RAJESH BHASKAR POTDAR

Pharmaceutical Quality Consultant

CORE COMPETENCIES
Overall Quality Control Functions
Analytical Research and
Development
Quality Management System
Implementation
USFDA, MHRA, TGA Regulatory
Inspections
ANDA Project Execution
IRCA Certified Lead Auditor
Regulatory Compliances
Team Leader
Coordination and Communication
Trainer
GAP Assessment and Remediation
pharmaquality.services@gmail.com ; rajesh.potdar@yahoo.com
+91-9819250043 Office: Suhrud CHS, Opp. Risk Care Hospital, Makhmali
Talao, Thane (West), Maharashtra – 400601
PROFILE SUMMARY
About 23 years’ experience in pharmaceutical industry with good technical
knowledge of Pharmaceutical Quality, regulatory compliance. Capable of handling
innovation as well as trouble shooting with good basic analytical ability, creative
and a proactive problem-solving approach.
Practical experience of setting up Analytical facilities with high level of compliance
as per various regulatory requirements like USFDA, MHRA, TGA, ROW etc.
Presently working as a consultant for Quality remediation for data integrity, setting
up compliance w.r.t. system, procedure, QMS and software in various organizations.
Also working on the NDA and ANDA projects with respect to their analytical
development, validation and filing requirements as per various regulatory
submissions.
My experience also Include,
Quality System Implementation/ Laboratory compliance; Established High
level of Laboratory compliance by implementing various quality management
systems and procedures. Handling of OOS, OOT, CAPA, Deviations etc.
Expertise in Stability management program to support operational and
technical aspects of commercial drug substance, drug product, reference
standard, and placebo.
Instrument Qualification, Audit Trails and CSV activities; Handling
Instrument qualification activities, Audit Trail and Computer system Validation
as per GAMP and regulatory requirements
Expertise in Laboratory sample management, sample workflow, scheduling
of sample for testing.
Execution of ANDA projects: Development and Validation of Analytical
Methods, Multimedia Dissolutions, Process challenges, Handling of Deficiencies
Handling of Regulatory Inspections: Faced independently and successfully USFDA,
MHRA, TGA and other regulatory inspections.
Certifications: NSF International’s CQI/IRCA- Quality Management Systems
(QMS) certified Lead Auditor based on ISO 13485:2016 and international
Medical Device Single Audit Plan (MDSAP) requirements

CAREER TIMELINE
Raptakos Brett Actavis (Watson) Emcure Pharmaceutical
Test Pharma Pvt. Ltd., Pharmaceuticals, Quality
Laboratories, Mumbai as Sr. Pune, Maharashtra
consultant
Thane as Quality Manager as DGM (Head-QC)
Control Chemist (Group Leader)

May’97 – Jul’98 Aug’98 – Feb’03 Feb’03 – Sep’14 Sep’14 – Jun’15 Jul’15 – May’16 Jun’16- Jun’18 Jun’18- Till date

Alembic
Cipla Ltd. Pharmaceuticals, Marksans
Patalganga, Vadodara, Gujarat Pharmaceuticals,
Maharashtra as as AGM Goa as DGM
Quality Control
(Site Head-QC) (Head QC)
Officer

1
 CURRENT PROFILE

June 2018 – Till date working as Consultant-Quality, Pharmaceutical Industries

Providing consultancy services in
cGMP/cGLP Documentation
Quality Management Systems
Guidance for Regulatory Audits
Data Integrity Management
QC laboratory Setup
GAP Analysis / Audits/Vendor Audits
Method Development and validation
NDA/ANDA/dossier filing requirements-Analytical part.
Response to Deficiencies and Audit observations
Trainings

PREVIOUS ORGANISATIONAL EXPERIENCE

June 2016 – June 2018 with Marksans Pharmaceuticals, Goa
Deputy General Manager – Head Quality Control
Highlights:
Headed the Quality Control Department
Successful USFDA, MHRA, TGA inspections
Maintained lab in cGMP compliance status
Control and documentation procedures as per regulatory requirements
QMS investigation, OOS, OOT, deviations, product complaints, analytical errors, chromatographic errors
Identification of relevant quality related training needs and conducting training
Stability and Analytical sample Management program and Scheduling of samples
Review of performance data and trend charts against set parameters
Resource management
Focused on laboratory efficiency by modifications in the procedures
Vendor audit and compliance

July 2015 - May 2016 with Emcure Pharmaceuticals - Solid Oral Dosage Unit, Pune, Maharashtra
Deputy General Manager – Head Quality Control
Highlights:
Headed the Quality Control Department with more than 100 numbers of staff
Prepared lab readiness for USDFA Inspection
Maintained lab in cGMP compliance status
Successful MHRA inspection

September 2014 - June 2015 with Alembic Pharmaceuticals (Formulation Unit), Vadodara, Gujarat
Assistant General Manager - Head Quality Control
Highlights:
Headed the Quality Control Department with more than 165 numbers of staff
Independently faced USFDA audit and other regulatory inspections as a department head and successful in these
inspections without any observations
Made improvement in existing GLP procedures and implemented newer automated quality systems in the lab
Reached financial targets set by the management for each quarters
Maintained lab in cGMP compliance status
Stability and Analytical sample Management program and Scheduling of samples
Made improvement in the areas such as writing and timely completion of Investigation, OOS, OOT, Deviations,
product complaints, analytical errors, chromatographic errors, etc.
Effective reporting compliance to the audit points of the customers and regulatory authorities
Worked on, to utilizing the available resources effectively
Achieved financial targets set by the management for each Quarters

2
 February 2003 – September 2014 with Actavis (Watson) Pharma Pvt. Ltd., Mumbai as Sr. Manager Group Leader

Highlights:
From 2008 - 2014 - Analytical Research and Development:
Administrated all ANDA projects related analytical activities considering the requirements of various international
markets
Mentored an analytical team of 18 members
Analytical Method development, validation and transfer to the commercial sites.
Force Degradation studies to determine the degradation pathway
Design, evaluation and monitoring of stability studies of R&D and Exhibit batches
Effective and timely communication with the internal and external customers
Initial set up of laboratory
Before 2008 - QC related activities:
Managed quality control functions for commercial and non-commercial activities
Lead the implementation of quality systems in the lab during its initial set up and got the lab qualified as per MHRA and
US FDA requirements
Set up of laboratory procedures
QMS like OOS, Deviations, Investigations, Change control, Software validations, Compliant handling etc.
Interdepartmental coordination to facilitate the production activities
Interaction with different vendors/ manufacturers of instruments and equipment to know the latest techniques and
implementation wherever necessary
Identification of the needs and to provide resources needed for effective and efficient functioning of the department.
August 1998 - February 2003 with Cipla Ltd., Patalganga, Maharashtra as Quality Control Officer
Highlights:
Gained experience of successfully working in various regulatory audits like USFDA, IMB, MCC South Africa, MHRA UK &
WHO
Analytical Method Validation.
Standard management
Instrument Qualifications and Calibrations
Analysis of Various samples by different analytical techniques
May 1997 - July 1998 with Raptakos Brett Test Laboratories, Thane as Quality Control Chemist
Highlights:
Gained experience on analysis of samples on various analytical techniques
Instrument Qualifications and Calibrations
October 1996 - February 1997 with RPG Life Sciences, Thane as In-plant trainee
Highlights:
Received trainings on various sophisticated analytical instruments and analytical techniques
Undertook & successfully completed In-plant Training and Project on analytical and industrial training

ACADEMIC DETAILS
B.Sc. from Mumbai University in 1995
Diploma in Technical and Analytical Chemistry from Mumbai University in 1997
CERTIFICATIONS/APPROVALS
NSF International’s CQI/IRCA- Quality Management Systems (QMS) certified Lead Auditor based on ISO 13485:2016 and
international Medical Device Single Audit Plan (MDSAP) requirements
Approved by FDA in Chemical Analysis and Instrumentations

PERSONAL DETAILS
Date of Birth: 14th April, 1974
Languages Known: : Marathi, Hindi, and English