection and other experimental work

I.T. Proficiency:

Track wise, SAP, LIMS, Chromeleone, Empower3, Lab solution, Phenix, Labx, Lab solution, UV probe, QEdge, Windows 98/ME/XP, Microsoft Office 95/98/ME/XP/10, Oracle 8i, FoxPro, C, C++, D.T.P, FrontPage, Flash, Internet & Email

Skilled in the assembly of PC’s, Hardware installation, Software & Hardware fault diagnosis & Bios set-up

Languages: Fluent English, Hindi and Gujarati

EMPLOYMENT SUMMARY

Period: March 2022 – Till date

Organization: BGP Healthcare Pvt. Ltd, Ankleshwar, Gujarat, India

Designation: Assistant Manager, Quality Control

To assist & support QC manager & Sr. Manager QA/QC in daily management of Quality control functions/activities, including quality control inspection schedules

Review of daily calibration of all laboratory instrument/equipments (i.e. Analytical balances, pH meters, KF titrator etc.,), Temperature monitoring log of laboratory areas, Stability chamber reports etc.,

Reviewing of laboratory raw data, calibration documents, analytical reports of chromatogram system, FT-IR, UV & non chromatogram system, audit trail review, assessment of In-process samples, Intermediate samples, PD lab samples, stability samples, Raw materials, finish products samples, releasing of raw materials through manual procedure, preparation of stability summary sheet report for stability samples, in addition to preparation of manual COA’s accurately in legible writing for raw materials.

Undertaking various validation activities such as Excel Sheet validation & Scientific Calculator validation activities and administrative duties such as preparation of specification from USP/EP/IP monograph as well as Analytical raw data sheet, handling of laboratory incidence, unplanned deviation investigation using appropriate investigation tools, and change control of Quality control laboratory

Utilizing analytical knowledge, skills and experience to provide appropriate solution of instrument malfunction/errors/handling of instruments as well as troubleshooting of instruments at all times for efficient and effective work

Identifying the laboratory errors and offering viable suggestions for online corrections in order to produce and sustain high standards of performance, to reduce laboratory errors

Successfully participated at the time of local regulatory audits and other vendor audits.

Period: December 2021 – March 2022

Organization: Ginni Filaments Ltd, Panoli-Ankleshwar, Gujarat, India

Designation: Joint Manager, Quality Control – Consumer Product Division

To monitor the Quality control functions/activities of a project or its parts, including quality control inspection schedules

To support unit head for implementation of the Quality control plans on the site

To supervise installation of Laboratory furniture’s, Laboratory’s electrical installation as per approved designs, review design, communicate with vendors as & when required

To Evaluates the qualification of maintenance department instrument/equipments with respect to the activities assigned

To Support and participate to all the internal/external audits

To prepare IQ, OQ, & PQ documents of maintenance, engineering department & other department as and when required & support to complete qualification activities

To supervise inspection of site on-going activities and to cooperate with Site team to analyses of non conformities, offering viable suggestion for online corrections, conducting training to the sub-ordinate in order to produce and sustain high standards of performance

To identify vendors/suppliers of laboratory instruments, glassware’s, contract laboratories, & etc., Evaluates the documentation, preparation of comparative sheets, followed by order & purchase related activities of quality control laboratory

Involving & interacting with cross functional team/site/corporate analytical technical team for scope of improvement with respect to process, procedure, technique with developing productive working relationship with colleagues, service engineers and relevant third party professionals

Utilizing analytical knowledge, skills and experience to prepare of Quality control laboratory & other departments SOP’s as per requirements of the company policies & procedures, HSE regulations and cGMP & cGDP requirements

Period: January 2019 – December 2021

Organization: Zentiva Private Limited (Previously known as Sanofi India Ltd),

Ankleshwar, Gujarat, India

Designation: Assistant Manager, Quality Control - API

Delivering support to the QC manager in daily management of QC laboratory

Review of daily calibration of all laboratory instrument/equipments (i.e. Analytical balances, pH meters, KF titrator etc.,), Temperature monitoring log of laboratory areas, Cooling cabinet etc.,

Reviewing of laboratory raw data, calibration documents, analytical reports of chromatogram system & non chromatogram system, assessment of In-process samples, In-process validation samples, PD lab samples, recovered solvents, stability samples, Raw materials, Intermediate, finish products samples, and simultaneously transferring analytical data on SAP, as well as verification on SAP for accurately data transfer, releasing of raw materials through SAP, preparation of stability summary sheet report for stability samples in addition to preparation of manual COA’s accurately in legible writing for finish products.

Undertaking various administrative duties such as handling of laboratory incidence, out of specification (OOS), out of trend (OOT), unplanned deviation, and change control of Quality control laboratory

Conducting laboratory investigation using appropriate investigation tools

Utilizing analytical knowledge, skills and experience to provide appropriate solution of instrument malfunction/errors/handling of instruments as well as troubleshooting of instruments at all times for efficient and effective work

Identifying the laboratory errors and offering viable suggestions for online corrections, Conducting training to the sub-ordinate, in order to produce and sustain high standards of performance, to reduce laboratory errors

Successfully participated at the time of USFDA and other regulatory audits as well as vendor audits

Period: February 2015 – January 2019

Organization: Sun Pharmaceutical Industries Ltd., 4708 GIDC, Ankleshwar, Gujarat,

India.

Designation: Senior Executive, (QMS section) Quality Control – API

Delivering high level of support and assistance to the QC managers & Quality Head in all aspects of daily management of QC laboratory

Responsible for review of daily calibration of all laboratory instrument/equipments (i.e. Analytical balances, pH meters, KF titrator, halogen moisture analyzer etc.,), Temperature monitoring log of laboratory areas, stability chamber’s & Cooling cabinet etc.,

Reviewing of laboratory raw data, technical data, analytical reports of chromatogram system & non chromatogram system, analytical template assessment of In-process samples, In-process validation samples, PD lab samples & Finish products and simultaneously verification on LIMS for accurately data transfer, Perform cleaning sample method validation (By UV) of finish products

Verifying Specification/Analytical test procedure & stability protocols on LIMS, identifying the errors & offering appropriate suggestion for corrections

Handling of working standard, Reference standard, primary/secondary standard, Calibration standard & Impurity standards, maintaining accurate records of respective inward records/discard records & other technical data records of laboratory instrument/equipment (IQ/OQ/PQ/Instrument/Equipment history card)

Undertaking various administrative duties such as handling of change control, out of specification (OOS), out of trend (OOT), out of calibration (OOC), Lab event & unplanned deviation of Quality control Lab & Microbiology Laboratory

Conducting laboratory investigation using appropriate investigation tools (i.e. Fishbone, 5Why, FMEA, Brain Storming etc.,) and ensuring the timely completion of investigation, deriving appropriate correction/corrective action preventive action based upon outcome of the investigation & performing Risk Assessment with Impact Assessment as accordingly. Ensuring any deviation from procedure or policy is reported immediately and appropriate action taken

Involving & interacting with cross functional team/site/corporate analytical technical team for scope of improvement with respect to process, procedure, technique with developing productive working relationship with colleagues, service engineers and relevant third party professionals

Utilizing analytical knowledge, skills and experience to provide appropriate solution of instrument malfunction/errors/handling of instruments as well as troubleshooting of instruments at all times and involving with Quality personnel’s (Wet lab/HPLC/GC section) for efficient and effective work

Identifying the laboratory errors and offering viable suggestions for online corrections

Conducting training based on need of training to the sub-ordinate, in order to reduce unconfirmed OOS, OOT, Lab event & un-planned deviations produce and sustain high standards of performance

Accountable for trending of monthly logs of OOS, OOT, OOC, Lab event & Unplanned deviations and evaluating quarterly, half yearly & yearly trend with the aim of proposing viable solution, deriving appropriate CAPA, Risk/Impact Assessment & adequate implementation of CAPA

Maintaining work areas to the agreed standard of housekeeping, as well as ensure all laboratory work carried out meets the requirements of the company policies and procedures, HSE regulations and cGMP requirements

Successfully faced USFDA, WHO, ISO and other regulatory audits as well as vendor audits

Achievement: Successfully completed Training of “Investigations Technique” conducted by Mr. Shamik Pandit (Trainer, GMP Scientific Co, USA)

Period: Continue - November 2014

Organization: Zydus Cadila, Unit-I, 291, GIDC Industrial Estate, Ankleshwar,

Gujarat, India.

Designation: Executive (Raw Material QC Section In-charge), Quality Control -API

Supporting QC managers and DGM QC to provide an efficient and effective service in all aspects of the daily management of Raw Material QC

Responsible for planning of daily analysis work & raw material sampling activities for QC chemists/Officers/Analyst.

Reviewing of Raw material QC laboratory raw data, technical data, analytical reports of chromatogram system & non chromatogram system, Analytical template assessment of raw materials, Pre-shipment materials, ION materials, solvent storage tank, PD lab samples & finish products and simultaneously documenting all information honestly & correctly transfer on SAP

Undertaking various administrative duties such as documenting of out of specification (OOS), Laboratory event & any deviation from procedure or policy immediately and appropriate action taken, Preparation of manual COA’s accurately in legible writing for Pre-shipments materials, ION (Inter office note) materials & solvent storage tanks along with release of raw materials through SAP, Printing of approved/rejected labels/KSM (Key Starting Material) reserve sample labels through SAP, Maintaining & monitoring of KSM reserve samples & KSM reduce testing samples, updating KSM reserve sample inward register as well as raw material reduce testing logs in a timely manner

Accountable for trending of monthly logs of “daily receive/release tanker”, “daily receive/release raw material”, “Total raw materials (i.e. KSM, non-KSM, Solvent & Pre-shipment samples) receive/release” & coordinating with senior management

To ensure work areas to the agreed standard of housekeeping, in addition to all laboratory work carried out meets the requirements of the company policies, procedures, HSE regulations and cGMP requirements additionally, assure the require training is completed in order to produce and sustain high standards of performance

Successfully faced USFDA, WHO and other regulatory audits as well as vendor audits

Achievement: Received a Silver Coin in recognition of successfully completion of USFDA Audit

Period: November 2010 – October 2012 (Continue to Zydus Cadila, Unit I,

Ankleshwar Plant)

Organization: Zyfine Fine chemicals Ltd, A Division of Zydus Cadila Health Care, Near ACC Cement Plant, Sarkhej Bavla Highway, Changodar, Ahmedabad Gujarat, India.

Designation: Executive, Quality Control - HAPI

To analyse all types of samples such as raw-materials, in-process samples, process validation samples, intermediates, stability samples & finished products using test methods defined in the appropriate specification or protocols, to- the required level of accuracy

To support QC managers to perform Method validation (By HPLC/GC/UV) of Key Starting Materials, Intermediates (if applicable), and Finished Products as well as perform daily and monthly calibration of all laboratory Instruments/Equipments, Undertaking various duties such as monitoring of temperature & humidity data monitor of stability room, & quality control laboratory

To document calibration data records, analytical laboratory data records & other experimental work in a timely manner

Accountable for maintaining & managing of working standards in addition to review of QC laboratory raw data, analytical reports of chromatogram system & non chromatogram system, Analytical template assessment of raw materials, in-process samples, intermediates & finished products in a timely manner

Period: August 2009- November 2010

Organization: Torrent Pharmaceuticals Limited, Near Indrad Village, Taluka: Kadi,

Dist: Mehsana, Gujarat, India.

Designation: Executive (Stability Department), Quality Control - Formulation

To analyse all types of stability batch samples on HPLC and RRLC instruments by using test methods defined in appropriate specification or protocol (e.g., Assay, Related Impurities, Dissolution GF/IF etc.,) to the required level of accuracy, & in compliance with USFDA, WHO and GMP standards

To make sure all laboratory activities are carried out in compliance with Quality and GMP standards

To ensure the required training is completed in order to produce and sustain high standards of performance

To ensure all work carried out meets the requirements of the company policies and procedures, HSE regulations and GMP requirements

To document test results of stability batch samples, honestly & accurately in legible writing in a timely manner

To ensure any deviation from procedure or policy is reported immediately and appropriate action taken

To document OOS, OOT and Laboratory Incident reported immediately and appropriate action taken

Period: February 2009- August 2009

Organization: Lincoln Pharmaceuticals Ltd, 10, 12, 13 Trim Estate, After Vadsar

Village, Nr. Khatraj Chokdi, Kalol, Gandhinagar, Gujarat, India

Designation: Officer, Quality Control – API & Formulation

To test purchased materials, manufactured bulk/intermediate pharmaceuticals or finished medicinal products in compliance with GMP and WHO standards

Actively support the QC manager and QC In-charge to provide an efficient and effective service in all aspects of the daily management of QC laboratory

To support and work within different department such as Raw-Material, IPQC/Finish and Stability

To analyse all types of samples using different test methods defined in appropriate specification or protocol, to the required level of accuracy

To document test results and prepare COA for all finished medicinal products honestly and accurately in legible writing and accurately transfer results on to computer in a timely manner

Undertaking various duties such as performing calibration of all laboratory Instruments/Equipments, & documenting calibration data record sheet

Maintaining & managing of working standard, impurity standard, primary reference standard, calibration standard & primary/secondary standards as well as stability batch samples, oven temperature reports, stability protocols and batch samples testing reports in compliance with Quality and GMP standards

Period: April 2008- November 2008

Organization: Sanofi-Aventis, Rainham Road South, Dagenham, Essex RM 10 7XS

United Kingdom

Designation: Analyst, Quality Control - Formulation

Actively support the QC head and laboratory leaders to provide an efficient and effective service to the PPU’s and their customers

Ensure all laboratory activities are carried out in compliance with Quality and GMP standards

To perform sampling activities of primary packing samples & analyse all types of samples using test methods defined in the appropriate specification or protocol, to the required level of accuracy

To document all information honestly and accurately in legible writing and to accurately transfer results to LIMS in a timely manner

To ensure all work carried out meets the requirements of the company policies and procedures, HSE regulations and GMP requirements

To ensure the required training is completed in order to produce and sustain high standards of performance

To ensure any deviation from procedure or policy is reported immediately and appropriate action taken

To maintain work areas to the agreed standard of housekeeping

To be responsible for the safe and correct use of designated instruments and ensure instrument performance is maintained

To provide support to other team members or other work areas as and when required

Assist when required to drive improvements in product and/or process quality, & Conducting training based on need of training to the sub-ordinate

Period: April 2006- April 2008

Organization: Weston Ltd, 329 Barking Road, Plaistow, E13 8EE London, U.K

Designation: Assistant Manager/Dispensary Assistant/Pharmacy Technician

Delivering a high level of support and assistance to the pharmacist in all aspects of the daily operational management of the pharmacy/dispensary

Accountable for the accurate preparation and dispensing of prescriptions as well as the preparation of special ointments, creams, mixtures and medicine blister packs as per patients need as required

Maximising sales of OTC medicines by identifying customer’s individual medical requirements and offering viable product solutions

Utilising medical knowledge to provide customers with an up to date and accurate medicines information service

Providing consistently high standards of customer service at all times and ensuring the timely resolution to any queries or issues

Developing productive working relationships with colleagues, customers and relevant third party professionals

Performing a number of stock management functions including co-coordinating deliveries and stock takes. Undertaking various administrative duties such as maintaining accurate records and conducting audits

Period: June 2005-April 2006

Organization: Kent Pharmaceuticals Pvt. Ltd, London, U.K

Designation: Analyst (Contract Trainee), Quality Control - Packaging

To support the QC head, & senior analysts to provide a competent and efficient service

Maintaining and Calibration of Laboratory Equipment

To make sure the required training is completed in order to produce and maintain high standards of performance

To analyse all types of packing materials using test methods defined in the appropriate specification or protocol, to the required level of accuracy along with to document analytical laboratory data record sheet

To perform analytical test on Proof Reader, Break Force meter, & Shadow Graph as per Quality Specification

Ensuring implementation of GMP and writing reports according to GMP

ACADEMIC PURSUITS

M.Sc.: Pharmaceutical Sciences, The University of Greenwich, Kent UK (2003-2005)

Specialisation: Pharmaceutical Analysis & Pharmaceutics

Research Project (Involved Analytical Laboratory work) – Comparative Gas Chromatography (GC), Gas Chromatography – Mass Spectroscopy (GC-MS) & High Performance Liquid Chromatography (HPLC) Analyses of Commercial and Synthesised Cinnamic Acids

Pharmaceutical Formulation, Processing, Packaging & Control

Pharmaceutical Analysis & Testing

Mathematics & Statistics

Medicinal Chemistry & Therapeutics

Pharmaceutical Microbiology

Introduction to Biotechnology

B.Sc.: Chemistry (1st Class), South Gujarat University, India (2000-2003)

Organic Chemistry

Inorganic Chemistry

Physical Chemistry

Analytical Chemistry

Petrochemicals

Chemical Analyses

Physics & Mathematics

Diploma: Computer Software & Hardware Engineering (1st Class), National Polytechnic, Gujarat, India (1999-2001)

Achievement: Received a Medal in recognition of 1st Class grade

H.S.C: Science Subjects from G.H.S.B, Gandhinagar, Gujarat, INDIA (2000)

S.S.C: G.S.E.B, Gandhinagar, Gujarat, INDIA (1997)

ADDITIONAL QUALIFICATIONS

December 2006 - Qualified Medicine Counter Assistant, NPA (National Pharmacy Association)

August 2007 Education and Training, London, U.K

August 2007 Qualified Dispensing Technician (NVQ LEVEL 2), NPA (National Pharmacy Association) Education and Training, London, U.K

INTERESTS AND ACTIVITIES

Currently include: Internet, Music, Reading, Outdoor Sports, Yoga, & Socialising with

friends

Area of Work Interest: Quality control Documentation, LIMS, QA of QC, IT of QC, API QC/QA, QMS section, GLP section, QC Administration, Formulation QC/QA

REFERENCES ARE AVAILABLE ON REQUEST

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