RESUME :
Suresh Golla
Masters in Pharmacy
Contact Number : + 919542125736
Email:mavarick.suresh AT gmail.com
SUMMARY OF PROFILE :
Master’s in pharmacy having 3 years and 3 months of experience in Clinical Research and presently associated with QPS Bioserve India Pvt., Ltd., as Quality Assurance Executive. I have been involved in auditing more than 150 Bioavailability/Bioequivalence studies in all major therapeutic areas for domestic, US-FDA and EU regulatory submissions. Well trained in Protocols, GCP, SOPs and regulatory guidelines. I have faced US-FDA, EU audits.
CAREER OBJECTIVES :
Seeking a growth-oriented position in an organization where my knowledge and skills will be enhanced as well as utilized for the growth of the organization and further contributing in achieving my long term goal.
CURRENT EMPLOYMENT :
2015 February to till date at QPS Bioserve India Pvt Ltd, Hyderabad. As Quality Assurance Executive.
Responsibilities :
** To review the Case Report Forms, ICF’s, Study documents, and Final Study Reports, to ensure the study was performed in compliance to Protocol, Study Procedure Plan, Report Analysis Plan and SOPs.
** To monitor the clinical study activity performed in compliance to Protocol, Study Procedure Plan and SOPs.
** Coordinate with Regulatory Inspections, Sponsor audits and compliance.
** To review the Case Report Forms, ICF’s, Study documents, and Final Study Reports, to ensure the study was performed in compliance to Protocol, Study Procedure Plan, Report Analysis Plan and SOPs.
** Preparation and review of protocols and informed consent forms.
** Involved in Initiation, Monitoring and closing of Change Control and Deviation documents.
** Responsible for conducting internal audit & monitoring the same.
** To assist Manager QA in resolving the clinical and bio analytical queries from various regulatory authorities.
EDUCATIONAL QUALIFICATIONS :
** Master’s in pharmacy(Pharmaceutical Analysis & Quality Assurance)from Kakatiya university (KU), Warangal, India with 81%.
** Bachelor of Pharmacy from Vishwateja college of Pharmacy affiliated to Kakatiya university (KU), Warangal, India with 70%
** Intermediatefrom Board of intermediate with 88.7% studied at SR Junior College, Warangal, Telangana.
** S.S.Cfrom Board of Secondary education with 81% studied at Daffodils High School at Warangal, Telangana.
ACADEMIC PROJECTS :
As part of M.
Pharm : Method Development and validation of HPLC-MS/MS method for the determination of PITAVASTATIN in Human Plasma. was conducted at Piramal Clinical Research, A Division of Piramal Healthcare Pvt., Ltd., Hyderabad.
WORKSHOPS & TRAININGS :
** Participated in 4th student congress by INDIAN PHARMACEUTICAL ASSOCIATION at St. peter’s institute of pharmaceutical sciences, Warangal.
** Attended three-day workshop on ICH GCP, Regulatory guidelines, Quality Management and Personality development was conducted by QPS Bioserve India Pvt., Ltd., Hyderabad.
** Attended a training program on the topic “Basics of GCP’ was conducted at Nizam’s Institute of Medical Sciences, Hyderabad.
POSITIVE SKILLS :
** Good interpretational skills and friendly attitude makes me a good team player. I have a purposiveness, confidence and objectiveness, meticulous, hardworking and dedicated to being part of a progressive organization.
** Fun loving person and enjoy in reading science books
** Sports enthusiast - Athletics, cricket and tennis.
STRENGTHS :
** Ability to work both individually and in a matrix environment
** Motivated, hardworking, resourceful and pro-active person
** Good verbal and written communication skills
** Enthusiastic quick learner
PERSONAL PROFILE :
Date of Birth : 10 August 1989
Gender : Male
Marital status : Married
Languages : Telugu (Mother Tongue), English and Hindi.
DECLARATION :
I hereby solemnly declare that all the statements made in the application are true, complete and correct to the best of my knowledge and belief.
DATE :
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