Pavan Gutti
Quality specialist
Indore,Madyapradesh
Summary
To join an organization where I could get a challenge position and responsibilities, which utilize my qualification and experience and help me in making successful career.
Overview
15
15
years of professional experience
Work History
Deputy Manager
Endo Pharmaceuticals
Indore
06.2020 - Current
- Overview:
- Responsible for QMS activities, investigating laboratory non-conformances, OOSs, OOTs, and CAPAs related to internal and external audits through the Trackwise digital software.
- Responsible for conducting the internal audits in quality control and cross-functional teams.
- Responsible for preparation of Quality board review meeting presentations for senior management meetings.
- Review and Approval of specifications, standard test procedures, and Standard operating procedures, Summary reports, and protocols.
- Providing training to the team members on applicable procedures and QMS.
- Monitoring of analytical activities related to analytical method transfers.
- Timely planning and completion of analysis of Stability, In-process, finished product, Hold time studies, and Cleaning samples.
- To maintain cGLP, documentation and implementation of departmental quality systems in the laboratory.
- To coordinate with third parties for Outside Lab testing and routine services.
- Monitored daily operations and ensured compliance with company policies and regulations.
- Coordinated with other departments to ensure smooth functioning of activities.
Assistant Manager Quality Control
Dr. Reddy’s Laboratories
Hyderabad
03.2015 - 06.2020
- Planning of Analytical method validation & method transfer activities
- Responsible for review of Instrument Audit trails, monthly, and yearly calibration schedules.
- LIMS (lab ware- 7) master review and approval for Laboratory Instrument and Laboratory Standard management
- Responsible for in-process, finished product, and stability testing program for drug products.
- Ensure compliance with all established quality systems within the lab.
- Handling, reporting, and closing of Incidence, CAPAs, OOT, and OOS, and conducting root cause investigations.
- Provide troubleshooting expertise and implement corrective action, report observations.
- Recommend changes to methods and operations, as appropriate.
Quality Control Management Staff
CIPLA ltd.
04.2014 - 03.2015
- Handling of OOS, OOT
- Analysis of stability samples, working standard qualification, maintenance of working standards and certified reference standards
- Carrying Analytical method validation & method transfer activities
Quality Control Officer
Glenmark Pharmaceuticals Pvt ltd.
07.2012 - 03.2014
- Calibration of QC Instruments
- Analysis of Process Sample, Semi-Finished, Finish Stability Sample & by Chemical and Instrument Method
Quality Control Management Staff
Golden Cross Pharma Pvt ltd
07.2009 - 06.2012
- Company Overview: (CIPLA)
- Calibration of QC Instruments
- Wet Lab Analysis (Raw, Semi finish, Finish product)
- Sampling & Analysis of Raw Materials
- Carry out the Good Laboratory practice
- (CIPLA)
Education
M.Sc. - Organic Chemistry
Nagarjuna University
01-2013
B.Sc. -
Nagarjuna University
01-2009
12th -
Nagarjuna University Education
01-2006
10th -
Board of Secondary School Education
01-2004
Skills
- Quality Control & Assurance
- Quality Management System
- Stability Study Management
- Electronic compliance
- SOP Management
- Quality documents
- Laboratory Investigations
- Human Error Reductions
- Qualification of instruments
- Training and development
- Audits & Inspections
Auditcoordination
- WHO Audit, 2010, 2012, Golden Cross Pharma Pvt Ltd (CIPLA)
- US FDA Audit, 2015, 2017, 2019, Dr. Reddy’s (FTO 3)
- MHRA, ANVISA Audits, 2016, Dr. Reddy’s (FTO 3)
- US FDA Audit, 2021, 2023, 2024, Par Formulations Private Limited
Instruments Used
- HPLC (Shimadzu, Agilent, waters – chromeleon, Empower)
- UPLC (waters)
- UV (Shimadzu UV-1700, Lab India UV 3000+)
- Polari meter (Rudolph Autopol V)
- Autotitrator (Metrohm 809, Lab India)
- Disintegration Apparatus (Electro Lab)
- Dissolution Apparatus (Electro Lab, Lab India, Agilent)
- GC (Agilent)
Personal Information
- Total Experience: 15 years
- Father's Name: Venkateswarlu Gutti
- Date of Birth: 08/21/89
- Marital Status: Married
Accomplishments
- Pinnacle Award in 2020
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Timeline
Deputy Manager
Endo Pharmaceuticals
06.2020 - Current
Assistant Manager Quality Control
Dr. Reddy’s Laboratories
03.2015 - 06.2020
Quality Control Management Staff
CIPLA ltd.
04.2014 - 03.2015
Quality Control Officer
Glenmark Pharmaceuticals Pvt ltd.
07.2012 - 03.2014
Quality Control Management Staff
Golden Cross Pharma Pvt ltd
07.2009 - 06.2012
M.Sc. - Organic Chemistry
Nagarjuna University
B.Sc. -
Nagarjuna University
12th -
Nagarjuna University Education
10th -
Board of Secondary School Education
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