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Officer Quality

Location:
Bahadurgarh, Haryana, India
Salary:
6.5 lakh
Posted:
June 26, 2019

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Resume:

Vikas Thakur Mob no:+91-749*******

+91-980*******

Career Objective

To be an essential part of the organization and proving myself as an asset to it, contributing my efforts for achievements & progress of the organization. I am keen to join an energetic professional team.

Professional Qualification

B. Pharmacy in year 2011

Working Experience

1- Current Organization:

Organization : Alkem Laboratories

Designation : Senior Officer Q.A

Department : QA, QMS.

Category : Pharmaceutical QMS,

Place of Posting : Baddi(Himachal Pradesh)

Duration : 11th Feb 2016 to till date

2- Worked with Organization:-

Organization : Mankind Pharma Pvt. Ltd.

Designation : Officer Q.A

Department : IPQA

Category : Pharmaceutical (Formulation)

Place of Posting : Paonta Sahib

Duration : March 2012 To March 2014

Organization : Sun Pharma Industries Ltd.

Designation : Senior Officer Q.A

Department : QA

Category : Pharmaceutical (Formulation)

Place of Posting : Paonta Sahib

Duration : March 2014 To Feb,2016

Job Responsibilities

ALKEM LABORATORIES LTD:

–Handling of self-inspection.

–Preparation and review of QA SOPs.

–Handling of, Change Control, Deviation, Market Complaint,CAPA and

Risk assessment.

–Maintain master SOPs, STPS, specifications, MFR and BOMs.

–Preparation of PQRM (Plant Quality Review meeting) data on monthly basis.

–Maintain distribution and retrieval record of SOPs, STPs, specifications and other QMS documents.

–Follow up for Technology Transfer documents for ANDA’s.

–Procurement of Documents from Other departments for submission to DRA

–Procurement of Documents from Other departments/Sites for site transfer products

Sun Pharma Industries Ltd.

–Preparation and Review of SOPs

–Handling of QMS Software i.e. Trackwise, DCM, LMS

–Handling of SAP for Process related activities

–In Process Quality Assurance

–In Process Testing

–Line Clearance for Batch Manufacturing

–BMR and BPR Review

–Sampling of In process and Finish Product

Mankind Pharma Pvt. Ltd.

–In Process Quality Assurance

–In Process Testing

–Line Clearance for Batch Manufacturing

–BMR and BPR Review

–Sampling of In process and Finish Product

–Investigation of OOS and Deviation

–Investigation of Batch Failure

–Handling of Investigation

Work Exposure

–Successfully handled audit of USFDA, MHRA, ANVISA, TGA, HPRA, WHO and MCC without any major observation.

Achievement

–Played Vital Role in USFDA Audit of Alkem Laboratories.Ltd.

–Implemented Excel Based auto tracking system

Additional Responsibilities

-Reduction of Overdue CAPA,Deviations and Change Control

-Surprise Audit to ensure all time audit readiness

-Internal and External Customer Support

Computer Literacy

MS office and Excell

Personal Traits

−Quality-Leadership, Energetic, Confidence, Interpersonal skill, Coordination skill, mentoring skill, coaching skill.

−Ability to adapt with different cultural and working environment.

−Positive approaches towards all situations.

Linguistic ability

Proficient in English, Hindi

Personal Details

Father’s Name

Marital Status

Permanent Address

Thakur Dass Verma

Married

C/O Mr. Thakur Dass Verma Near Bhaghat Cooperative Bank,

Raboun Solan(H.P)

Declaration: I certify the above-mentioned information is true to the best of my knowledge and nothing has been concealed. I have been always sincere and hardworking and would always work honestly for growth and development of the organization.

Vikas Thakur



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