Ganganolla Ranjith Kumar
Hyderabad
Summary
Demonstrated expertise in leading CMO projects and fostering strong relationships, significantly improving quality standards and operational efficiency. Skilled in CAPA Management and team leadership, driving project success and ensuring adherence to regulatory guidelines. Highly experienced with a proven track record in managing quality assurance procedures and protocols. Possess deep understanding of regulatory compliance, product testing, and process improvement strategies. Demonstrated leadership abilities paired with exceptional analytical skills have consistently ensured delivery of high-quality products in previous roles. Known for fostering a work environment that values continuous learning and adheres to strict industry standards.
Overview
11
11
years of professional experience
Work History
Senior Executive - QA
Ingenus Pharmaceuticals LLC / RiconPharma India Pvt.Ltd.
Hyderabad
07.2022 - Current
- Monitor and ensure that the CMO adheres to Good Manufacturing Practices (GMP) and other regulatory standards
- Conduct regular quality audits of the CMO to assess compliance with quality agreements and regulations
- Conduct cause audits at the CMO site for any drug product quality issues
- Evaluate the CMO's quality systems, processes, and history to ensure they meet organizational standards
- Develop and review Quality Agreements between the organization and the CMO, outlining responsibilities, expectations, and quality standards and ensure that all terms are understood and adhered to by both parties
- Review and approve CMO-related manufacturing documentations, including batch records, manufacturing protocols & reports, study protocols & reports, Aseptic process simulation protocols & reports and validation documents
- Review and approve CMO-related analytical documentations, including stability study protocols & reports, transfer protocols & reports, verification protocols & reports
- Ensuring that all documentation meets regulatory requirements and internal standards for various submission
- Review & ensuring that all changes related to CMO are properly documented and assessed for impact on product quality
- Investigate any quality complaints or deviations that occur during manufacturing at the CMO and work with the CMO to implement corrective and preventive actions (CAPAs) as needed
- Act as a liaison between the organization and the CMO, facilitating communication and resolving any quality-related issues
- Regularly report on quality performance metrics and any concerns to internal stakeholders
- Stay informed about regulatory requirements and ensure the CMO's practices align with these regulations
- Provide training and support to CMO staff on quality standards and expectations
- Ensure that CMO personnel are adequately trained on the products being manufactured
- Assess and approve the release of finished products from the CMO based on compliance with specifications and quality standards
- Involving regularly in the telecon's with CMO for any technical discussion & projects updation
- Responsible for monitoring of registration batches & process validation batches at CMO sites
- Conducting audits for CMO & API sites to ensure compliance with cGMP requirements
- Managing vendor qualification and related activities, including vendor qualification and re-qualification for various materials & service providers and contract testing laboratories
- Preparation, review and approval the technical agreements for all the manufacturers, suppliers, contract testing labs & service providers
- Preparing the vendor audit reports and follow-uping for CAPA
- Coordinating with vendors regarding the material quality complaints and issue resolving for all the material quality complaints
- Assist in preparing responses to regulatory authority inquiries or requests for additional information
- Responsible for Regulatory Audit responses and Coordinating to the external/regulatory audits
- Preparing the internal audit schedules and performing the internal audits as per the schedule for various department
- Review of Product Development Reports (PDR's)
- Review of Risk Assessment Reports (Elemental Impurities, Residual solvents, Nitrosamines & NDSRI's)
- Review of protocols & reports for Method Validations, Method transfers, Method equivalency & Method development reports
- Review of MFR, Specifications, STP's and JOS
- Review of Leachable & Extractable study protocols & reports
- Review of BET, AET, Bioburden and Sterility Validation & Verification protocols & reports
- Handling of QMS, TMS, DMS activities through Pragma-W FM software
Senior Executive - QA
Biological E. Limited.
Hyderabad
07.2021 - 07.2022
- Assist in the preparation & compilation of documentation for regulatory submissions
- Ensure that all necessary documentation is accurate, complete, timely and aligned with the submission content
- Maintain a robust document management system for regulatory submissions and communications
- Provide insights and recommendations for adapting to new regulatory requirements
- Review and approve regulatory documents, ensuring clarity and compliance
- Participate in risk assessments to evaluate the regulatory implications of product changes or deviations
- Provide guidance on how to mitigate regulatory risks
- Monitor and interpret regulatory guidelines and requirements
- Assist in preparing responses to regulatory authority inquiries or requests for additional information
- Review of batch records & its related documents for its completeness and compliance
- Responsible for batch releases
- Review & Approval of Artworks
- Preparation and Review of APQR's (Annual Product Quality Review)
- Monitoring shop floor activities of manufacturing areas & packing areas
Senior Executive - QA & CQO
Suven Pharmaceuticals Limited.
Hyderabad
02.2017 - 07.2021
- Preparation & review of Master batch manufacturing records & master batch packaging records
- Preparation of process validation protocols/ Packaging validation protocols and coordinating in execution of validation activities
- Coordinating & collecting the data from respective CFT's for Preparation and review of process validation summary reports for the products manufactured for regulatory markets
- Preparation & Review of cleaning validation/verification protocols and reports
- Responsible for monitoring of Granulation, Compression, Coating, Capsule filling, Inspection and Packing activities as per batch manufacturing records (BMRs) and Batch Packaging record (BPRs)
- Responsible for reporting and investigation of Deviations, Non conformances (incidents) and Change controls of shop floor activities
- Preparation of protocols & summary reports of various studies like Hold time study, Homogeneity study, tubing study, white stock study, freeze-thaw study, in-use study, photostability study as per the regulatory requirement/guidelines
- Providing training sessions to responsible staff involving in batch executions and its related activities
- 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
- Preparation & Review of technical agreements for vendors, suppliers & external labs
- 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
- Preparing the internal audit schedules and performing the audits as per the schedule for various departments
- Assist in preparing for internal and external audits by organizing documentation and records
- Ensure records are complete, accurate, and accessible for audits and inspections
- Address any documentation-related findings from audits and inspections
- Responsible for regulatory responses
- Responsible for coordinating to the external/regulatory audits
- Preparation and Review of APQR's (Annual Product Quality Review)
- Review & Approval of Artworks
- Review of batch manufacturing records & batch packaging records
- Responsible for batch releases & coordinating for dispatch of product release activities
- Preparation and Review of Elemental Impurities, Residual solvents Risk Assessment Reports for the Drug Products
- Handling, preparation & review of the transportation study protocols and reports
- Reviewing the all-new product entities into the facility
- Responsible for performing the product mock recall activities
- Handling of QMS activities and preparation & review of its trend reports
Quality Associate - QA & DQA
Graviti Pharmaceuticals Private Limited.
Hyderabad
06.2014 - 01.2017
- Responsible for giving line clearance at various stages like dispensing, granulation, blending, compression, coating, capsule filling, inspection and packing
- 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 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 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
- Review of Reconciliation records of Working Standards/Reference Standards/Impurity standards
- Responsible for ensuring the quality control/analytical lab in accordance with GLP & cGMP requirements
- Had involved in the qualification activities of utilities & areas
- Responsible for ensuring & initiation of Temperature/RH Mapping studies through rotronic software in all the areas of site
- Responsible for downloading the Temperature/RH data, compile & prepare the reports
- Co-ordination with respective CFT's to collect the information and get updated and finalization of respective layout drawings as per the requirements
- Issuance of documents as per the request's forms of various departments
- Manage the creation, revision, and approval of all QA documentation
- Ensure that all documents are properly indexed, stored, and easily retrievable
Education
Master of Science - Pharmacy
Osmania University
Hyderabad01.2015
Skills
- Knowledge of Quality Systems
- Audits and cGMP compliance
- Regulatory Intelligence & Compliance
- Leading CMO Projects (National & International)
- Vendor Management Systems
- Root Cause Analysis & CAPA Management
- Risk Assessments
- Quality Management Systems
- Manufacturing Assurance
- Development Quality Assurance
- Analytical Assurance
- Documentation/DMS
- Collaboration skills
- Time Management skills
- Interpersonal Proficiency
- Communicator
- Decision Maker
- Problem-Solving Acumen
- Team management
- Project management
- Work Planning and Prioritization
- Analytical problem solving
- Relationship building
- Internal audits
- Regulatory compliance
- Continuous improvement
- Audit coordination
- Audit reporting
- Team building
- Risk analysis and mitigation
- Documentation review
Personal Information
- Date of Birth: 01/31/92
- Nationality: Indian
- Marital Status: Married
Passions
- Continuous Learning/Improvements
- Data-Driven Decision Making
- Process Optimization Enthusiast
- Technological Advancement follower
Accomplishments
- Awarded for Key Contributor of the Year
- Rewarded for Best Performance for Monthly & Quarterly
Languages
Telugu
First Language
Hindi
Proficient (C2)
C2
English
Proficient (C2)
C2
Timeline
Senior Executive - QA
Ingenus Pharmaceuticals LLC / RiconPharma India Pvt.Ltd.
07.2022 - Current
Senior Executive - QA
Biological E. Limited.
07.2021 - 07.2022
Senior Executive - QA & CQO
Suven Pharmaceuticals Limited.
02.2017 - 07.2021
Quality Associate - QA & DQA
Graviti Pharmaceuticals Private Limited.
06.2014 - 01.2017
Master of Science - Pharmacy
Osmania University
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