Abhinav Bhardwaj
Summary
To pursue a challenging professional career, which involves people management, in an industry where I can put my knowledge, experience and values to the benefit of the organization's and my own growth. My professional objective is to work with a dynamic organization that stimulates me to give my best and be recognized for the same.
My Total work experience is 10 years and six months.
Overview
16
16
years of professional experience
Work History
Deputy Manager Quality Assurance
Pharmaffiliates Analytics and Synthetics, PASL
Panchkula
12.2017 - Current
- Preparation ,Issuance and review of Test Data Sheets
- Preparation , Issuance and review of QMS Documentation like SOP, Protocols etc
- Monitoring of Change Control, Deviations and CAPA system
- NMR interpretation and Review
- Structural elucidation Report
- Review of daily/monthly verification and calibration of equipments
- Evaluation of testing records for compliance and final release of test reports
- Review of analytical data, Certificate of Analysis,HPLC ,IR ,Mass NMR and TGA
- Co-ordination with research and Development team
- Review of R n D synthesis data
- Handling Market Complaints
- Internal Audits of labs
- Handling customer Audits
- Responsible for compliance in accordance to NABL ISO 17025 & U.S.F.D.A
- Audit Exposure: Successfully faced USP Audit and NABL (ISO 17025) Audits twice
- Certifications and Training :NABL-ISO 17025 :2017 certified for QMS audit Lab compliance .
Executive
Mankind Pharma Ltd
10.2016 - 12.2017
- Getting products from every division of Mankind tested from Out- Lab
- Updation of every product status on SAP software
- Reviewing of Certificate of Analysis and the specifications of the products
- Checking test reports of all the products analysed by out- lab
- Maintaining status track of the entire product
- Reviewing Standard Test Procedures of all up- coming new products
- Reviewing bills against the products analyzed
- Controlling Restricted-Unrestricted products, and their release on SAP, for Dispatch to the market
- Analysis of Raw materials, in- process, Reaction monitoring &Analysis of Finish
- Product & Stability Samples
- Preparation of COA, Stability Monthly Schedule, Summary Report and other documentation
- Data Validation & Review
- Regulatory Updates: Coordinating with R.A
- About updates in guidelines
- Organoleptic evaluation and approval of New Products and Shifted Products
- Inspection and Internal Audit of Testing Lab
- Coordination with various units for STP and analysis related requirements.
QA Executive
Torrent Pharmaceuticals, Baddi, HP
09.2015 - 10.2016
- In Process checks during manufacturing and packing of tablets & capsules
- Line clearance
- Batch record reviewing
- Sampling at different stages of manufacturing
- Handling Change Control, CAPA and Deviations
- Cleaning validation
- Acceptable Quality Level
- Control Samples and Stability samples Inspection
- SOP writing and reviewing.
Kemwell Biopharma Pvt. Ltd, Banglore, KemwellBiopharma Pvt. Ltd
09.2011 - 10.2012
- Voted India’s best contract manufacturing organization, the facility is approved by EMA, USFDA
- ANVISA, TGA and Health Canada
- Worked as Jr
- Executive - In Process Quality Assurance in the ‘Oral Solids Unit’ of, Profile-
- In Process checks during manufacturing and packing of tablets & capsules
- Line clearance
- Batch recordreviewing
- Sampling at different stages of manufacturing
- Handling Change Control, CAPA and Deviations
- Cleaning validation
- Acceptable Quality Level
- Control Samples and Stability samples Inspection
- SOP writing and reviewing.
Ranbaxy Labs Private Limited Paonta Sahib
09.2009 - 09.2010
- Worked in manufacturing unit as ApprenticeProduction Officer
- Worked with product development lab (PDL) for carrying out validation of various batches of new products
- Experience in systems, applications and products in data processing (SAP).
Education
M.Pharma - Pharmaceutics
KURUKSHETRA UNIVERSITY
08-2015
B Pharmacy -
M.M. College of Pharmacy, Kurukshetra University
01.2009
12th -
C.B.S.E
02.2004
10th -
C.B.S.E
02.2002
Skills
- QMS ,NMR interpretation Review
- Computer knowledge:Chem draw , Sci finder,Microsoft Office, Basic computer skills
- Hobbies: Passionate about cricket, listening music
Interests
Extracurricular Activities , Played for school cricket team for inter-school cricket matches. Was a Player of Karnataka Institute of Cricket (KIOC) (Karnataka State Affiliated Club)
Languages
Personal details
Date of Birth: 05 May 1986
Marital status: Married
Father's Name: Late Dr Ramesh Bhardwaj
Mother's Name: Late Mrs Sanyog Bhardwaj
Timeline
Deputy Manager Quality Assurance
Pharmaffiliates Analytics and Synthetics, PASL
12.2017 - Current
Executive
Mankind Pharma Ltd
10.2016 - 12.2017
QA Executive
Torrent Pharmaceuticals, Baddi, HP
09.2015 - 10.2016
Kemwell Biopharma Pvt. Ltd, Banglore, KemwellBiopharma Pvt. Ltd
09.2011 - 10.2012
Ranbaxy Labs Private Limited Paonta Sahib
09.2009 - 09.2010
M.Pharma - Pharmaceutics
KURUKSHETRA UNIVERSITY
B Pharmacy -
M.M. College of Pharmacy, Kurukshetra University
12th -
C.B.S.E
10th -
C.B.S.E