1. Kalyani Kadam
sunkal91@yahoo.com mailto:sunkal91@yahoo.com
mailto: kalyanisandeepkadam@gmail.com
Personal Details:
Residential address -B/8, Avantika Society, Gavanpada Village Road,
Mulund (East) Mumbai 400 081, India.
Telephone no. - +91-022-25632282.
Marital status - Married.
DOB – August 27th, 1978.
Mobile: 9833116557.
Education / Awards
 Bachelor’s Degree in Microbiology (Wilson College), University of Mumbai,
India, 1998 (Second Grade)
 Diploma in Nutrition & Food Technology, S.N.D.T. University, Mumbai.
 F.D.A. approval in ‘Microbiology & Sterility’ from Maharashtra State in 2003.
Other Professional Attainments
• Certificate of participation in Laboratory Quality System Management & Internal
Audit based on ISO/IEC - 17025 organized by International School of
Laboratories.
• Actively participated in Co-operative Education Program organized during April-May
1997 by Wilson College, Mumbai, wherein I did placement at Rashtriya Chemicals
& Fertilizers Ltd (RCF), Mumbai.

2. Career Profile
Span Biotronics Private Ltd. July-2014 - Till
Date
Designation: Application Specialist
Span Biotronics is an instrument R&D division of Span diagnostics. I was currently
involved in development of semi-automatic biochemistry analyzer. I was responsible to
provide inputs regarding addition of new features and ideas to the developed
biochemistry analyzers as per customer feedback. I was also responsible for product
verification and validation including functional software testing. Responsibility involves
training to colleagues and customers and technical support to Product Management
Team.
Rubicon Research Private Ltd. Oct-2013 - June-2014
Designation: Project Manager
Rubicon Research is a pioneer Drug Delivery Technology company in India and is
recognized as a world class outsourcing partner in pharmaceutical industry. Rubicon
provide complete spectrum of services in the drug development program for our global
partners consisting of formulation development, analytical development, stability
evaluations and technology transfer. My job responsibilities involve tracking projects,
making project status review sheets for director's review. I am responsible for preparing
minutes of telecon meetings with clients, on discussing updates about the client's
projects. I am responsible for finalizing the material budget prepared for each phases and
get it approved by client. I work in co-ordination with business development team. After
receiving a new project various activities right from allocating resources, providing
timelines for the same are few examples that I handle.
IRIS Healthcare Pvt. Ltd April2012 –Sept 2013
Designation: Assistant Product Manager
IRIS (Innovative Reagents Instruments & Services): IRIS is the service providing company
in Healthcare sector. I was responsible for the work related to all the product lines
(reagents, instruments and external quality assurance – EQA). Reagents of international
quality i.e. Dialab from Hungary was one of the biochemistry product range for which I
also performed application role as well w.r.t. biochemistry analytes. I handled EQA
(external quality assurance program) of RCPA (Royal College of Pathologist of
Australasia). IRIS is the only RCPA EQA program provider comprising of all disciplines in
Pathology. I took care of customer queries related to RCPA and guided in reviewing of
the EQA report and even gave the interpretation of the results and the corrective action
provided for the outliers if any. Provided the guidance on calibration requirements if any

3. bias observed or to look for IQC (Internal Quality Control) results if any imprecision
being observed.
Rubicon Research Pvt Ltd Feb 2011 – March 2012
Designation: Microbiologist
Following were the job responsibilities: I was responsible for day-to-day functioning of
lab in connection with analytical work in microbiology department. I was heading the
department with a team of 3 associates. Analysis of raw materials, inprocess, finished
products was performed. Also environment monitoring of the area, preservative
effectiveness testing (of Johnson & Johnson) and any other clientele project work has
been performed.
SRL Ranbaxy Ltd April 2008 – May 2009
Designation: Assistant Manager - Quality Assurance
Following were the job responsibilities:
• Monitor accessioning of Proficiency testing programs such as Biorad- MCC, MIA,
Biweekly CC, Randox Hematology, CAP proficiency, AIIMS, CMCH, ILQA etc.
• Follow up with section & PT Result reporting and reviewing: online Biorad –
MCC, MIA, Biweekly CC also online CAP, manual – AIIMS, IAMM, CMCH.
• Reviewing assessment and outlier e-mails: Biorad – MCC, MIA, Biweekly CC,
Randox Hematology, CAP – downloading assessment and completing self
evaluation.
• CAP Assessment – follow up for corrective action with the section within
stipulated time.
• Manage and Monitor maintenance of PT data in various files.
• Preparation of Zone-wise Monthly EQAS report in the given format.
• Enrolment in various PT programs from time to time and also renewal of
enrolment.
NPIL Laboratories & Diagnostics Pvt. Ltd July 2005 – March 2008
Designation: Quality Assurance Executive
NPIL was a chain of Path-lab & Diagnostics. I was responsible for maintaining Quality
through various Accreditation program. I was involved in documentation as per ISO:
15189. Responsible for documentation of CAP accreditation for which I have undergone

4. training from a consultant. I was responsible for documentation of Pathology, Molecular
Pathology and Histopathology Standard Operating Procedures. I have undergone the
training in all the departments viz; Pathology, Molecular Pathology, and Histopathology.
I handle the quality control for the Pathology department by plotting Levy Jenings chart
using Westgard’s multirule evaluation for QC run.
Also QA has planned to conduct External Quality Assessment Program (EQAP) for our
labs throughout the country. The disciplines included are Biochemistry, Haematology,
Immunology (T3, T4, TSH), Histopathology & Cytology. Biochemistry & Immunology has
already started.
Ashco Analytical Services, Mumbai, India December 1999-June 2005
Designation: Microbiologist
Ashco Analytical Services is a network of laboratories at various part of India. In the
modern days of pharmaceutical/chemical sciences, the role of instrumental, chemical &
microbiological analysis is highly significant. All the analytical work is carried out as per
the Quality System Requirements meticulously. SOP’s have been made to cover all areas
of operation including receipt, registration, testing, reporting of results.
I was responsible for day-to-day functioning of lab in connection with analytical work.
Responsibilities involved were:
• Microbiological analysis of API & Finished products as per IP, EP, BP, USP or
customers specification.
• Preparation of media & maintaining records for the same.
• Sample analysis & recording the observation & interpretation of results.
• Sub-culturing of microorganisms & maintaining the records.
• Purity -check of the sub-cultured microorganisms.
• In-house calibration for equipments in the microbiological area as per SOP.
• Maintaining records related to Microbiological & Sterility Environment count,
Fumigation record, Burning of U.V. lamp, Waste disposal record, Temperature
record Manometer reading etc.
• Maintaining records for Pharma Control Samples and ensuring proper sample
disposal.
• Also have hands on sophisticated instruments like HPLC (Shimadzu) & GC (Neon).
Cadbury India Limited, Thane September - December 1999
Designation: Trainee Microbiologist

5. During the internship period, I got through exposure at Analytical Methods, Process
Control, Microbiology, Packaging lab and the other in-plant operations.
Taj Air Caterers, Sahara Airlines June - August 1999
Designation: Trainee Microbiologist
Undergone training in Microbiological Analysis of food & water during internship in
Microbiology laboratory.

6. During the internship period, I got through exposure at Analytical Methods, Process
Control, Microbiology, Packaging lab and the other in-plant operations.
Taj Air Caterers, Sahara Airlines June - August 1999
Designation: Trainee Microbiologist
Undergone training in Microbiological Analysis of food & water during internship in
Microbiology laboratory.