GANGANOLLA RANJITH KUMAR
Hyderabad
Overview
8
8
years of professional experience
Work History
Sr. Executive in Quality Assurance
RiconPharma Pvt.Ltd.
Hyderabad
07.2022
- Ensure & Review of all documents comply with regulations for various submissions
- Maintain thorough documentation of compliance processes and approvals
- Responding to regulatory queries
- Responsible for Customer / Regulatory Audit responses
- Coordinating to the external/regulatory audits
- Coordinating with vendors regarding the material quality complaints and issue resolving for all the material quality complaints
- Performing the audits for API, packing material manufacturers and suppliers, also Contract testing labs, Service providers
- Preparation, review and approval the technical agreements for all the manufacturers, suppliers, contract testing labs & service providers
- Performing the audits for CMO's
- Preparing the vendor audit reports and follow-uping for CAPA
- Preparing the internal audit schedules and performing the internal audits as per the schedule for various departments
- Review of Risk Assessment Reports (Elemental Impurities, Residual solvents, Nitrosamines & NDSRI's) Handling & Review of Change Controls, Incidents, deviations, OOS, OOT of CMO's
- Handling of QMS, TMS, DMS activities through Pragma-WFM software
- Handling of Projects for dossgae forms Liquids_ Sterile (Injectable & Ophthalmic suspensions) & Solids - (Tablets) Responsible for monitoring of process validation batches at CMO sites
- Coordinating with the all departments for training activities as per the schedules and documenting all the training activities.
Sr. Executive in Quality Assurance
Biological E. Limited
Hyderabad
07.2021 - 07.2022
- Maintaining all documents according to regulatory requirement
- Providing necessary documents for regulatory submissions
- Responding to regulatory queries
- Responsible for Customer / Regulatory Audit responses
- Conducting internal audits and coordinating to the external/regulatory audits
- Review of batch related documents for its completeness and compliance and release of batches
- Review & Approval of Artworks
- Preparation and Review of APQR's (Annual Product Quality Review).
Sr. Executive in Quality Assurance
Suven Pharmaceuticals Limited
Telangana
02.2017 - 07.2021
- Performing Vendor Qualification for API, Excipients & all packing materials
- Preparation of audit schedules for vendors, suppliers & service providers
- Performing the audits for API, Excipients& Packing material manufacturers and suppliers
- Preparing the vendor audit reports and follow-up for CAPA
- Preparing the approved vendor master list for all API, Excipient and packing materials
- Performing the conditional (Provisional) approval for vendors
- Preparing the internal audit schedules and performing the audit as per the schedule for various departments
- Preparation of technical agreements for vendors, suppliers & external labs
- Performing the Risk assessment for all raw materials
- Handling of Quality complaints related to raw materials and packaging materials by coordinating with purchase department
- Coordinating with vendors for getting required documents and audit dates
- Maintaining all documents according to regulatory requirement
- Providing necessary documents for regulatory submissions
- Responding to regulatory queries
- Responsible for Customer / Regulatory Audit responses
- Conducting internal audits and coordinating to the external/regulatory audits
- Review & Approval of Artworks
- Coordinating for dispatch of product release activities
- Preparation and Review of APQR's (Annual Product Quality Review)
- Preparation and Review of Elemental Impurities Risk Assessment Reports for the Drug Products
- Handling of the transportation study activities
- Review of batch records
- Reviewing the all new product introduction into the facility
- Preparation of cleaning validation/verification protocols and reports
- Preparation of process validation protocols and reports
- Monitoring all the new products and collecting the validation samples as per protocols
- Responsible for preparation of Hold Time Study protocols and reports
- Responsible for review and compilation of data obtained while process validation activity
- Responsible for performing IPQA activities i.e., line clearance, In-process checks for critical operations in accordance to SOP, collection of in-process samples.
Quality Associate in Quality Assurance
Graviti Pharmaceuticals Private Limited
Telangana
06.2014 - 01.2017
- Preparation of the product hold time studies and preparation of the summary report as per the guidelines
- Preparation of process validation protocols and coordinating in execution of validation activities and process validation summary report for the products manufactured for regulatory markets
- Preparation of Packaging validation protocols and coordinating in execution of validation activities
- All the process validation activities are done based on the Risk Based Approaches
- Responsible for giving line clearance at various stages like dispensing, granulation, blending, compression, coating, capsule filling, inspection and packing
- Responsible for monitoring of Granulation, Compression, Coating, Capsule filling, Inspection and Packing activities as per batch manufacturing records (BPRRs) and Batch Packaging record (BPARs)
- Responsible for monitoring of Process Validation batches
- Responsible for entries in BMR's & BPR's
- Responsible for assurance of cGMP practices as per written procedures
- Responsible for performing in process checks at granulation, compression and coating, packing
- Responsible for reporting and investigation of Deviations, Non conformances (incidents) and Change controls in the shop floor
- Responsible for online collection of samples during manufacturing and packing activities and submitting to QC, Microbiology and Stability
- Responsible for daily checking of equipment logs, calibration logs, equipment PMP status as per master calibration and PMP schedules
- Responsible for review of BMR's & BPR's
- Responsible for calibration of in process IPQA instruments like Disintegration equipment, Friabilator, Moisture analyzer
- Responsible for area compliance, SOP compliance during audit time
- Review of Method Validation Protocols & Reports
- Review of Method Verification Protocols & Reports
- Review of Executed Analytical Records
- Review of API, Excipients, In-process, Packing, Finished Product and Stability specifications/ STP's for US markets
- Review of CoA's, GTP's and SOPs (Instrument Related)
- Revision of Specification, STP & Work sheets as per current Pharmacopeial requirements
- Review of Equipments & Instruments Calibration Reports.
Education
M.Pharmacy - undefined
Arya College of Pharmacy, Osmania University
Hyderabad, T.SB.Pharmacy - undefined
Arya College of Pharmacy, Osmania University
Hyderabad, T.SIntermediate - undefined
Board of Intermediate Education, MNR College of Pharmacy
HyderabadSSC - undefined
Board of Secondary Education, Telangana
Skills
Competent professional with 10 years of experience in Quality Assurance in Pharmaceutical industry
Personal Information
- Date of Birth: 01/31/92
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Timeline
Sr. Executive in Quality Assurance
RiconPharma Pvt.Ltd.
07.2022
Sr. Executive in Quality Assurance
Biological E. Limited
07.2021 - 07.2022
Sr. Executive in Quality Assurance
Suven Pharmaceuticals Limited
02.2017 - 07.2021
Quality Associate in Quality Assurance
Graviti Pharmaceuticals Private Limited
06.2014 - 01.2017
M.Pharmacy - undefined
Arya College of Pharmacy, Osmania University
B.Pharmacy - undefined
Arya College of Pharmacy, Osmania University
Intermediate - undefined
Board of Intermediate Education, MNR College of Pharmacy
SSC - undefined
Board of Secondary Education, Telangana
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