Kiran Kumar is a senior manager at Aurobindo Pharma with over 16 years of experience in quality assurance. He leads a team that reviews quality control data and provides analytical assurance. Previously, he worked at Mylan Laboratories as manager of quality control assurance, auditing contract manufacturing units. Kiran holds an MSc in Pharmaceutical Chemistry and BS in Botany, Zoology, and Chemistry. He has validated over 210 analytical methods, audited over 100 firms, and faced regulatory inspections from agencies like USFDA.

1. KIRAN KUMAR
MERUSOMAYAJULA
CONTACT INFORMATION:
Phone: +91 8008054382
E-Mail:
kirankmeru@gmail.com
EXPERIENCE:
Total of 16 years in Quality
PRESENT ADDRESS:
H.No :3-6-6/9,
Sai Sadan,
Near Telephone Exchange,
Vivekananda Nagar,
Kukatpally, Hyderabad.
CAREER OBJECTIVE:
A highly motivated, committed and qualified looking for a challenging and
responsible position in Quality with exposure over 15+ years to excel in the field of
pharmaceuticals (API).
COMPETENCIES & STRENGTHS:
 Effective decision making and goal attaining attitude even at Critical times.
 Had audited more than 100 firms.
 More than 210 analytical methods were validated under my supervision.
 Handling of OOS, OOT, Market Complaints and Incidents.
 Handling of internal and regulatory audits.
 Handled process validations, drying validations and cleaning validations.
 Knowledge of cGMP and regulatory requirements of major markets.
 Work effectively with diverse groups of people.
 Ambitious, hardworking and committed to excellence.
 Strong analytical background and expertise in HPLC, GC, Stability and
Method Validations.
 Effective time management for completion of projects by planning with
excellent Team co-ordination and support.
 Key and motivating team player.
 Strong leadership abilities.
JOB PROFILE:
Presently working with Aurobindo Pharma Limited as Senior Manager in
Corporate Quality Assurance. Responsible for Analytical Assurance and Quality
Control Laboratory Compliance across the API units.
ACADEMIC RECORDS:
 Master of Science in Pharmaceutical Chemistry from BITS, Pilani.
 Bachelor of Science in Botany, Zoology and Chemistry (BZC) from Osmania
University.
EXPERIENCE:
S. No ORGANISATION PERIOD DESIGNATION
01
Aurobindo Pharma
Limited
November 2015 to
till date
Sr. Manager - CQA
02
Mylan Laboratories
Limited
November-2013 to
November 2015
Manager - CQA
03
Dr. Reddy’s
Laboratories Limited
March-1999 to
November-2013
Head QC
04
Fleming Laboratories
Limited
October 1998 to
March-1999
Chemist - R&D
RESUME

2. PERSONAL PROFILE:
Name: Kiran Kumar M
Father: Subrahmanya Sarma MSV
Date of Birth: 28th
July 1978
Sex : Male
Nationality : Indian
Marital Status: Married
Children : One
Languages Known to speak and
write:
English, Hindi, Telugu
HOBBIES:
Browsing net,
Watching cricket.
CERTIFICATES/AWARDS:
Received PSAI award at Dr.Reddy’s
laboratories limited for active
participation and timely completion
of a project making customer
delight.
Received training certificate from
Agilent technologies on RRLC
session in Singapore.
CURRENT JOB PROFILE (Aurobindo):
 Leading a team of QC data reviewers, who reviews the data round the
clock.
 Providing analytical assurance for the data generated in QC labs.
 Handling of incidents related to QC data.
 Making QC labs ready for the regulatory inspections anytime.
 Imparting training to the team on Quality topics.
 Supporting the site QC & QA for regulatory audits.
CURRENT JOB PROFILE (Mylan):
 Planning the audit schedules and executing the audits.
 Qualifying Contract Manufacturing Units (CMU) for manufacturing of API
and API intermediates.
 Auditing CMUs and Vendors.
 Evaluation of CMU and Vendors.
 Preparation of audit reports and follow-up of CMUs and vendors for
response with suitable CAPA.
 Conducting trainings to the CMUs on GMP, GLP, and GDP etc...
 Supporting CMUs for regulatory audits.
 Handling of QMS for CMUs.
PREVIOUS JOB PROFILE (DRL):
 Handling of Quality Control Laboratory.
 Supporting Regulatory Affairs for pre DMF review & DMF filings.
 Responsible for Regulatory queries response.
 Handling of Analytical Method Validations and cleaning validation of
analytical methods.
 Pharmacopeial evaluation.
 API Impurity profiles.
 Ready to face the Customer & Regulatory audits with the team members
by motivating apart from the day to day activities at any time.
 Planning and monitoring of analysis of stability studies of finished
products and Holding Time Studies for Intermediates.
 Handling of Change Control.
 Handling of Deviation.
 Handling of OOS, OOT and Incidents.
 Handling of Market Complaint, returned goods and Product Recall.
 Review and approval of departmental SOP’s.
 Review of Process validation Protocols and Reports.
 Conducting Internal Audits.
 Review of APQR.

3. TRAINING PROGRAMS:
ATTENDED:
- ISO 9001-2008 and 19011:2011
Internal Quality Auditors Training.
- Attended 1 day intensive training
on ‘Analytical Method Validations’
organized by USP in 2009.
- Attended various in-house/outside
programs wrt GMP, USP, GLP,
ICH, Regulatory guidelines,
instrumentation etc.
TRAINING PROGRAMS
CONDUCTED:
Trained the peers on…
 Analytical Method validations.
 Data Integrity.
 Analytical Cleaning validation
 HPLC trouble shooting.
 21 CFR requirements and its
compliance.
 Operating HPLC and GC
instruments.
 Impurity profiling.
 ICH Guideline
 Calibration procedures.
 Reference/Working standard
management.
KEY ACHIEVEMENTS:
 Secured distinction in M.Sc. (Tech) with cGPA 9.41
 Had audited more than 100 firms.
 More than 210 analytical methods were validated under my supervision.
 Converted more than 100 manual titration methods into potentiometric
methods and successfully validated them under my supervision.
 Worked on regulatory queries for Omeprazole, Amlodipine, Docetaxel and
Pantoprazole and responded in time and received appreciation from
management.
 Developed fast LC methods by RRLC and reduced the cycle time.
 Faced USFDA, EDQM, MHRA and other regulatory audits.
 Worked for USP verification audit.
 Having hands on experience on sophisticated instruments like HPLC, GC,
UV, IR and KF Titrator and wet analysis.
Place: Hyderabad
(Kiran Kumar)
Date: