QA Manager Document Control
Resume:
RESUME
Ashok Singh Chauhan
Email:
adrds4@r.postjobfree.com
adrds4@r.postjobfree.com
Contact No. 878*******, 997-***-****
Personal Data:
Date of Birth : 21
st
Sep.1975
Sex : Male
Nationality : Indian
Marital Status: Married
Present Address:
B-6, Shri Hari Tenament,
Near Santoshimata Temple,
Panchvati, Gorwa,
Vadodara –390 016 (Gujarat)
Experience:
Indiana Chem Port
349, GIDC Estate Makarpura, Vadodara.
Position: QA Manager
Vovants laboratories Pvt. Ltd.
Opp. Ranoli Railway Station, Ranoli,
Vadodara.
Position: Assit. QC Manager
Bajaj Healthcare Ltd.
Block No.588, Savli Karchia Road
Gothada Tal. Savli Vadodara.
Position: QA/QC Manager
Summary:
Having 22+ years experience of QA/QC in Formulation, Bulk Drug, Intermediate, Speciality & Fine Chemicals.
To control the overall activity of QA/QC Dept.
To Implement and monitor the GMP/GLP System.
To prepare, review and implement the standard operating procedure. (SOP).
Maintaining ISO, GMP, WHO documentation.
ISO, FDA, WHO, GMP, USFDA and EDQM audit faced.
Handling customer, FDA, WHO, GMP, third party and Vendor Audit.
Prepare and review of BMR.
CAPA, Change Control, Deviation, Customer Complaint.
Vendor Audit and Internal audit.
Analyzing the Incidents / OOS in the plants.
Fulfill the regulatory documents requirements.
Review and updating Site Master File, Quality Manual, Layout, Validation Master Plan.
Operation & trouble shooting knowledge of HPLC, GC, FTIR, Spectrophotometer, AAS, ICP-OES.
Calibration & Validation of instruments.
Method Validation.
Process Validation.
Stability Study.
To review and implement the validation protocol and report.
Review and approve analytical report of raw material, In- process, finished product & packing material.
Support to juniors for all kind of testing (In process, raw materials testing, finished product testing.)
Training of Employee, Document Control, Annual
Product Quality Review.
PAB Organics Pvt. Ltd.
101-103 GIDC Nandesari Vadodara.
Position: QA Manager
Bajaj Healthcare Ltd.
Block No.588, Savli Karchia Road Gothada
Tal. Savli Vadodara.
Position: QC Officer
Ethicare Pharmaceuticals (P) Ltd.
307, GIDC, Por, Vadodara.
Position: QC Chemist
Dinesh Pharmaceuticals (P) Ltd.
GIDC, Nandesari Vadodara.
Position: QC Chemist
Education:
B.Sc. Chemistry
University: MDS University Ajmer
Percentage: 63 %
Period : 1996
Assets:
Dynamic analytical and logical skills.
Very positive attitude and result oriented.
Highly motivated & experienced to work & lead a team.
Open to new technologies & applying it.
Flexible & Quick learner.
Strong interpersonal & negotiation skills.
Language Known(Speak, Read, Write):
Hindi, English, Gujarati
Current job profile:
Organization : Indiana Chem Port.
349, GIDC Estate Makarpura, Vadodara.
Designation : QA/QC Manager.
Period : 16
th
Mar 2015 to continue.
Product : API, Non-API and Fine Chemicals
Responsibilities:
To control the overall activity of QA/QC Department.
To ensure Current Good Manufacturing Practices (cGMP).
Self-inspection audits at plant, to ensure compliance to lay down systems.
To ensure that appropriate in-process Controls/ Online checking is being performed during manufacturing and packaging operations.
To ensure online documentation of various manufacturing and packaging operations.
Investigation of various market complaints received and to ensure compliance to the corrective actions mentioned in art of specifications Investigation.
Analyzing the Incidents / OOS in the plants and resolving them scientifically and logically.
To ensure that quality system, process and procedure are in compliance with all regulatory requirements.
To review and track the product related Deviations and Change Controls so as to evaluate nonimpact of it on validated processes and regulatory filing.
To ensure that Raw Material (RM), Packing Material (PM), In-process Goods, Finished product
(FP) is being tested as per approved Standard Testing Procedures (STP) and are released.
To review of the batch records. Review of testing records & COAs.
Co-ordinate & ensure availability of current versions of Batch Manufacturing Records (BMR)/ Standard Testing Procedures (STP)/ Specs & for preparation of APR.
To ensure testing of stability samples is being done as per approved protocol/ Standard Testing Procedures (STP).
To review the stability test reports and highlight the problems observed to the Management.
To ensure that Equipments & Processes employed in the manufacturing /Testing are qualified and validated.
To review Qualification/Validation reports & participate in validation activity whenever necessary lead validation team.
Review and updating Site Master File, Quality Manual, Layout, Validation Master Plan, Process validation protocol, Process validation report, Batch Manufacturing Record, Corrective and Preventive Action (CAPA), Investigation of customer complaint and other incident related to quality. Review of compliance report to be submitted to regulatory authority.
Monitoring of the yields and losses at all critical stages. Summary of previous job profile:
Organization : Vovantis Laboratories Pvt. Ltd.
Opp. Ranoli Railway Station, Ranoli, Vadodara.
Designation : Assit. Q.C. Manager.
Period : 20
th
Mar 2014 to 15
th
Mar 2015.
Product : Formulation (Effervescent Tab)
Responsibilities:
Responsible for analysis of Raw material, In-process, finished products and stability Samples.
Preparation, Standardization & storage of volumetric solution.
Responsible for providing training to trainee officer for analysis.
Working and implementing GLP standards in the laboratory.
Standardization and storage of the working standard and Reference standard.
To prepare the certificate of analysis as per customer's requirement before dispatch of Finished Product.
Preparation of Worksheet, SOPs and STPs for departmental use.
Review of Analytical reports and calibration reports.
To Keep co-ordination with Production and outside Labs for timely release of Materials.
Method validation of new products.
Handling Change control, Incident, Deviation, OOS and Preparation of documents related to QC/QA.
To Handle Process Validation, Cleaning Validation, Protocols Organization : Bajaj Healthcare Ltd.
Manjusar, Savli, Vadodara.
Designation : QA/QC Manager.
Period : 11
th
Mar 2013 to 7
th
Mar 2014
Product : Formulation (Tab, Capsule)
Responsibilities:
To Control the overall activity of Quality control department.
Evaluating and approving change control/deviation for the specification and test method.
Training to Employee for on job training SOPs and Quality management system, GMPs, WHO standards.
Responsible for corrective and preventive action for customer complaint & other Non compliances, deviations and out of specification (OOS).
Prepare annual product review and statistical trend analysis for the data.
Assit in Handling customer, FDA, WHO, GMP, third party and Vendor Audit.
Ensuring quality standards for all incoming material.
Internal Auditing of each department as per schedule.
Ensuring Quality of products as per specification.
To review the stability protocol.
Handling Change control, Incident, Deviation, OOS and Preparation of documents related to QC/QA.
To implement and monitor the GMP/GLP system.
To review and implement the standard operating procedure.
To ensure that all activity complies as per SOP.
To ensure that all the instrument calibrate as per the calibration plan.
To establish and revise the new specification as per the regulatory & as per the pharmacopeias.
Review and approved analytical report of raw material & packing material.
To review and check the finished product analytical report.
To review and approve working standard records.
Organization : PAB Organics Pvt. Ltd.
101-103, GIDC, Nandesari, Vadodara.
Designation : Q.A. Manager.
Period : 1
st
Oct 2009 to 11
st
Mar 2013.
Product : Pharma Intermediates.
Responsibilities:
To Control the overall activity of Quality Assurance department.
To implement and monitor the GMP/GLP system.
To review and implement the standard operating procedure.
To ensure that all activity complies as per SOP.
To ensure that all the instrument calibrate as per the calibration plan.
To continuous update training needs identification and on job training, GMP and other related training programs.
To monitor the ongoing stability as per schedules.
To establish and revise the new specification as per the regulatory & as per the pharmacopeias.
To validate the analytical procedure as per ICH guideline.
To review and implement the validation protocol and report.
To co ordinate the production people for planning of dispatch activity.
Review and approved analytical report of raw material & packing material.
To review and check the finished product analytical report.
To review and approve working standard records.
To establish the analytical developments of new product. Organization : Bajaj Healthcare Ltd.
Gothada, Savli, Vadodara.
Designation : Q.C. Officer.
Period : 6
th
May 2007 to 18
th
Sep 2009
Product : Bulk Drugs (API)
Responsibilities:
Testing of finished products like Vitamin ‘C’, Chlorhexidine base, Chlorhexidinegluconate solution, Choline bitartrat, choline dihydrogen citrate, sod. Saccharin, carbamezapine, Chlorhexidine hydrochloride, R&D samples etc.
Calibration of GC, HPLC, Spectrophotometer & other lab instruments.
Finished goods sampling and analysis.
Raw materials sampling analysis.
Method validation on HPLC and GC.
Preparation of finished product and raw materials specification and protocols.
Preparation of volumetric solution protocols.
Preparation of calibration protocols.
Residual solvent analysis and validation.
Support to juniors for all kind of testing (In process, raw materials, finished product testing.) Organization : Ethicare Pharma (P) Ltd.
GIDC, Por, Vadodara.
Designation : Q.C. Chemist.
Period : 1
st
Jun 2001 to 6
th
May 2007
Product : Formulation (Tab, Capsule and Liquid)
Responsibilities:
Raw material sampling as per SOP.
Raw materials testing as per IP, BP., USP and in house specifications.
Finished product sampling and testing.
Finished Product (Tab, Cap, and Liquid) testing as per IP, BP, USP and in house methods.
Analytical method validation.
Preparation of sop and specification of raw materials & finished product.
Stability studies.
ISO, GMP documentation.
Preparation of volumetric solution and maintain its record.
Instruments calibration and validation.
Retain sample observation and testing.
Organization : Dinesh Pharma (P) Ltd.
GIDC, Nandesari, Vadodara
Designation : Q.C. Chemist.
Period : 15
th
Jun 1999 to 31
st
May 2001
Product : Bulk Drug (Paracetamol, Diphenhydramine.HCL) Responsibility:
Raw materials sampling and testing.
Raw materials like Caustic Soda Lye, Sulphuric acid, PNCB, Acetic Acid, Acetic anhydride, Iron testing.
In process intermediates like PNP, PAP, Crud paracetamol sampling and testing.
Volumetric solutions preparation and standardization.
Finish product -Paracetamol, DPH.HCL testing as per IP. INSTRUMENT KNOWLEDGE:
Having operational and calibration knowledge of HPLC, GC-HS, FTIR, Spectrophotometer, Dissolution Apparatus, Karl Fischer, Polarimeter, Potentiometer, Balance, pH Meter, Oven, Stability Chamber, IR Moisture Balance, ICP-OES, AAS. Current salary per annum (CTC) : 7.0 Lac/Year
Expected salary per annum (CTC): Rise as per company rule. Notice Period : 1 Month
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