Quality Assurance Manager

DEVENDRA SRIVASTAVA

Mobile : 980*******,985******* E-Mail: *******@**********.***

Seeking assignments in QA with a growth oriented organization

PROFESSIONAL SYNOPSIS

A dynamic professional with more than 11 years of Quality Assurance experience in Tablet, Injectable and Liquid formulation plant.

1Current Assignment with M/s. Sun pharmaceutical limited Guwahati as senior executive -QA.

ORGANISATIONAL EXPERIENCE

April 2009- Oct 2016 INTAS PHARMACEUTICAL SIKKIM as Asst. Manager - Quality Assurance

JULY.2006 –MAR ’2009 In IND SWIFT LIMITED,BADDI as Executive - Quality Assurance

CORE COMPETENCIES

Handling Of Data Control Systems:

On Line Documentation Of Various Data Control System Pertaining To Routine cGMP Practices. Viz. Change Control Proposals, Deviation Proposals, and Process Non Conformances Etc.

Preparation And Control Of SOPs:

Preparation, Training, Review, Implementation and Control of Standard Operating Procedures Pertaining To Various Quality Assurance Job And Data Control Systems.

Auditing Of Batch Processing Documents:

Auditing Of Batch Processing Documents (Batch Manufacturing Record And Batch Packaging Records) Before Final Dispatch And Sale, And Reviewing For Any Deviation from Established Procedures And Practices. Preparation Of Batch Release Note After Confirming Batch Processing Documents And Analytical Data For Completeness.

Handling Of Market Complaint:

Receipt of Complaint, Acknowledgement to the Complaint, Investigation

Regarding the Concerned Failure, Coordination with the Respective Department

for future, Corrective Action and Preventive Action (CAPA), Providing Training to

Workmen for Avoidance of such failure in future, setting a tentative Date

of Compliance, Reporting to Head – Quality Assurance Regarding the Findings, And

Their Documentation, and sending Complete Investigation Report to the complainant.

Process Validation:

Preparation Of Process Validation Protocol, Monitoring various stages of Process Validation Exercises being carried out at shop floor, Identification Of Critical Process Parameters, Documentation of various Observed Parameters, Validation Sampling And Analytical Data Review, Preparation of Validation summary report.

PREPARATION OF BMR/BPR

Preparation of BMR as per tech transfer document. Preparation of BPR .

Equipment Qualification:

Monitoring Various Stages Of Equipment Qualification, Coordination With The Engineering Department In Development Of Qualification Protocols, Assisting In Conducting Of Training Session To Workmen Regarding Operation Of Any New Equipment. Preparation Of IQ, OQ

And PQ Documents For Equipments And Requalification. Identification And Preparation Of Calibration Schedule Of Critical Instruments. Tracking The Calibration Schedule For All Equipment / Instruments. Risk assessment of Packing machine

Training:

Conducting Training Session during Induction of New Joining, Creating Awareness Regarding Various cGMP Aspects, Regarding Non-Conformance of Various Market Complaints, In Context With Incidents Etc., Conducting Various Workshops Regarding Correct On Line Filling Of Batch Processing Documents. Conducting Routine cGMP (21 CFR) Training, Training On Respective Revised SOP.

Activity Related To Performance Qualification of Utilities

To coordinate in various activities like HVAC and Compressed Air Performance Qualification Activity and review the documents pertaining to them.

ACTIVITY RELATED TO SAP SYSTEM

Preparation of Hold time study protocol

PERSONAL DETAILS

Name : Devendra Srivastava

Father’s Name : Sh.K.D Srivastava

Date of Birth : 15th April 1979

Marital Status : Married

Sex : Male

Nationality : Indian

Language Known : English, Hindi

DECLARATION:

I hereby declare that the above information furnished by me is true to the best of my knowledge and belief.

DATE: PLAEC: (Devendra Srivastava)

Contact this candidate