Curriculum vita

Satish Karta
Contact Information:  satanu2007@rediffmail.com,  +91-8884111436
SUBJECT

CV for suitable position in Quality Assurance Department

SUMMARY
As a pharmaceutical professional in Generic Pharmaceutical Industry with 14+ years of experience in various
organizations such as M/s Neuland, Cipla, Dr.Reddys, Biocon , BiOZEEN and Cipla. I have been successful in
contributing new ideas, building and motivating teams in various organizations. Presently working as deputy
manager in analytical QA in Cipla.

PROFICIENCY

 Quality Control, Quality Assurance, Technology Transfer (API)( synthetic and semi synthetic drugs),
Sterile Filter Validation and Extractable-Leachable on CCS
 GAP Analysis, Analytical Method Validation, Data Governance, SOP’s, and Risk Assessment, QMS,
Resource management and Team Management.

AUDIT EXPOSURE
 USFDA, MHRA, Regulatory CGMP Audits

EDUCATION

 M.Sc. Microbiology (2000-2002), Bharathidasan University, Trichy, Tamilnadu, India.

 M.Sc. Ecology & Environment (2002-2004), Sikkim Manipal University, Distance Education.
 B.Sc. Chemistry (1997-2000), Andhra University, Visakhapatnam, Andhra Pradesh, India.

WORK EXPERIENCE-KEY AREAS

 Sterile Filter Validation, Extractable and Leachable studies on Container Closure System
 Interactions with Customers within India and Third Party Laboratories
 Team and Work Management to meet the customer requirements
 API Technology Transfer (Method Qualification, Method Transfer, Vendor Evaluation to Final API)
 Method Validation, Method Transfer, Calibration and Stability Reports Review and Approvals
 Non-Routine Validation (Water, Nitrogen Gas Validation)
 Exposure to USFDA, cGMP, TGA & MHRA Audits.
 Evaluation of Change control for Exhibit batches
 Raw materials sampling, Calibration of QC Analytical Instruments like HPLC, UV, IR, Water etc.,
 Method Validations ,Forced Degradation and Photo Stability Studies
 Microbiology activities – Analysis of API samples, Water Samples, Stability Samples (Micro Analysis)
 Environmental monitoring studies in microbiology lab and production blocks
 Participated in Audits – FDA, MHRA and Customer Audits

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 Curriculum vita
 Bacterial Endo-Toxin Test (GEL Clot Method)
 Raw material Analysis in QC
 Calibration of analytical and microbiology related equipments
 Preparation of trend plots for water and API data.
 Handling HPLC, GC, IR and U.V. Spectroscopy.

ROLES AND RESPONSIBILITIES

Current organization: CIPLA AUG 2017 to TILL DATE

Designation: Dy. Manager Lab QA

Review of Non conformances (OOS, OOT, Analytical incidences)

Handling of release management and review process using SAP, LIMS software’s

Preparation of trend plots for water, API data and non conformance trends.

Monitoring daily Laboratory Activities includes Progress of Team Members, Progress of Sample Analysis,
Review of Protocols, Reports.

Review of MV, MT and calibration reports and working STD qualifications reports.

Review of microbiology reports.

Ensuring Retention of documents and destruction of records.

Ensuring daily reconciliation for all instruments.

Issuance the formats as per need to QC team members.

PREVIOUS ORGANIZATION 5. BIOZEEN MARCH 2016 to JULY 2017

Designation: Lead –validation Technology

Biozeen is an ISO 9001:2008 Certified consulting and delivery of high end services including automation and
validation services for equipments and processes. From concept design to commissioning to validation and
beyond covering every aspect of a project including complete responsibility for critical process equipments
offering complete Design Build Solutions of high-end Bioprocess equipments for customers world wide

 Review of Sterile Filter Validation documents (Injectable Products) like filter train optimization study,
Bubble point, Compatibility Test, Bacterial Retention Test, Extractable Study on Filter Membrane
 Extractable and Leachable study on Container Closure System
 Customer Visits within India to present technical expertise on Biozeen’s Sterile Filter Validation Services
and Extractable & Leachable studies on Container Closure System
 Interaction with customers to collect additional requirements
 Interaction with Third Party Laboratories to fulfill Biozeen Customers requirements.

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 Curriculum vita
 Monitoring daily Laboratory Activities includes Progress of Team Members, Progress of Sample
Analysis, Review of Protocols, Reports, Updating status to Senior Management thus – achieving
Customer satisfaction with Quality and Timely deliverables.
 Evaluation and Addressing Change controls, Deviations and OOS

PREVIOUS ORGANIZATION: 4.Biocon APRIL 2012 TO MARCH 2016

Designation: Assistant Manger – Quality Assurance (Dosage forms)

 Technology transfer (API) – Vendor Evaluation, Stage wise monitoring like Raw materials, Reaction
Monitoring Stages, Intermediate and Final API
 Establish specifications for new drug substances, drug products, review of specifications, test
procedures, batch manufacturing records and validation reports, etc.
 Evaluation of Change controls, Deviations and Lab OOS.
 Evaluation of Stability studies as per ICH-Guidelines
 Familiar with review of method qualification and Method transfer documents
 Involvement in various day to day QA activities to implement up to date knowledge with regard to
guidelines and regulations.
 Contributed in regulatory cGMP audits at manufacturing locations
 Submission of required data to Regulatory Affairs department for dossier filing’s for various regulatory
agencies.

PREVIOUS ORGANIZATION: 3.DR.REDDYS LABORATORIES LIMITED: JANUARY 2009 TO APRIL 2012

Designation: Junior Manager – Quality Assurance (Dosage forms)

KEY RESPONSIBILITIES:

 Review of analytical method development and method qualification reports

 Review of analytical method transfer protocols and Reports form R&D to QC at different stages (RM/IP/FP)
for tablets and capsules.
 Review of stability and Forced degradation reports.
 Review of different packing study reports during development.
 Review of process optimization reports (POR)
 Review of technical reports (exhibit batches Vs validation batches)
 Technical review and approval of TTD, TTD Amendments and IOM’s
 Familiarity with Validation Master Plan, and Validation Protocols in line with c-GMP and Regulatory
requirements.
 Submission of required data to Regulatory Affairs department for dossier filing’s for various regulatory
agencies.
 Responsible for key validations i.e. Process validation, Water system, HVAC and etc.
 Review of Calibration reports for all analytical equipments.

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 Curriculum vita
 Establish specifications for new drug substances and drug products and review of specifications, test
procedures, batch manufacturing records and validation reports, etc.
 Evaluation of Change controls, deviations and Lab OOS.
 Evaluation of Stability studies as per ICH-Guidelines
 Involvement in various day to day QA activities to implement up to date knowledge with regard to
guidelines and regulations.
 Contributed in regulatory cGMP audits at manufacturing locations
 Implementation & Establishment of the Quality Management System

PREVIOUS ORGANIZATION: 2.CIPLA LIMITED: JANUARY 2006 TO DECEMBER 2008

Position: Quality Control (API’s & Dosage forms) –Management staff.

 Responsible for carry out Analytical method validations for HPLC, GC

 Responsible for carry out calibrations for analytical instruments
 Monitoring Stability studies for API
 Preparation of SOP’s, Specifications, COA’S, Method of Analysis and Validation protocols
 Calibration of quality control related equipments
 Qualification of working standards
 Carry out Water system validations
 Coordinating with QA team during key validation programs
 Ensuring the implementation of GLP in Quality Control.

PREVIOUS ORGANIZATION: 1. NEULAND LABORATORIES LIMITED: JANUARY 2004 TO JANUARY 2006

Position: Quality Control (API’S) - Microbiologist/ Chemist.

 Microbiological analysis of water, raw materials and API’s

 Evaluation of Bacterial Endo-toxin test’s for API’s
 Carry out Environmental monitoring in Clean rooms
 Conducted Water system validations
 Monitoring of Retention / Control samples
 Calibration of analytical and microbiology related equipments
 Preparation of trend plots for water and API data.
 Sampling and testing of raw materials, in-process, intermediates and API’s.
 Handling HPLC, GC, IR and U.V. Spectroscopy.
 Testing of Stability samples.

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 Curriculum vita

PERSONAL PROFILE

Name : Satish Karta

Father’s Name : Pitchaih Karta
Date of Birth : June 6th, 1979
Gender : Male
Marital Status : Married
Nationality : Indian
Languages Known : English, Telugu, Hindi and Kannada

Permanent Address : Satish Karta, Flat No 202, 3rd floor

Heritage Heaven #25,

18th main, Narayana Gouda layout, Tavarekere,

Bangalore -560 029.

Phone 8884111436 /9611586586

Referances :

Ch. Suresh Kumar

AGM - Regulatory affairs

Racks pharma

Viazg, Andhra Pradesh

Phone Number: 9246622085

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