G. SIVA KUMAR
VISAKHAPATNAM
Summary
Experienced Sr. Manager in quality control and quality management systems within pharmaceuticals. Expertise in QC laboratory management, API testing, and regulatory compliance, focusing on continuous improvement and process optimisation. Leads strategic initiatives, oversees OOS/OOT investigations, and implements cGMP standards for high-quality outcomes. Facilitates cross-functional coordination and digital transformation within QC, ensuring laboratory efficiency and robust documentation for regulatory compliance.
Overview
1
1
Language
18
18
years of professional experience
Work History
Sr. Manager (QC QMS & IPFP)
Dr. Reddy's Laboratories Limited
Visakhapatnam
04.2016 - Current
- Leading quality management system (QMS) implementation and improvement projects, driving continuous enhancement of quality processes and procedures to meet regulatory requirements and industry standards.
- Led strategic planning initiatives in the Quality Control Department, optimising processes and ensuring compliance with quality assurance (QA) and quality control (QC) standards in the pharmaceutical sector.
- Collaborated with cross-functional teams to develop and implement quality assurance strategies, focusing on risk management, compliance, and continuous improvement in pharmaceutical manufacturing.
- Directed team of 18, allocating work based on task complexity and employee competencies, while leading technical discussions and troubleshooting.
- Enforcing cGLP and ALCOA standards in daily laboratory operations, prioritising rigorous documentation, safety protocols, and comprehensive compliance.
- Heading investigations and management of Out of Specification (OOS) and Out of Trend (OOT) incidents, while supervising related incidents and change controls.
- Evaluating audit trails of chromatographic systems and standalone instruments, formulating trend reports using FMEA, and representing as the SME during audits for lab compliance and investigation discussions.
- Pioneering digital and automation processes in the QC department, managing outside sample analysis, and utilising SAP software systems.
Sr. Manager (QC QMS & IPFP)
Cipla Ltd.
03.2015 - 03.2016
- Directed 2 teams (QMS and QC) of 10 members in the Quality Control department.
- Managed QC notifications for incidents, out-of-specifications, and deviations to ensure timely resolution and compliance.
- Reviewed and approved analytical data, SOPs, MOAs, WS qualification protocols, and instrument calibration procedures to uphold quality standards and regulatory compliance.
- Implemented cGLP and ALCOA standards in laboratory operations to enhance documentation accuracy and maintain safety protocols.
- Ensured data integrity and monitored compliance within the laboratory.
- Facilitated method transfers of newly developed products for routine use in QC.
- Defined key result areas for team performance evaluation.
Senior Executive
Aurobindo Pharma Ltd.
04.2009 - 03.2015
- Led daily Quality Control activities for operational efficiency and compliance.
- Directed sampling and analysis of in-process bulk, finished products, and raw materials to ensure compliance with quality standards.
- Directed Out of Specification (OOS) and Out of Trend (OOT) investigations for corrective actions.
- Managed incidents, deviations, and change controls with precision.
- Conducted training sessions and integrated quality systems to enhance laboratory performance.
- Supervised calibration and troubleshooting of instruments such as HPLC (UV, RI & PDA detector), pH meters, and balances.
- Delegated tasks, monitored progress, assigned responsibilities, and supervised activities to foster effective team collaboration.
- Defined critical performance metrics to assess operational success.
- Addressed and resolved party queries and market complaint samples.
Education
M.Sc. - Organic Chemistry
Andhra University
01-2008
B.Sc. - Chemistry
Nagarjuna University
01-2006
Skills
Quality Management Systems
- cGMP Compliance and Pharmacopoeial Standards
- Regulatory Inspection Support
- Laboratory Audit Readiness
- Instrument Calibration and Qualification
- Analytical instrumentation
- HPLC – High Performance Liquid Chromatography
GC – Gas Chromatography
- UV-Visible Spectrophotometer
- FTIR Spectrophotometer
- API quality control
- API testing
- Assay and Related Substances Analysis
- Analytical Method Troubleshooting
- Data integrity compliance
ALCOA Data Integrity Principles
- Documentation practices
- OOS/OOT Investigations
- Root Cause Analysis (RCA)
- CAPA management
- Change control
- SOP management
- Method validation
Analytical Data Traceability and Documentation
- Sample analysis
- Sample management
- Results documentation review
- QC Laboratory Management
- Laboratory Equipment Management
- Laboratory Safety and Chemical Handling
- Instrument & Laboratory Management
Data review
- GAMP 5 knowledge
- QC Team Leadership and Supervision
- Analyst Training and Competency Development
- Work Allocation and Performance Monitoring
- Resource management
- Work Allocation and Performance Monitoring
Personal Details
Languages: English, Telugu & Hindi
Accomplishments
- Received "Anjireddys Excellence Award" for the product CIPRODEXA successful laucnh in US market
Linkedin profile
www.linkedin.com/in/shiva-kumar-gedela-3b42409b
Awards & Achievements
Achieved commendation for Exceptional contributions during a USFDA audit., Recognized and awarded by Dr. Reddy's Laboratories for investigating and resolving unknown peak issues in preservative content testing via HPLC, utilizing FMEA tools (Fishbone and 6M) and implementing effective CAPA, while reducing incidents for the product.
Timeline
Sr. Manager (QC QMS & IPFP)
Dr. Reddy's Laboratories Limited
04.2016 - Current
Sr. Manager (QC QMS & IPFP)
Cipla Ltd.
03.2015 - 03.2016
Senior Executive
Aurobindo Pharma Ltd.
04.2009 - 03.2015
M.Sc. - Organic Chemistry
Andhra University
B.Sc. - Chemistry
Nagarjuna University