Ashok Kotha is applying for a job with the recipient's organization. He has a M.Pharmacy in Quality Assurance from J.S.S College of Pharmacy and is currently a Senior Executive in Quality Assurance at Syngene International Ltd. He has experience with USFDA audits, client audits, quality management systems, and ensuring compliance with regulations. He provides his resume detailing his education, experience handling audits and ensuring compliance, technical skills with software and documentation, and personal details.

1. 1
COVERING LETTER
Ashok Kotha
#S-1 Prabhavathi paramount,
Kammasandra road,
Huskur gate,
Electronic city,
Bangalore – 560100.
Respected Sir/Madam,
This is reference to job applying in your esteemed organization. I, Ashok Kotha, Completed
M. Pharmacy (Quality Assurance) from J.S.S College of Pharmacy, J.S.S University, Mysore.
Currently working as a Senior Executive in Quality Assurance from 02 May 2013 till date.
I guarantee high quality work delivered on or before the deadline and perform all the tasks and
assignments in the best way as a part of improving myself. I do believe that my knowledge and skills
would be a valuable asset to your organization and ready to allocate anywhere.
I would appreciate personal interview at earlier convenience. I look forward to hearing from you.
Thank you for your time and consideration.
Yours sincerely,
Ashok Kotha,

2. 2
CURRICULUM VITTAE
Ashok Kotha M.Pharmacy (Quality Assurance)
Senior executive, Quality Assurance
Syngene international limited,
Biocon Bangalore, Karnataka.
E-Mail: Ashok.kotha999@gmail.com.
Mobile: 07829696686.
OBJECTIVE
 To employ my knowledge and experience with the intention of securing a professional career
with opportunity for challenges and career advancement, while gaining knowledge of new skills
and expertise.
PROFESSIONAL EXPERIENCE & RESPONSIBILITIES
 Organization: Syngene International Ltd. A Biocon company, Bangalore.
 Duration: May 2013 to till date.
 Position: Senior Executive in Quality Assurance.
 USFDA audit: Successfully faced for two times in Syngene International Ltd. with zero FDA 483.
 Client audits: Faced more than 30 client audits with effective CAPA implementation.
 Knowledge in Quality Management System (QMS).
 Knowledge in USFDA and ICH Harmonized guidelines.
JOB DESCRIPTION
 Responsible for Preparation, Issuance and review of Batch Records, Master Records,
Standard Operating Procedures.
 Handling of Change control and ensuring CAPA closure for deviations as part of Syngene job
responsibilities.
 Handling of Change Controls, Deviations, OOS and Market complaints.
 Responsible for preparation and review of Process validation, cleaning validation Protocols
and Reports.
 Preparation, review and approval of cleaning verification reports.
 Responsible for preparation of quality metrics as part of QMR by quarterly basis.
 Preparation of Annual product review Protocol and Report.
 Label Control, Storage and Reconciliation.
 Finished product Dispatch.
 Preparation of Internal Audit Plan, Training Plan & Coordinating with other Departments
 Preparation and review of weekly and monthly reports.
 cGMP Rounds in the manufacturing area.
 Preparation of response (Compliance Report) to various regulatory and customer audit
observations.

3. 3
 Effectively handled audits from various regulatory authorities which includes but not limited
to:
 USFDA US Food and Drug Administration.
 QP Audits Quality Person Audits.
 Various Client Audits (BMS, AMGEN, ABBOT, NOVARTIS,DRL & AJINOMOTO)
EDUCATION
Masters of Pharmacy
(Pharmaceutical Quality Assurance)
2011-2013
JSS COLLEGE OF PHARMACY,
Mysore
76.00%
Bachelors of Pharmacy 2007-2011
Talla Padmavathi College of
Pharmacy ,KU, Warangal,
India
71.00%
Class XI-XII
(Board of Intermediate Education, AP)
2004-2006
K.N.R Junior College, Andra-
pradesh, India
87.00%
Class X 2003-2004
Vidya Niketan High School,
Warangal, India
79.00%
TRAININGS
 Nine months training at Anglo French Drugs & Industries Ltd (Bangalore)
 Conducted various training program on good Documentation practices at Syngene
International Limited, Bangalore
M.PHARM PROJECT TITLE
“CLEANING VALIDATION OF NITRAZEPAM TABLETS”
ACHIEVEMENTS and POSTER PRESENTATIONS
 Awarded “Certificate of Appreciation – Spot Recognition” from Syngene for effective support
and resolving queries of our client – ABBOT.
 Presented paper on “PROCESS ANALYTICAL TECHNOLOGY-CURRENT SCENARIO” in
international level seminar at khatmandu university Feb-2012
 Presented paper on “COMPARATIVE STUDY OF IN-PROCESS AND FINISHED PRODUCTS
QUALITY CONTROL TEST OF IP, BP & USP FOR PARENTRALS” in 63st IPC held at Bangalore.
 Attended for workshop on “Emerging trends, challenges and future perspectives in
Dissolution testing” organized by JSS college of pharmacy, Mysore, 24th – 25th January, 2012
TECHNICAL SKILLS
 Software package: MS Office (Word, Excel, Power Point).
 Well versed with internet browsing, other office tools and software.

4. 4
PERSONAL SKILLS
 Great willingness to learn new things
 Punctuality, sincerity, discipline and optimism are the hallmarks of my personality
 Good Communication skills and Good leadership qualities
 Self motivated and self drive
HOBBIES
 Playing Cricket and Net Browsing
 Like to get involved with Social welfare organizations
PERSONAL INFORMATION
Date of Birth : 26th Oct 1987
Gender : Male
Father’s Name : Mr. Mogili Kotha
Marital status : Single
Languages known : Telugu, English, Hindi and Kannada
Address : Ashok Kotha S/o Mogili
#7-77, Kashimpally, Bhupal Pally,
Warangal-506169, Telangana, India.
E-Mail & Phone No. : ashok.kotha999@gmail.com, 07829696686.
DECLARATIO
I hereby declare that above furnished information is true to best of my knowledge.
Place: Ashok Kotha
Date: