Damodar Chary Kumara
Quality Assurance Professional
Nizampet,TG
Summary
Having 14.9 Years of experience in pharmaceutical industry in Quality Assurance & Production Department of sterile liquid Parental manufacturing.
Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
15
15
years of professional experience
1
1
Language
Work History
Deputy Manager (QA)
EUGIA Pharma specialities
11.2016 - Current
- Responsible for monitoring of all IPQA activities in the shop floor.
- Responsible for ensuring the shop floor compliance.
- Responsible for planning and allocating the IPQA manpower to the manufacturing & filling areas for IPQA activities.
- Planning and allocating manpower to the scheduled PV, CV and media fill activities.
- Execution of Media fill validation, process validation and cleaning validation protocols.
- Review of batch manufacturing and batch packing records.
- Responsible for Batch release activities.
- Preparation of COC, verification COA and ensuring the compliance of all QMS elements related to batch release activity.
- Review of media fill summary reports, process validation summary reports and cleaning validation summary reports.
- Review of aseptic area operations through CCTV for verification of aseptic behaviour and practices.
- Conducting on job trainings to the team members.
- Review of environmental monitoring reports, log books and non-viable particle monitoring data of aseptic process area.
- Performing the LIMS registration of samples (IP, PV, HS, CV & FP) to generate the A. R. No. and submission of samples for analysis.
- Review of NVPC, Intervention, critical alarms and CCTV quarterly trends.
- Review of SOP's and performing gap assessment (SOP vs Practices).
- Handling of change controls, Deviations, investigations and CAPA’s related to manufacturing.
- Preparation and review of QRM (Quality Risk Management).
- Preparation and review of OOS/OOT manufacturing investigations and ensuring the CAPA implementation.
- Actively Participated as a team member in USFDA, Health CANADA regulatory audits.
Officer (Packing department)
SHILPA MEDICARE LIMITED
07.2014 - 11.2016
- Responsible for monitoring of all packing activities in the shop floor.
- Performing visual inspection of product filled vials and media filled vials.
- Responsible for labelling and packing activities.
- Responsible for Preparation of SOPs and batch packing records.
- Actively Participated as a team member in 02 USFDA audits.
Junior Executive (Quality Assurance-QA)
EPSILON PHARMACEUTICALS
01.2014 - 04.2014
- Responsible for monitoring of all IPQA activities in the shop floor.
- Involved in Documentation optimization and SOP simplification.
- Preparation of SOP's and miscellaneous/ In-house protocols.
- Review of Qualification protocols (DQ, IQ, OQ and PQ) for HVAC system, Dynamic pass box.
Chemist (Quality Assurance-IPQA)
GLAND PHARMA LIMITED
11.2010 - 01.2014
- Responsible for monitoring of all IPQA activities in the packing area.
- Responsible for providing the line clearance for packing and visual inspection activities.
- Responsible for performing the in-process checks (AQL) during and completion of visual inspection activities.
- Responsible for performing the in process checks during labelling, overprinting and packing activities.
- Responsible for collection of samples (Control samples, Identification samples and stability samples)
- Responsible for performing spot check of packed shippers.
- Review and compilation of batch packing records.
- Responsible for Conducting the visual inspection qualification to the operators.
- Responsible for preparation and up dation of visual inspection qualified operators list.
- Responsible for Preparation of visual inspection qualification kits of various containers (Vials, ampoules and PFS).
- Actively Participated as a team member for the below regulatory audits success. USFDA, MHRA, ANVISA, TGA.
Education
B. Pharmacy - Pharmacy
MESCO College of Pharmacy (Osmania University)
Hyderabad, Telangana, India01.2007
Intermediate - undefined
SPECTRA Junior college (Board of Intermediate)
Hyderabad, Telangana, India01.2002
SSC - undefined
Vivekananda Vidyalayam (Board of secondary school education)
Nizamabad, Telangana, India01.1999
Skills
Quality assurance during production
Execution of process validation
Aseptic process evaluation
Thorough review of batch documentation
Batch release management
Effective collaboration in teams
Risk assessment
Interests
Visiting the new places and interacting with the people
DECLARATION
I, hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
Deputy Manager (QA)
EUGIA Pharma specialities
11.2016 - Current
Officer (Packing department)
SHILPA MEDICARE LIMITED
07.2014 - 11.2016
Junior Executive (Quality Assurance-QA)
EPSILON PHARMACEUTICALS
01.2014 - 04.2014
Chemist (Quality Assurance-IPQA)
GLAND PHARMA LIMITED
11.2010 - 01.2014
Intermediate - undefined
SPECTRA Junior college (Board of Intermediate)
SSC - undefined
Vivekananda Vidyalayam (Board of secondary school education)
B. Pharmacy - Pharmacy
MESCO College of Pharmacy (Osmania University)