PRADEEP BANDI
Quality Manager
Menifee
Summary
Results-driven Quality Assurance professional with extensive pharmaceutical manufacturing experience in solid dosage forms, semisolid dosage forms, and liquid products, seeking to contribute QA leadership expertise within a regulated drug product manufacturing organization. Skilled in managing cGMP quality systems, FDA regulatory compliance, inspections, deviation investigations, change controls, CAPA programs, batch record review, validation activities, and quality documentation. Experienced in leading cross-functional teams, developing personnel, and driving continuous improvement initiatives while ensuring product quality, operational excellence, and regulatory compliance.
Overview
11
11
years of professional experience
Work History
Quality Manager
HealthPlus
01.2019 - Current
- Led the revamp and implementation of SOPs by updating existing processes, creating clear documentation and training materials, and trained employees to ensure consistent, efficient, and GMP compliant operations.
- Collaborated with cross-functional teams to ensure the timely release and availability of raw materials, in-process bulk material and finished goods, supporting smooth operations and on-time delivery commitments.
- Coordinated internal and external audits, including vendor audits, ensured the timely implementation of CAPAs and their effectiveness.
- Provided QA oversight for GMP documentation and quality systems, including batch record review, deviation and complaint investigation management, CAPA execution, change control approval, risk assessments, and Annual Product Reviews to ensure product quality, regulatory compliance, and continuous process improvement.
- Implemented KPI tracking systems to monitor quality performance and support Management Review.
- Developed product specifications, protocols for process validation, stability, IQ/OQ/PQ of manufacturing and lab equipment.
- Developed and mentored in development and validation of analytical test methods and their use in routine analytical testing of raw materials, bulk products, and finished products.
- Implemented an in-house stability program to support the expiration date of finished products.
R&D Chemist/QC Laboratory Supervisor
Emilia Resources LLC
01.2016 - 01.2019
- Developed and validated several analytical test methods using various instrumentation such as HPLC, GC, etc.
- Supervised laboratory personnel and laboratory activities and ensured timely release of raw materials, bulk materials, and finished products.
- Represented QC laboratory during client and FDA audits.
- Assisted in 510(k) and other filings with FDA.
- Served as a Certified LabWare LIMS Administrator, leading LIMS configuration, implementation, and system enhancements to streamline laboratory processes, improve data management, ensure compliance with GMP requirements, and support digital transformation initiatives.
Education
Master of Science - Biology
Mississippi Christian University
Clinton, MS01.2016
Master of Science - Chemistry
Mississippi Christian University
Clinton, MS01.2014
Bachelor of Pharmacy - undefined
Jawaharlal Nehru Technological University
Hyderabad, India01.2012
Skills
- Extremely knowledgeable in 21CFR 211, 111, 11 etc And their compliance
- Extensive knowledge in analyzing data and assess potential improvement
- Multi-tasking
- Strong computer-based skills such as MS office, SAP, Priority chromeleon, Empower, QCBD, LIMS etc
- Strong verbal and communication skills
- Audit Management (Internal, Vendor and Regulatory)
Accomplishments
Demonstrated ability to establish and lead quality systems and process improvement initiatives from the ground up, including in-house stability program, calibration program, foreign supplier/vendor qualification program, analytical laboratory operations, data integrity program, data-driven formulation and process optimization, and Laboratory Information Management System (LIMS) configuration and implementation. Successfully managed cross-functional projects to enhance compliance, operational efficiency, and product quality.
Timeline
Quality Manager
HealthPlus
01.2019 - Current
R&D Chemist/QC Laboratory Supervisor
Emilia Resources LLC
01.2016 - 01.2019
Bachelor of Pharmacy - undefined
Jawaharlal Nehru Technological University
Master of Science - Chemistry
Mississippi Christian University
Master of Science - Biology
Mississippi Christian University