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
Advanced experience in Quality Assurance procedures, National and International regulations with regard to Good Manufacturing Practices
Proven expertise in assuring that appropriate Quality procedures are followed and controls are maintained during manufacturing
Excellent communication, training coordinator, organizing skills blended with rich interpersonal and people management ability
Having good experience in process quality assurance personnel involving in various shop floor activities
Having good experience in preparing & Review of APQR's (Annual Product Quality Review), Trends
Having good experience in preparing of BMR's, BPR's and SOP's
Having good experience in review of Executed BMR's & BPR's
Having good experience in Development Quality Assurance
Having good experience in Analytical Quality Assurance
Having good experience in Vendor Management Systems
Having good experience in Quality Management Systems
Having good experience in reviewing documents in-line with regulatory requirements
Having good experience while interacting with various departments for collecting documents and reviewing the same as per the regulatory submissions
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