CURRICULUM VITAE

VAIBHAV KUMAR

Total Exposure: 12.0 Years

Permanent Address :

Flat .No -918,2nd floor, Imperial Estate,

Opposite - Heritage Apartments, Peermushalla,

Punjab - 140603

E-Mail : ac8d2s@r.postjobfree.com

Contact No.

+974-********

Career Interest :

Validation (Cleaning, Process & Hold Time study

Qualification

(Equipment/ Utility)

QMS System

Quality Risk Management

Audit & Compliance

Project Involvement:

Project completed at the targeted time for Europe market

Personal Competencies :

Have Good Level of Persuasiveness.

Good Communication, Drafting and evolution Skills

Excellent team driving skills

Eagerness to learn new systems & procedures

Language Skills:

English

Hindi

Strength :

Positive thinking

Hard working

Honesty

Simplicity

Interests :

Travelling

Cricket

Badminton

CAREER OBJECTIVE

To work in an atmosphere where I can translate my Quality assurance skills and innovative energies into action in the Quality Assurance and contribute in attaining the organizational objectives.

PROFESSIONAL QUALIFICATION

M.Pharm from Shobhit University, Meerut (India) in the year 2009 with 7.30 CGPA.

B.Pharm from U.P. Technical University, Lucknow (India) in the year 2005 with 61%.

PROFESSIONAL WORK EXPERIENCE

CURRENT WORK EXPERIENCE:

Presently working with M/s. Qatar Life Pharma, Doha (Qatar) as a Team Leader in Quality Assurance (Compliance) since August 2018 to till date.

PREVIOUS WORK EXPERIENCE:

Worked with M/s. Torrent Pharmaceutical limited, Baddi (HP) as an Executive in Quality Assurance since July 2012 to August 2018.

Worked with M/s Unichem Laboratories Limited Baddi (HP) as a Quality assurance Officer since May 2010 to June 2012.

Worked with M/s Indswift Laboratories Limited Derabassi (Punjab) as a Quality assurance Officer since Sep. 2009 to May 2010.

Worked with M/s Glenmark Ltd., Baddi (H.P.) as a Jr. Q.A. officer since June 2006- Sep. 2007.

Worked with M/s Alembic Ltd., Baddi (H.P.) as a Trainee Q.A. officer since June 2005- June 2006.

TOTAL WORK EXPERIENCE: 12.0 Years

CURRENT JOB RESPONSIBILITIES:

Leading a Team of Quality Assurance department at Qatar Life Pharma, Doha (Qatar). Responsible for the compliance of the entire activity of IPQA and Documentation.

Compliance & Handling of IPQA Activities:

Leading the entire team of IPQA officer and Responsible for the in process quality assurance for Tablet, Liquid, Semisolid & antiseptic. Taking responsibility of all IPQA activity for the plant approved by MOH-Qatar. Giving the solution for day to day IPQA observation. Responsible to keep plant always in the compliant mode.

Validations & Qualification Activities:

Assessment, Review and handling of validations (Process, Cleaning & Hold Time Study) and Qualification (Equipment &Utility) activities. Preparation and Review of Validation & Qualification protocol and its report. Preparation and Review of hold time protocol and its report.

Technology transfer of Products:

Review all the activities for smooth transfer of products from R & D to site. Smooth execution of exhibit/validation batches at the site for the submission to MOH-Qatar.

QMS System (Change Controls & Deviations):

Evaluation, impact assessment, Monitoring and controlling of the changes & Deviation by implementing the change control system and Deviation System through Trackwise as per cGMP regulations. Route cause analysis and effective implementation of the system by proposing corrective, preventive actions to rectify the recurrence.

Quality risk management:

Actively involved in all quality risk assessment exercise. Responsible for review of quality risk assessments.

Master recipe:

Responsible for Review, Archival, Issuance and uploading of Master Recipe of Equipments

Self inspection:

Self inspection done for all the departments. Follow up for the compliance of the observations during self inspection. Review and closer of self inspection report.

Regulatory submissions:

Reviewing and submission of the documents protocol and repots of the validation batches, BMR & BPR to RA for Filing in MOH-Qatar.

Audit Compliance Report:

Handling and preparation for suitable response for the audit observations during for all the audits. Implementation of corrective measure in coordination with other departments.

SOP’s:

Preparation of Master SOP’s as per c-GMP & Review of inter and intra departmental SOP’s.

cGMP standards:

Implementing the cGMP practices in the manufacturing facility by introducing current good manufacturing practices & by conducting trainings.

Activities handled during Audit.:

Escorted auditors to the production area explaining the process and procedure.

Explained batch manufacturing and batch packing records to the auditors.

Explained validation & qualification protocol / hold time study protocol and reports to the auditors.

AUDIT EXPOSURE:

Successfully faced MOH-QATAR audit at Qatar Life Pharma, Doha (Qatar).

Successfully faced EU-GMP, AVVISA, TGA and various regulatory and customer audits at Torrent Pharmaceutical Limited Baddi.

Successfully faced MHRA, AVVISA, TGA and various regulatory and customer audits at Unichem Labs. Limited Baddi.

Successfully faced USFDA, MHRA, AVVISA, TGA and various regulatory and customer audits at Glenmark Pharmaceutical Limited Baddi.

AUTOMATED SOFTWARE HANDLED

Trackwise software for Change Control, Deviation, Investigation & CAPA

TMS (Training Management System) for Training of SOP’s.

SAP

PERSONAL DETAILS

Date of Birth 01-01-1984

Marital Status Married

Category General

Nationality Indian

Passport No. S5936897

The information furnished here is true to the best of my knowledge and believe.

Place :

Date :

(VAIBHAV KUMAR)

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