KHUSHBU GUPTA

Contact No.:970-***-****

E-mail: acd46k@r.postjobfree.com, acd46k@r.postjobfree.com

To be a part of prestigious organization where I can utilize technical and

conceptual skill inherent in me and build a career by my commitment and

dedication to work.

Around 7 years of Experience in Pharmaceuticals Industry, in Production and

Corporate Quality Assurance.

Comprehensively Familiar pharmaceutical productions-packaging activities,

GMP process and Quality Systems.

Completed Bachelor of Pharmacy and Diploma in Drug Regulatory Affairs,

having professional experience in the fields of Manufacturing and Packaging

Operations of Non-Sterile Oral Solid Dosage Forms & knowledge in cGMP and

Quality Systems.

Bachelors of Pharmacy from Shri Govindram Seksaria Institute of Science

and Technology, Indore in the year 2006 with 68%.

Diploma in Drug Regulatory Affairs from IPER Institute of PUNE in 2009.

Pursuing Executive MBA from ITM Hyderabad.

IPCA LABORATORIES LTD., Mumbai, (May-2012 to April-2013)

Executive CQA.

Preparation of SOPs and Corporate Quality Guidelines.

Handling of deviations, Change Control and Incidents for all locations.

Worked in System Design team to Implement TrackWise for eQMS.

Participated in multiple audits for different manufacturing plants.

Preparation of MIS reports.

Mentored junior team members.

RANBAXY LABORATORIES PVT. LTD., DEWAS, (May-2006 to April 2012)

Documentation Executive.

Performed activities like Qualification, Validation and preparation of

SOPs.

Handling of Change control, Deviations, Investigations and Market

Complaints of the block.

Participated in External and Internal Audits.

Worked as a team for giving audit responses.

Worked as Departmental Training Coordinator and Trainer.

Actively participated for implementation of new electronic software like

DCM, LMS, Trackwise.

Have good exposure in eQMS.

Production Executive

Worked as Production supervisor in Cephalosporin block.

Exposure in handling packing equipment.

Performed Calibration of equipments like - Checkweigher, Hygrometer,

Manometer, Weighing Balance.

Quality Systems :

Preparation of SOPs and Corporate Quality Guidelines.

Handling of Deviations and Change control.

Experience of performing internal and external audit as part of CQA team.

Handling of Market Complaints.

Preparation of Site Master File and Block Manual.

Imparting training.

Qualification :

Qualification of Manufacturing Equipment: Blender, RMG, FBD, Compression

machine, Coater etc.

Qualification of Packaging equipment: Blister and Strip packing machines

Others : LAFs, Area Qualification and brief exposure in HVAC and Water

System Qualification

Validation :

Familiar with Process and Cleaning Validation Documentation

Production Operations :

Batch monitoring during Manufacturing and Packaging operations

BMR & BPR Review

SOP Preparation

In-Process checks

Training and Development :

Worked with LMS for E learning programs and imparted training to

departmental personnel.

Worked as Departmental Training Coordinator in Block-C.

Preparation of departmental training matrix, Job description, Traininer

Qualification log etc.

Generation of curriculum and training classes.

Imparting training of SOP's and guidelines.

Others :

Participation in regulatory audits like USFDA, EU, ANVISA, TGA, MHRA, MCC

and WHO

Sending of Responses to audit observations

Documentation representative for Cephalosporin Block

LMS (Learning Management System) - It is 21CFR based software meant for

managing online training related activities of an individual.

DCM (Documentum Compliance Manager) - It is 21 CFR based software meant for

preparation, compliance and electronic signature of Standard Operating

Procedures (SOP).

Trackwise System- This is an online system for preparation,

approval/rejection and tracking for change control, deviations, OOS, OOT,

market complaints

Working Knowledge of SAP, SCM, DMS.

Software known:- MS -office, MS-word, and PowerPoint, Internet

Installation of New Dry Syrup Line.

Successful completion of Project "HARMONIZATION".

Successful completion of Project "CROSS CONTAMINATION".

Qualification of complete block due to major shut down for preparation of

the same for regulatory audits.

Completion of Project "Block - C at a glance".

Result-oriented.

Hard working

Mr. Rajendra Dadhich,

Vice President- Quality Assurance, Ipca Laboratories Ltd., Mumbai

Mob no. 098*******

Mr. Vikash Chavda,

Scientist F R&D generics IPDO,

Dr. Reddy's, Bachupalli, Hyderabad

Mob no. 099*******

Mr. Kailash Joshi,

General Manager - Production, Mylan Lab., Nasik

Mob. No.098********

Address for Communication: - Nihar Agrawal,

Block - B, Flat no. 303,

Aparna Heights, near Chirac Public School,

Kondapur, Hyderabad

Date of Birth : - 28th Nov 1984

Marital Status : - Married

Husband's Name : - Mr. Nihar Agrawal

I hereby declare that all the information stated above is true to my

knowledge and belief.

KHUSHBU GUPTA

CAREER SUMMARY

OBJECTIVE

EDUCATIONAL QUALIFICATIONS

WORK EXPERIENCE

COMPUTER PROFICIENCY

ACHIEVEMENTS

STTENGTHS

REFERENCES

PERSONAL PROFILE

DETAILED AREAS OF EXPOSURE

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