1. RESUME
Ashwani Bhardwaj
____________________________________________________________________________________
Address:
House No. 154, Mamta Enclave
Dhakoli, Zirakpur, S.A.S. Nagar (Mohali)
Punjab
Mobile: +91-9592903619
E-mail: ashwanibhardwaj23@gmail.com
____________________________________________________________________________________
CAREER FOCUS
To develop, grow professionally, contribute and share responsibility in development and research in
your esteemed firm.
PROFESSIONAL SUMMARY
 Well versed with CGMP requirements & Quality Assurance activities of Pharmaceutical
industry.
 USFDA, EDQM, KFDA, TGA and WHO (Geneva) agencies audits handled and auditing experience
to vendors/manufacturing sites/labs/contract labs.
 Practical experience of preparation of QA documents (Master Manufacturing Records/STP,
Annual Product Reviews, risk assessment for occurrence/change in system/procedure, change
control/deviation form, audit report, internal/external audit response, SOPs, Qualification of
instrument/equipment/system/facility/utility, Validation of process/methods, Preparation of
Protocols/Reports).
 Working with multi departments. Interface; internal - (DRA, Supply chain, Marketing, Various
internal location’s Quality and production department) external – Contract Manufacturers.
 Practical knowledge of SAP (System, applications and product in data processing). Active user
of SAP management team.
 Responsible for monitoring and maintaining quality and compliance targets with the assurance
of products comply with legislation and quality assurance code.
TOTAL EXPERIENCE – 9 years [M/s Sun Pharmaceuticals, erstwhile known as Ranbaxy labs ltd
(Mohali), M/s Panacea biotec ltd (Mohali) and M/s Bajaj Healthcare ltd (Thane, Mumbai)]
• Presently working with M/s Bajaj Healthcare Ltd, Thane (Mumbai) as a Asst. Manager QA
(API) (04th
July 2016)
 Handling of team for QA activities, monitoring of progress, helping them to resolve query,
giving decision in day to day activity.
 Direct contact for handling external audits and ensure compliance to the audit observations
within the agreed time lines.
 To upgrade quality assurance system and procedure of contract locations to meet cGMP
requirement by implementation of Standard operating procedure and training to personnel

2. • 07th
December 2015 – 25th
June 2016 with M/s Panacea Biotech , Punjab as a Asst. Manager
QA (API)
JOB RESPONSIBILITIES
 To effectively plan and execute the technology transfer from Research and Development (R&D)
to existing manufacturing sites or contract manufacturing sites in compliance with regulatory
requirement.
 To effectively plan, co-ordinate and perform the technology transfer associated with New
Chemical Entities (NCEs), Active Pharmaceutical Ingredients (APIs) and Intermediates from the
following stages: the earliest phase in a products/ process life cycle, pilot scale-up,
commercialization and post-approval transfers.
 To identify, approve and renew the Quality Agreements related to contract manufacturing and
contract testing facilities.
 To perform audit around contract manufacturing facilities, prepare the list of audit findings and
check the compliance status in-line with the ICH-Q7A [International Conference on
Harmonization] guideline.
 To review and ensure the completeness as well as the effectiveness of all the corrective and
preventive actions (CAPA) raised by the contract manufacturing facility for adequacy and
accuracy.
 To co-ordinate with the analytical research development laboratory for technology transfer of
analytical methods from developing and validating laboratories in R&D to Quality Control
laboratories.
 To create the vendor pre-qualification dossiers includes sample approval procedure, TSE/BSE
(Transmissible Spongiform Encephalopathy / Bovine Spongiform Encephalopathy) declaration
from vendors, non-disclosure certificates, vendor audit reports and vendor evaluation
questionnaire in co-ordination with Commercial department.
 To assess the vendor performance for quality improvement for the suppliers of raw materials,
key starting materials, intermediates and packaging materials.
 To initiate quality risk management process includes risk identification, risk analysis and risk
evaluation based on current knowledge about assessing the probability, severity and detect-
ability of the risk in NCEs, APIs manufacturing facilities.
 To co-ordinate with the cross-functional team, which includes projects, production, process
development laboratory, analytical laboratories for introducing the new product/new process
in the existing manufacturing or contract manufacturing facility
• 01st
September 2007 – 04-Dec-2015 with M/s Sun Pharmaceutical Industries Ltd (Erstwhile
Ranbaxy), Mohali, Punjab as a Executive QA API
JOB RESPONSIBILITIES
 Handling of team for QA activities, monitoring of progress, helping them to resolve query,
giving decision in day to day activity and report to seniors routinely.
 To evaluate the new sites for the capabilities to meet ICH Q7 and other regulatory requirement
for manufacturing of starting material, APIs and drug Products.

3.  To plan, get execute and review new product manufacturing plans, tech transfer, exhibits
batches, commercial product release, stability, retest programs and submission of data to DRA.
 To prepare, get approval and ensure implementation of Quality Agreements at contract
locations.
 To upgrade quality assurance system and procedure of contract locations to meet cGMP
requirement by implementation of Standard operating procedure and training to personnel.
 To evaluate deviations, change controls for impact on quality and approval.
 To conduct and monitor periodic audits at contract manufacturing locations. Periodic review
the performance of Contract Manufacturing locations for all time readiness for external audits.
 To facilitate the conduct of internal, external audits and ensure compliance to the audit
observations within the agreed time lines.
 To evaluate and monitor the risk factors/gaps with mitigation plans; review quality failures,
market complaints, implementing action plans for quality improvement and tracking CAPA.
 To ensure response for the regulatory queries from the contract manufacturing sites and
shares the commitments with sites for information and compliance.
 Review of various qualification/validations (utility qualification, analytical method validation,
cleaning process validation, Process validation, drying validation, blending validation, facility
qualification, Lab instrument qualification, process equipment qualification, , computer
qualification attached to lab instruments etc.) Site master file and Annual product review.
 To resolve analytical variations between the supplier, user testing labs and problems during
analysis.
 To impart training to the personnel at contract manufacturing locations for the identified topics
of cGMP.
 Possess knowledge on laboratories instruments such as HPLC, GC, FTIR, UV
spectrophotometers etc.
Core Competencies
Knowledge of QA systems Stability Study Management Awareness of compliance tools
SAP knowledge 21 CFR part 11 requirements Performing Audits
Facing Regulatory Audits Data review for RA filing
ACADEMIC QUALIFICATION
Masters in Science (Chemistry)
B.Sc. - Non Medical, Panjab University, Chandigarh, INDIA
Approved Analyst from drug control department of Punjab, India
PERSONAL PROFILE
Father’s name : Sh. R. D. Bhardwaj
Date of Birth : 22-03-1983
Nationality : Indian
Status : Married
Languages known : English, Punjabi and Hindi
Hobbies : Reading, collecting valuable information through
Internet, Listening Music

4. Current CTC : 8 Lac per annum
SALARY EXPECTED : Negotiable