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Quality Assurance

Location:
Mumbai, Maharashtra, India
Salary:
10,00000
Posted:
January 18, 2018

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Suhas S. Patil

MOBILE - 981-***-****.

ac322y@r.postjobfree.com

Professional Summary

About 15 years experienced in the field of Pharmaceutical Quality Assurance (Formulation).

Visit to United kingdom at Bristol laboratories limited for technical discussion on Quality matters, Audits, implementation of GLP,solving Data integrity issues.

Assist in Internal and External Quality Systems Audits and the CAPA implementation.

Vendor evaluation and qualification for starting materials, raw & packing materials.

Logging and handling the investigations for Incidence, Deviations & Discrepancy and providing CAPA for the same through QMS Software.

Providing support for OOS & OOT investigation of OOS generated at Corporate & Plant.

Change control management through QMS Software.

Provide support to the various divisions for effective and efficient implementation of the Quality Management System.

Co-ordinate with Production, ADL, warehouse and Maintenance regarding non-conformance corrective action for the same.

Review of Analytical Method Development, Analytical Method Validation, Technology Transfer, Instrument calibration,STP, FPS, MOA’s, BMR, MFR,PVP,PVR, Exhibit COA’S, PDR, USFDA Query response Documents, APQR, Licenses, Process Validation, Cleaning Validation, Equipment Qualifications and other QMS related Documents.

Conducting Vendor audits, preparing Audit report & checking compliance & follow up action for its CAPA.

Looking after data Integrity reviews activities at different sites/locations, performing investigation & providing CAPA.

Handling of product complaints and providing CAPA for the same.

Ability to review analytical method, cleaning and process validations.

Review & Approval of Analyst Qualification, working standard qualification through LIMS software.

Experience of analysis on Bulk drugs, finished products, Packing Materials, in process products, stability products on all sophisticated analytical instruments.

Experience of calibrating all sophisticated analytical instruments/equipment.

Experience of working on all sophisticated analytical instruments like High Pressure Liquid Chromatography, Gas Chromatography, PH-Meter, U.V Spectrophotometer, Polari meter, Dissolution Tester, Karl Fischer, Digital Balances, FTIR, Digital Friability, Hardness Tester,

Disintegration Apparatus, Colorimeter,

Refractive index Tester, DSC Apparatus, etc.

Strengths

Increase in Quantity & Quality of work by effective use of available resources/systems.

Very flexible and adaptable to change/innovations.

Responsible, loyal, disciplined accountable nature & operate with integrity and team work.

Learning attitude and logical approach.

Computer literacy skills in programs that applicable to role, solid written and verbal communication skills.

Ability to independently define problems collects data, establish facts and draw conclusions.

Work Experience

Working with BRILL PHARMA PVT LTD, a subsidiary of BRISTOL LABORATORIES LTD as “Assistant manager ”-Quality Assurance an MHRA, WHO GMP, USFDA, FDA certified company from 17/07/2017 to till date.

Worked with ‘AJANTA PHARMA LTD’ as “Sr.Execeutive”- Quality Assurance an ISO 9001:2008, WHO GMP, USFDA, FDA certified company, from 16/02/2015 to 10/07/2017.

Worked as Executive in Corporate Quality Assurance department with ‘IPCA LABORATORIES LIMITED’ from 19/01/2009 to 07/02/2015.

Worked as “RESEARCH ASSOCIATE”- A.D.L with ‘AJANTA PHARMA LTD’ from 06/05/2008.to 17/01/2009.

Worked as Q.C “CHEMIST” with “BDH INDUSTRIES LTD.” from 21/03/2007 to 30/04/2008.

Worked as Q.C “CHEMIST” with “BEE PHARMO LABS PVT. LTD.” from 17/11/2003 to 20/03/2007.

Job Responsibilities

Reviewing of Analytical Method Development, Analytical Method Validation, Technology Transfer, Instrument calibration, STP, FPS, MOA’s, BMR, MFR,PVP,PVR, Exhibit COA’S, PDR, USFDA Query response Documents, APQR, Licenses, Process Validation, Cleaning Validation, Equipment Qualifications and other QMS related Documents. (Protocols, Report & Supporting Analytical Documents).

Making sure that all deviations, Incidences, discrepancies are investigated and resolved before the release of the dossiers.

Planning & coordinate the internal audits, prepare report & check for compliance & CAPA.

Making sure that the quality related complaints are investigated and resolved.

Checking and approving the PDR’s before submission.

Review and approval of qualification protocols and reports for instruments and equipment’s.

Review and approval of Raw material& Finished product specifications & Calibration records.

Checking and Inspection for GMP related activities in ADL department.

Checking the records for the proper maintenance of environment, safety and health of the working personnel.

Making sure that effective systems are used for maintaining and calibrating critical equipment’s.

Making sure that the Validations are appropriately analyzed and the accurate results are reported.

Making sure that there is stability data update to support retest or expiry dates and storage conditions on release batches.

Inspection of periodically and check on the implementation of Standard Operating Procedures (SOP) during the operation in all Research Centre.

Checking the housekeeping and cleanliness of the work places.

Evaluating the clean room procedures and cleanliness of the working personnel in all departments.

Giving training to the personnel and evaluating the skills.

To assist Manager-QA in compliance of quality systems e.g. change controls, deviations, incidences, customer complaints etc.

To assist Manager-QA and V.P. in continuous systems updation.

Internal audits in the lab for compliance of GLP.

To help in drafting, reviewing and approval of all departments SOP.

Document control and maintenance.

Giving guidance to colleagues for following quality systems.

Preparing/reviewing the internal audit schedules and checklists.

To Prepare & carry out Trend Analysis for Incidents, Deviances, Market complaints.

Vendor and Supplier Qualification & Vendor addition through QMS Software.

To Support for OOS, OOT, Complaints investigation and rootcauses identification.

Review of analytical documents to checks the authenticity & integrity.

Education

Master of Science in Chemistry from Viniyaka Mission University, India in Year-2011.

Bachelor of Science in Chemistry, From Mumbai University, India in Year-2003.

HSC from Maharashtra Board in Year-1999.

SSC from Maharashtra Board in Year-1997.

Technical Skills

Food Drug & Administration (FDA) approved in Chemical and Instrumentation section

Attended seminars on Trouble shooting on HPLC techniques, Vendor audits for API & Packing Materials.

Computing Skills

Diploma in Office Automation (Microsoft Office, Coral Draw, Photoshop, etc.)

Diploma in Hardware Engineering. (Assembling, Installation, Troubleshooting, Maintenance.)

Personal Details

Date of Birth: 29th March1981.

Address: 104/J Ganesh Prasad Niwas, 1st Floor, Room No-8, Near Vijay Mitra Mandal, Worli Koliwada,Mumbai-400 030.

Languages known: English, Hindi, Marathi.

Hobbies: Reading, Singing & Listening Music, working on Computers,

Playing & watching cricket.

Marital Status: Married.



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