Gopi Krishna Velugoti

Executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical manufacturing equipment in accordance with cGMP, FDA, and GAMP 5 guidelines.

Performed qualification of formulation vessels, filtration vessels, and aseptic filling line equipment, including bag filling lines, vial filling lines, and prefilled syringe filling lines.
Developed, executed, reviewed, and approved IQ/OQ/PQ protocols and final reports while ensuring compliance with Good Documentation Practices (GDP).
Verified equipment installation, utilities, alarms, interlocks, instrumentation, and critical operating parameters during qualification activities.
Executed Process Performance Qualification (PPQ) for commercial manufacturing batches to demonstrate process consistency and reproducibility.
Performed Packaging Performance Qualification (PKV/Packaging Validation) to verify packaging operations and ensure compliance with product specifications and regulatory requirements.
Conducted Hold Time Studies for manufacturing and filling batches to establish validated hold times for bulk solutions and intermediates before batch release.
Executed Cleaning Validation for formulation vessels, filtration systems, and filling line equipment using validated Clean-in-Place (CIP) cycles.
Collected rinse and swab samples following CIP and coordinated testing with QC Microbiology for API residue, Total Organic Carbon (TOC), Conductivity, Bioburden, Endotoxin, and microbial analysis.
Performed Sterilization-in-Place (SIP) validation using the Kaye Validator by configuring thermocouples, positioning temperature probes at critical locations with Biological Indicators (BIs), executing SIP cycles, and coordinating BI incubation and result verification with the Microbiology team.
Conducted temperature and relative humidity mapping of warehouses, incubator rooms, and cold storage rooms during summer and winter seasonal qualification studies.
Utilized Sensitech TempTale data loggers to monitor, record, and analyze environmental conditions, ensuring compliance with storage qualification requirements.
Performed IQ, OQ, and PQ of Helmer and EquiChem laboratory refrigerators used by Quality Control and Microbiology laboratories for qualified sample storage.
Verified temperature distribution, temperature uniformity, alarm functionality, and operational performance of laboratory refrigerators within validated storage conditions.
Collaborated with Quality Assurance (QA), Quality Control (QC), Manufacturing, Engineering, Microbiology, and Production teams to execute qualification and validation activities while supporting timely batch release.
Ensured all validation documentation, protocols, reports, deviations, and supporting records complied with cGMP, FDA 21 CFR Part 210/211, ALCOA+ data integrity principles, and company SOPs.

Performed equipment and utility qualification (IQ, OQ, PQ) in compliance with cGMP and GAMP 5 guidelines for pharmaceutical and cosmetic production environments.

Led risk assessments and gap analyses to ensure compliance with internal quality systems and global regulatory requirements.

Developed and executed cleaning validation protocols (CVPs) for manufacturing equipment used in the production of active pharmaceutical ingredients (APIs) and cosmetic excipients.

Maintained compliance with internal Quality Management Systems (QMS) through strict adherence to SOPs, documentation practices, and change control procedures.

Participated in internal and external audits (regulatory and client) by preparing validation documentation and responding to audit queries related to GMP compliance.

Validation lifecycle: URS → DQ → IQ → OQ → PQ

Collaborated with cross-functional teams (QA, Production, Maintenance, R&D) to implement process improvements and ensure timely project execution.

Tools: MS Office, Mini Tab, Strong Knowledge in Lubcel interface working between equipments and system to operate equipments.

Deviation Management, CAPA, Change Control

• Developed qualification and validation deliverables, such as validation project plans, risk assessments, validation (IQ, OQ, and PQ) protocols, commissioning plans, commissioning, and validation summary reports.
• Worked on Oxygen and EU-MDR Project with needed Requirements: Ensuring that all PV documentation complies with the specific requirements of EU MDR, including documentation standards, timelines, and content.
• Regulatory Changes for project Oxygen and EU-MDR Staying updated on changes to EU-MDR regulations and adapting project plans and documentation accordingly.
• Ensuring the test environment mirrors production conditions, prepare realistic test data, execute functional, performance, and security tests, and thoroughly document results with logs and evidence of any issues or deviations.
• Deviations: Identified, investigated, and addressed deviations encountered during process verification and Software validations by analyzing root causes and implementing corrective actions.
• Responsible for reviewing design and process changes and assess impact to assure reliability requirements are met.
• Developed and execute IQ, OQ and PQ protocols for product, processes, and equipment within the facility.
• Understanding of CFR Title 21, ISO 13485 standards, and cGMP best practices is essential.
• Reviewed existing validation reports and identify gaps for GMP compliance, develop strategies and plans to close the gaps in an efficient and technical manner.
• Utilize enterprise resource systems for managing projects, overseeing configuration management, and handling change control.
• Compliance Verification: Ensuring that route sheets are updated to reflect current processes and meet regulatory and company standards.
• Accuracy and Precision: Maintaining accurate and precise route sheets to ensure consistency and quality in production.
• Defined validation approach developed protocols (IQ/OQ/PQ) and assisted in validation executions as required.
• Developed and completed manufacturing requirements (Manufacturing Changes MCs, PFMEA, control plan, process flow, work instructions, and inspection plans, NCRs) and Participated in NCMR, Process in containment, root cause analysis, and implementation of permanent corrective actions.
• Used structured problem-solving techniques (Brainstorming, 5Whys, FMEA, Fishbone Diagram) and statistical methods for data driven analysis and decisions.
• Developed Design of Experiments (DOE), process Failure Mode & Effect Analysis (PFMEA), product, process characterizations and validations.
• Worked on Design Validation and Verification to compare the Design Outputs to Design Inputs.
• Comprehensive knowledge of Product development life cycle, Traceability Matrix, DOE.
• Created Non-Conformance (NCR) Quality Notifications (QN) for lots/Batches which are defected and hold the finished goods.

Worked on course for Six sigma.