CHINNA NAGAMALLESWARA REDDY ALLA

SUMMARY:
CQV, Quality, manufacturing and validation professional with diverse engineering experience in R&D and production
over 7 years of experience.
• Worked on continuous quality improvement, benchmarking and six sigma projects in Drug, Biologics and
Medical device industry.
• I am a balanced leader with innovative thoughts, highly goal driven and a good team player with decision making
ability. My passion for the subject, quick learning ability and strong hands-on experience in various techniques.
• Technical expertise in manufacturing operations management systems for the end-to-end visibility of the
production, quality, inventory and maintenance operations.
• Extensive knowledge in Food and Drug Administration (FDA) regulations 21 CFR Part 11, 210, 211, 820, ISO
10993, 11135, 11737, 13408, 13485, 14644, 14971 (Safety and Risk Management), ICH Q7, Q8 Q9, Q10, USP 71,
113, GAMP, GxP, AAMI guidelines and EU regulations.

WORK EXPERIENCE:

Catalent Pharma Solutions, Harmans, MD Mar 2020 – Dec 2020

Quality/Validation Lead
• Responsible for production and continuous improvement projects for Cell and Gene therapy products.
• Team lead for Standard Manufacturing Processes like Growth Media preparation, Autoclaved material,
production media, buffers (ex: NaCl, wash, neutralization, elution, CIM QA, spike, BDS etc.,) for manufacturing
batch production records for review and approval.
• Reviewing and approving biological manufacturing processes including microbial and cell culture, cell banking,
fermentation/cell culture, purification, fill/finish and perform lot release activities.
• Strong working knowledge with upstream process (cell culture and expansion, bioreactor setup, transduction,
clarification, harvest, TFF), downstream (AKTAready, pilot, process using unicorn software, chromatography
methods, different columns like BPG, OPOS pre-packed, viral filtration).
• Reviewing and approving different quality control testing documentation like autoclave runs, bioburden,
endotoxin, filter integrity test runs, ddPCR, TCID50, conductivity, chromatography column efficiency, chemical
residues, EM summary reports etc.,
• Reviewing qualification and validation documents like Validation plan, Installation Qualification, Operational
Qualification, Performance Qualification and Test Method Validation’s for different equipment’s and process
operations (Bioreactors, incubators, freezers, PLC systems, AKTA, BSC’s, Vi-Cell, Gas testers etc.,)
• Performs On-the-Floor activities supporting client projects, including room release, vial issuance, auditing critical
processes, reviewing, documentation in real time, and resolving issues that occur during manufacturing.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to
internal procedures and industry best practices.
• Performing gap analysis, requirements gathering for projects with client and cross functional teams.
• Track and trend data on a weekly basis to update the project timeline, metrics and daily work.
• Detect coaching needs and take actions in accordance with these needs to ensure compliance with quality
standards.
• Elaborate the procedures of sampling and guidelines for collection and reporting quality data.
• Oversee the implementation and ensure efficiency of inspection and quality systems for continuous
improvements.
• Plan, perform and oversee inspection and testing of products to ensure the quality deliverable.
• Writing, reviewing, approving updating and redlining procedures following Good Documentation Practices
(GDP).
• Initiated and resolved non-conformance's, deviations and involved in CAPA activities using TrackWise.
• Reviewing, approving batch records and performing real-time review it the manufacturing operations and
supervisors supporting documentation for completeness, accuracy and compliance.
• Writing, reviewing, approving and handling Data Integrity Assessments, gap assessments, management, Data
Handling, Records Identification, Application configurations, etc.,
 • Reviewing and documenting electronic Audit trails, retention period, ERES, data backup and data recovery.

Abbott, Plano, TX Sep 2018 – Feb 2020

Sr. Manufacturing Engineer
• Responsible for part of remediation, FDA’s 483 warning letter and continuous Improvement projects following
FDA guidelines 21 CFR part 820, 210 and 211 for Cardiac and Neuromodulation (CM) products.
• Performing gap analysis for the cleaning process validations for the different product lines per ISO 13485 and
14971 standards.
• Written, reviewed, updated and redlined procedures following Good Documentation Practices (GDP).
• Commissioning and Qualification (Validation) of existing, new equipment and process(s) related to
manufacturing, cleaning, sterilization and analytical equipment(s).
• Performed non-conformance (NCMR’s), CAPA activities related to cleaning and Test Method Validation(s).
• Performed EO and Gamma sterilization audits at the vendor location for dose auditing, B/F test, bioburden and
sterility testing as per ISO 11137 guidelines.
• Performed qualification (IQ/OQ/PQ’s) for clean rooms, incubators, refrigerators, autoclaves and ovens.
• Designed and developed cleaning procedures for new products and manufacturing equipment and provided
technical support to cleaning activities associated with the manufacturing process.
• Designed and supported the implementation, i.e., provides training, of cleaning strategies for product transfer
projects and product development projects.
• Investigated and conducted troubleshooting/root cause analysis of cleaning related incidents, deviations and
cleaning out of specification results for non-validated or under development cleaning procedures.
• Reviewed technical reports, toxicological risk assessment or biocompatibility evaluations based on the
requirements of ISO 10993-1, FDA or other regulatory agencies.
• Performed batch verification activities for product release for the sterilization non-conformances.
• Promoted the use of customer preferred techniques for continuous improvement such as Lean, Six-Sigma, Poka-
Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Analysis (PFMEA).
• Carried out supplier validation audits, with supplier support and supplier advanced product quality planning
(APQP).
• Worked with Engineering (Design and Manufacturing Engineers) team to define process parameters and criteria
to ensure supplier process capability is effective to meet product and process requirements.
• Performed TMV’s on weigh scales, leak test, rulers, multimeter and other analytical methods like Biomek liquid
handlers, Liquid particle counters, Densitometers etc., per internal guidelines and NIST standards.
• Reviewed qualification documents for analytical instruments such has Microscopes, HPLC (Dionex ICS 5000+),
Spectrophotometer’s, Karl Fisher’s, ICE’s, etc., by gathering the Business Requirements in GMP-regulated
environment.
• Performed quality review (desk audit) of all qualification documentation including URS, FRS, FAT and IOQ’s.
• Performing Data Integrity Assessments of the Analytical lab/R&D equipment for System ER, ES management,
Data Handling, Records Identification, Application configurations, etc.,

Zimmer Biomet, Warsaw, IN May 2017 – Aug 2018

Sr. Process Quality Engineer
• Conducted remediation activities on addressing FDA’s 483 warning letter, Prospective, Concurrent and
Retrospective Validation(s) following 21 CFR part 820 Quality System Regulations and 21 CFR Part 11 Electronic
Records and Electronic Signatures for orthopedic reconstructive products; sports medicine, biologics, extremities
and trauma products.
• performed desk audits for the remediation of Validation Master Plan (VMP) related to Production & Process
Control) for the client location and doing annual requalification’s related to legacy validations and current
validations related to cleaning, packaging, Clean rooms, sterilization, molding processes, etc.,
• Worked in the validation of the new SCADAs infrastructure for the Ortho Biologics Bioreactors.
• Supported and executed tasks pertaining to systemic Process Validation CAPA’s and FDA observation’s
corrective action projects.
• Written, reviewed and approved SOP’s, work instructions, forms and memos in a change management software
(CMS).
 • Reviewed and approved MVP, IQ, OQ, PQ and TMV’s for different process validations related Lactosorb molding,
UHWMPE (ArCom vessels), injection molding, Shot peen, viscometer, powder filling machines, polishing lathes,
sealers, etc., on Info PV validation tool and paper documents.
• Qualified facilities equipment’s: HVAC and water systems during the upgrade process and configured control
systems.
• Involved in reviewing, writing and execution of test scripts and requirements specification verification
documents (RSVs) based on SDLC and GRC methodologies respectively.
• Implemented risk-based approach for the GxP computerized systems by performing gap analysis during the
transfer for data for manual operation to electronic systems (ERP) using GAMP®5 and ICH Q9 guidelines.
• Conducted Ethylene Oxide (EO) sterilization process validations to sterilize orthopedic implants and work with
contract vendors to the author and execute protocols to perform sublethal studies, half cycles, full cycles, EO
residual evaluations, and bioburden evaluations.
• Written and executed IQ, OQ, and PQ protocols for Belco Cavity Sealers utilized in the cleanroom Packaging.
• As a part of Data Integrity (DI) assessment, verified changes to sets of input data that are stored on the
equipment (e.g., recipes, methods) are performed only via change control and only by authorized users or are
formally checked before the execution of the process.
• Assisted the Cleaning team in analysis of swab and rinse samples and use of TOC analyzer for CIP, SIP, TFF and
COP skids.

United Pharma Technologies Inc, Iselin, NJ May 2017 – May 2017

Validation Engineer
• Designed and developed a product life cycle to develop complaint development approach for different family
products.
• Incorporated risk management activities to optimize design control for different streams like DoE, Design by
Quality, gage R&R activities and major review for each design phase.
• validated and verified quality practices and methodologies to analyze the direct impact on the process and
product design like reliability tests, worst-case analysis and performance tests managed validation and re-
validation.
• Performed desk audits to identify the gaps in the existing qualification documents.
• Developed Detailed Risk Assessment documentation for managing the risk levels used before the validation of
the system.
• Worked with cross functional teams to assess and close audit gaps, ensuring that the product labeling processes
comply with Good Manufacturing Practices (GMP).
• Written Standard Operating Procedures (SOP's) Process validations, ES, PM, IQ’s for manufacturing
equipment/facility equipment and provided consultation and ensured timely completion of effective CAPA.
• Designed and created large flow charts and other graphics to illustrate complex processes, initiatives, and
concepts to the manufacturing process (MS Visio).

University of Houston Clear Lake, Houston, TX Jun 2015 – Dec 2016

Research Associate
• Studied kinetics of ZIP transporters in a model plant Medicago truncatula to maintain Fe and Zn homeostasis.
• Prepared materials for reports, presentations, and submission to peer-reviewed journal publications.
• Set up, adjust, calibrate, clean, maintain, and troubleshoot laboratory equipment.
• Performed QC on the reagents, protocol optimization, analyzed experimental data and interpretation, statistical,
qualitative and quantitative analysis.
• Isolated/quantified plasmid DNA, RNA, and Protein from plants, prokaryotes, eukaryotes, and mammalian cell
cultures and use of PCR and Next Generation Sequencing Techniques.
• Prepared Competent cells & Bacterial culturing/Transformation using Restriction Sequence Ligation,
CRISPR/CAS9, immunoassay and bioassay analytical techniques (LC-MS, GC-MS, HPLC, etc.,)
• Calibrated analytical laboratory equipment such as HPLC and GC for accuracy, detection limits, noise level,
• precision, reproducibility, repeatability and robustness.
Virchow Biotech Pvt Ltd, India Apr 2014 – Dec 2014
Research Executive
• Planned, organized and conducted research experiments to develop a liquid / semisolid dosage forms, biologics,
and cellular therapy products.
• Performed pre-formulation studies, planning & performing bench scale batches & stability studies for products
under development using filtration systems, Quality checks, viability checks, tanks, bioreactors, and production
lines.
• Validated and maintained ERP automation software for the Production and Process control system software,
MES, production optimization (MPC, APC, control loop etc.,) for performing the operations.
• Coordinated, follow-ups and working in a team with Analytical Development Laboratory, Production, QA/QC
dept, CAPA, deviation assessments and sterility assessments.
• Performed commissioning and qualification (IQ, OQ, PQ) activities.
• Performed cell-based assays across multiple assay platforms (e.g.: flow cytometry, ELISA, RT-PCR, luminescence,
Southern blot, Western Blot, Liquid chromatography techniques, etc.,)
• Validated, performed QC activities for the computer systems including but not limited to HPLC, LC-MS, GC-MS,
ICP etc.,
• Verified data integrity and accuracy, formulation Development of dosage forms like Immediate and modified
release tablets and capsules, semisolids, and liquids using Quality by Design Concept.
• Successful scale-up, troubleshoot, solve difficult problems, developed assay improvements, maintained careful
laboratory notebook record-keeping and performed different SAP Activities related validation and transfer
projects.

Virchow Biotech Pvt Ltd, India Apr 2013 – Apr 2014

Research Assistant - Project Intern
Project: Downstream processing of Recombinant human Granulocyte Colony Stimulating Factor (rh G-CSF) V66 of E-coli.
• Protein expression in E-coli (cloning, screening, plasmid extraction/isolation, Restriction digestion, ligation,
transformation, culture growth for protein expression, Gel electrophoresis and test result analysis).
• Protein purification: Sample collection from fermentation batches (Bioreactors), centrifugation, pH monitoring,
solubilization of Inclusion bodies, CTU monitoring, maintaining lab notebook, data integrity, autoclaves,
incubators, freezers, ultra-centrifuge, UV spectrophotometer, Nanodrop, Cation-Exchange Column
Chromatography, UPLC, Flow Cytometry, and Gel Electrophoresis and Western Blot.
• Copied, logged and scanned supporting documentation, implementing marketing strategies which resulted in
12% growth of customer base.
• Performed Molecular Biology techniques like Extraction of DNA and RNA from mammalian cells, RE digestion of
plasmid DNA, Gel electrophoresis, DNA cloning, ligation of DNA into vectors, qPCR, microscopy, etc.,
• Prepared formula by literature search and taking trials of laboratory batches, animal study, and maintenance,
conducted pre-formulation & stability studies, development in-vivo and in-vitro experiments in the research
laboratory for new/existing products.

Dr. Reddy’s Laboratories, India Apr 2012 – Apr 2013

Manufacturing Process Engineer (Intern)
• Responsible for product disposition, complaint handling, root cause investigations, identifying and implementing
process improvements, and functioning as a Quality Management System (QMS) expert.
• Ensured product acceptance by conducting part qualifications, specification sampling plan development.
• Executed test cases for different process and packaging equipment’s, lyophilizers, freezers, bioreactors,
autoclaves, Spectrophotometers, Chromatography analytical equipment, thermocouples, viscosity meters,
dimensional gages etc.,
• Responsible for writing test scripts to ensure that reports generated on chromatography (HPLC) results
integrating with IDM LIMS Link are in compliance with cGLP and 21 CFR Part11.
• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21
CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and
session time-out for the manufacturing systems.
 • Using statistical tools, identified process and product risks, and developed mitigation activities via root cause
analysis and corrective actions.
• Performed trending of Data and Trending Meeting, SME - Gather, review and send data for monthly trending
meeting.

EDUCATION:
• M.S in Project Management, University of Cumberlands, Williamsburg, KY
• M.S in Biotechnology, University of Houston Clear Lake, Houston, TX
• B.S in Biotechnology, GITAM University, India