Ravinder Reddy Maddelabeed
Hyderabad
Summary
Innovative pharmaceutical professional with increased responsibilities, Proficient in prioritization , attentive to details and able to work with sense of quality with productivity.
Have 10+ years of Experience in Pharmaceutical Quality systems, Quality management systems, Quality operations, and manufacturing compliance of sterile pharmaceuticals.
A good team leader with interpretational skill and committed to excellence
Accomplished Quality Assurance Lead with abundant knowledge of industry practices, processes and quality management.
Overview
11
11
years of professional experience
Work History
Quality Management Coordinator
Anthea Pharma pvt Limited
Hyderabad
07.2022 - Current
- Expert in lead, Preparation , Review and Approval of Investigations of manufacturing process failures, EM excursions, OOL, OOS , Media fill failures and handling of market complaint investigations with effective data analysis and right CAPA.
- Experience in preparation and integration of Quality Risk Assessments in to design and Qualification of clean areas, equipment, manufacturing process.
- Experience in change control and CAPA assessments, review, Approval, implementation and communication, closure.
- Good organizing and presenting Quality review meetings with effective data analysis in good PPTs.
- Performed root cause analysis on non-conforming products to determine corrective action plans.
- Implemented corrective actions based on audit findings and customer feedback.
- Coordinated activities between internal departments as required by the Quality Management System.
- Tracked progress of corrective actions taken for identified non-conformances.
- Prepared reports summarizing operations performance against defined metrics.
- Participated in internal audits ensuring that all requirements are met according to guidelines.
- Collaborated with management teams to develop process improvements aimed at enhancing overall product quality.
- Documented all changes made within the QMS system following an approved change request procedure.
- Ensured that all employees comply with the Quality Management System policies and procedures.
- Good document management , Good Governance, data integrity and Quality culture.
- Experience in training on cGMP, Quality management system and Guidance's.
- Experience in landing the team with aspiration and setting a bench mark for each Quality management function.
- Conducted regular inspections of production processes to ensure conformance to specifications.
- Trained new employees on QMS Procedures .
Quality Management Supervisor
Eugia pharma specialities limited Unit-III
Hyderabad
01.2017 - 07.2022
- Preparation, review of Manufacturing process investigations.
- Review and implementation CAPA
- Review and Implementation of Change controls
- Preparation, review and compliance of Quality management SOPs .
- Preparation and review of OOL, OOS , Market complaint manufacturing investigations.
- Preparation, Review and implementation of Quality risk assessments associated with production process , equipments.
- Developed and implemented quality management systems to ensure compliance with ICH guidelines.
- Planned, directed, and coordinated activities of personnel engaged in production and assurance operations.
- Evaluated conformance of products to established standards.
- Conducted root cause analysis on customer complaints and identified corrective actions to prevent reoccurrence.
- Monitored production output to ensure that it meets specified requirements for safety, reliability, durability, performance, and quality.
- Investigated potential non-conformances reported in manufacturing process.
- Trained personnel on Quality Assurance principles and techniques.
- Performed risk assessments on existing processes in order to identify potential problems before they occur.
- Monitored Quality elements trends and implemented CAPAs.
Manufacturing Production Associate
Mylan laboratories SFF division Bangalore.
Bangalore
08.2015 - 01.2017
- Developed and implemented production schedules to ensure timely completion of batch manufacturing activities.
- Ensured safety regulations were followed by all personnel in the production area.
- Maintained accurate records of daily production activities.
- Supervised a team of 20+ employees, ensuring tasks were completed efficiently and accurately.
- Conducted regular performance reviews for each employee to identify areas for improvement.
- Assisted with troubleshooting equipment malfunctions or operational problems as needed.
- Collaborated with management team to develop strategies for improving efficiency in the production area.
- Identified opportunities for process improvements through analysis of existing workflows.
- Established and updated production schedules to meet changing demands.
- Completed production plans by scheduling and assigning personnel, revising schedules and establishing priorities.
- Recommended and implemented measures to improve production methods and quality of products.
- Maintained top-notch quality control standards and eliminated downtime to maximize revenue.
- Issued work orders for repairs to plan maintenance of equipment, machinery and vehicles.
- Monitored manufacturing variances to achieve quality improvement while resolving product process and equipment problems.
- Set up, adjusted and maintained machines to operate at peak levels and meet challenging demands.
- Developed and implemented significant process improvements to enhance department quality and throughput.
- Assigned tasks to employees and monitored productivity, performance and task completion.
- Observed and monitored utilization of equipment.
- Directed and coordinated production activities, encouraging employees to meet specifications.
- Conducted training in equipment operations and safety procedures, briefing employees of hazards associated with work.
- Prepared operations data to produce comprehensive reports to management.
- Ordered equipment parts and repair services during equipment breakdown to avoid further delays.
Production Supervisor
Aspiro Pharma limited
Hyderabad
09.2013 - 09.2015
- Responsible for all the activities in Water System area, Compounding area, Autoclave and part preparation
area, Washing, Tunnel and sealing area, Filling area and Lyophilizer area - Verify/ensured the Indenting and issuance of Raw materials, Primary packaging materials as per the production plan through ERP.
- Receipt, Transfer and Return of Raw materials required for Batch production.
- Monitoring of environmental conditions like Temperature, Differential Pressures and Relative Humidity as per SOP.
- Ensured the Process flow, Personnel flow; Material flow shall be done as per the pre-defined procedures.
- Monitoring of Cleaning and Sanitization of the areas as per SOP.
- Coordination with validation team during qualification and re-qualification of equipment/area.
- Monitoring of Water System, Compounding, Autoclave, Washing, Tunnel and sealing, filling and Lyophilizer.as per the SOP.
- Ensured Prior intimation to validation team regarding any qualification, re-qualification of area, equipment and facility.
- Batch Planning and man power management as per the requirement.
- Preparation and review of SOP’s, and review of Batch records and process related protocols.
- Initiation, review and timely closure of all QMS elements like Change control, PNC, Exceptions and CAPA.
- Attending trainings like on job, cGMP, External and Giving training on process related SOP’s.
- Updating cGMP related practices and recent regulatory up gradation to the personnel working in the shop floor to improve the systems.
Education
B Pharmacy
HKES College of Pharmacy
Gulbarga09-2011
Intermediate
Sri Vikas Junior College
Mahaboobnagar06-2007
Secondary School education
Sri Vivekananda Vidyalayam,
Nrayanpet05-2003
Skills
- Quality Process Analysis
- Work Planning and Prioritization
- Deviation management
- CAPA management
- Change management
- QRM management
- Document Control
- Quality improvements implementation
- Trend Analysis
- Audit Coordination
- Progress Reporting
- Quality assurance experience
- Risk Analysis and Mitigation
- Regulatory Compliance
- Internal Audits
- Quality Systems
- Complaint Investigation
- Data Collection
- Documentation Review
- Data Analysis
- QA reporting
- Quality Management Systems
- Corrective Actions
Accomplishments
- Best Employee Award for the Year 2020.
- Best Employee Award for the Year 2018.
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Kannada
Upper Intermediate (B2)
B2
Timeline
Quality Management Coordinator
Anthea Pharma pvt Limited
07.2022 - Current
Quality Management Supervisor
Eugia pharma specialities limited Unit-III
01.2017 - 07.2022
Manufacturing Production Associate
Mylan laboratories SFF division Bangalore.
08.2015 - 01.2017
Production Supervisor
Aspiro Pharma limited
09.2013 - 09.2015
B Pharmacy
HKES College of Pharmacy
Intermediate
Sri Vikas Junior College
Secondary School education
Sri Vivekananda Vidyalayam,
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