1. ABHRA CHANDRA
Passport No-K6662266
UAE Residence Visa No-140265275
Emirates ID: 784-1988-6485493-4
abhrachandra44@gmail.com
Mobile- +971527442286
Add: Al Nahda Sharjah, UAE
Objective
I would like to get associated professionally with an organization where I can devote my
learning towards the growth of the company with responsibility.
Job Profile
Current Organization
LIFEPharma FZE Dubai, UAE, (EU-GMP, GCC, Taiwan FDA, ISO 9001:2008, MOH-UAE,
MOH-Ethiopia, NDA-Uganda, MOH-Kenya, Ivory Cost) from January 2014 to till now as a
Quality Documenter.
A manufacturing unit of Tablets, Capsules, Syrup and Suspension.
Job Description as QA Officer (21/01/2014 to till now)
 Responsible for Vendor Qualification.
(New vendor and Alternative Vendor Development for API, Excipients and Packing material,
Approval of qualified vendor after reviewing of regulatory requirement documents, Updating of
Vendor List and Vendor Qualification Calendar, Preparation of Vendor Audit Schedule, Caution
Note Preparation and Banning of Vendor, controlling of overall process by SAP System).
 Responsible for preparation of Annual Product Quality Review.
(Identification of Critical Process Parameter, Online data entry for process parameters , stage-
wise yield and reconciliation data entry ,Tabulation of in-process and Finished product QC data,
annually graphical presentation for one calendared year and determination of Process capability
by statistical terms.
 Responsible for implementation of SAP System.
Responsible for SOP implementation through SAP, Responsible for implementation of QMS
System through SAP and Providing training to SAP users. Responsible for counter check of
eBMR, process order, inspection plan, and UD.
 Responsible for Internal Audit System.
Preparation of Schedule for Internal Quality Audit and its execution
compliance monitoring. Giving intimation for audit to auditee.
Assigning of auditor for audit and after audit compiling of CAPA
and reports controlling of overall process by SAP System as well as
documentation.
 Responsible for providing Good Documentation Practice and
Basic Quality Assurance related training for new employee.
Provide guidance to existing and new employee for maintaining
Training Card, Training Attendance Sheet, Questionnaires, Preparation of Annual GMP/GLP
calendar and maintain in annual log month wise. Responsible for Providing the training through
SAP System.
 Responsible for preparation and revise of SMF according to implemented changes.

2.  Responsible for preparation of Hold Time Study protocol and Report (Dispensed Material
Tablets and Liquid).
 Responsible for preparation of Transportation Study Protocol.
Preparation of protocol, Analytical data compiling, Photographs compiling, Data logger placing
and data extraction from data logger, compiling of reports.
 Responsible for Preparation of Cleaning Validation Protocol and Reports.
 Responsible for preparation of Risk Assessment and Investigation reports.
 Responsible for preparation of Process validation protocol and Report (Tablets and Liquid)
 Responsible for Document Control.
(Receiving of approved document, Maintaining Master copies in safe custody, issuance of
control copy for internal use and uncontrolled copy for regulatory requirements, destruction of
superseded or obsolete master copy, controlling on issuance of Batch Record [BMR and
BPR],formats, labels and Approved Draft Documents).
 Responsible for Archival, retrieval of Batch Records (BMR, BPR), Log books,
Specifications, STP’s, Artwork, Shade Card, SOP, Protocols and Reports.
 Responsible for preparation of new SOPs as well as revising of existing SOP’s. For
implementation Training and Training Evaluation of the New or Revised SOP.
 Responsible for Evaluation of Batch Records (BMR & BPR) and Analytical Data Sheet along
with COA (as per specification) for releasing the Batch.
 Handling of Deviation, Change control with its post implementation effectiveness verification,
Incidents, CAPA and maintaining its records.
 Responsible for co-ordinate with Regulatory Department for review and submission of
regulatory requirement documents from QA Department.
 Qualification Activity
Handled HVAC System Qualification for new System and Requalification for existing System.
Handled for Requalification of Dispensing and Sampling Booth.
Previous Organization:
Symbiotic Pharmalab(USFDA and EU GMP) Pithampur, Indore, India from
June 2013 to January 2014 as a QA Supervisor.
Job Description as QA Supervisor (20/06/2013 to 08/01/2014)
 Review of Batch manufacturing record (BMR), Batch packing record (BPR), Master cleaning
validation record (MCVR), and Super master cleaning validation record (SMCVR).
 Responsible for Issuance of batch records (BMR and BPR), Log books and formats for execution.
 Responsible for Dispensing activities.
 Maintain daily records (Log Book, Environmental control records, Balance verification records,
Equipment cleaning and usage records and sanitization records etc).
 Sampling of Active pharmaceutical ingredients (composite, finish, stability sampling).
 Report plant status of running batches to our shift in charge.
 Effective implementation of quality system in plant.
 Any additional activities allotted time to time by head of department or his deputy.

3. First Organization:
ESKAG PHARMA Pvt. Ltd.(WHO-GMP) Sidcul, Haridwar, India.as a Trainee QA Chemist.
A mfg.unit of Tablets, Capsules, Ointment, Hormone, Syrup/Suspension & Oral powder
Job Description as QA Chemist (08/10/2012 to 10/06/2013)
 Work as a team member to achieve the target without compromising any Quality Parameter.
 To ensure the visual cleanness & chemical contamination of the residual active ingredients by
means of Swabs/Rinse sampling.
 Inspect and verify equipment and work area cleaning operation.
 Monitor and maintain records for environmental control including Temperature, Relative
humidity, Air handling unit and Water system.
 Maintaining control sample of the finish product.
 Preparation, Issuance and control of BMR & BPR.
 Online In-Process Control & BMR/BPR documentation.
 Preparation of SOPs & their implementation.
 Preparation of annual product review (APR) the batches at the end of the year.
 Preparation of validation protocol.
 Handling deviation and change control and maintaining its records.
 Batch record review as per specification.
 Periodic Inspection and disposal of control samples.
Internship
Worked at “Wockhard Limited, Biotech Park (EOU-Tablet). Aurangabad”,
Maharashtra, under the supervision and guidance of Mr. Jeetesh Singh (Head
of Production) on Process Validation of Ropinirole Hydrochloride 1mg film
coated tablet from 2nd
July to 10th
December 2011.
Audit Appearance
EU-GMP (Poland), WHO-GMP, GCC Audit, MOH Kenya, MOH Audit of UAE, ISO Audit, Abbott
Audit,
Professional Qualification
2012 Completed M. Pharm from Siksha ‘O’ Anusandhan University with
CGPA 8.87
2010 Completed B. Pharma from West Bengal University of Technology with
DGPA7.33
Training and Assignments
2009 Completed Industrial Training at Bengal Chemical and Pharmaceutical Ltd (Production)
2008 Completed Industrial Training at Dey’s Medical (Production)

4. Software and IT
Personal Information
Father’s Name : Mr.Satya Brata Chandra
Father’s occupation : Retired Bank Officer (SBI)
Gender : Male
Marital Status : Married
Nationality : Indian
Passport No. : K6662266
Language Known : English, Hindi & Bengali
Date of Birth : 29th
January 1988
Permanent Address : 21/4 M M Feeder Road, Ariadaha
Kolkata-700057
Present Address : Room No 512, Shahara Medical Center Building, Al Nahda
Sharjah, UAE.
Referees by
Will be provided on request.