Quality Control Assurance

PRAVEEN REDDY GALIGUTTE

Email: ad1s3a@r.postjobfree.com

**** ********* *****

Delmar, MD,PH:443-***-****

SUMMARY

Diversified analytical support experience in analytical research, Quality Control in pharmaceutical development and in Environmental Sciences. Expert in analytical cGMP equipment and procedures. Effectively manage projects through various phases of analytical research and development to meet quality assurance and regulatory requirements. Supported a wide range of projects from raw materials to finished packaged products. Proven skills in analytical science support for method development, method validation, method transfer and testing. Efficient documentation of experiments and test results in appropriate lab manuals, electronic software and company records.

PROFESSIONAL EXPERIENCE

DNREC (Delaware Natural Resources and Environmental Control Agency) Oct 2016 – Present

Sr Analytical Chemist(Lead/Supervisor)

Development of new entities for contaminants by HPLC, HPLC-MS,ICPMS, GCMS, GC(ECD), TOC, IC, DI water system also working with EPA, FDA Methods for VOA,SVOA and other Pharmacopeias.

IQOQPQ, Calibrations, Validations of Laboratory equipment’s (Major, Minor) HPLC’s (Waters, Agilent), UPLC(Waters), UV(Shimadzu, Perkin Elmer, Agilent), Malvern PSD, FTIR(Perkin Elmer), TOC(GE), GC(Agilent), GCMS(Agilent), ICPMS(Agilent), Millipore DI water system for Compliance. If not inform the management and suggested for appropriate actions need to be taken.

Metrology and calibration repairs scheduling with contactors for laboratory equipment’s .

Timely release of the results to the project clients as per the TAT and get the customer feedback.

Planning and Managing of projects for timely releasing of the projects as per the TAT.

Training to the chemists on new methodologies and Methods as per the in-house development or regulatory norms.

Installation of new equipment’s, decommissioning the old or retired equipment as per company policies in the laboratory.

Scheduling contractors for preventive maintenance and repairs as per the schedule and when needed

Investigate equipment failures and noncompliance and taken corrective action and Preventive Action if necessary (CAPA).

Granules Pharmaceuticals Inc Jan 2016 – Oct 2016

Sr.Chemist / Supervisor Analytical and Quality Control(Contract)

Metrology, equipment IQOQPQ, Calibrations, Validations of Laboratory equipment’s (Major, Minor) stability chambers, Dissolutions(Distek,Varian), HPLC’s (Waters, Agilent), UPLC(Waters), UV(Shimadzu, Perkin elmer, Agilent), Malvern PSD, FTIR(Perkin Elmer), TOC(GE), GC(Agilent), GCMS(Agilent), ICPMS(Agilent), Millipore DI water system for Compliance. If not inform the management and suggested for appropriate actions need to be taken.

Installation of new equipment’s, decommissioning the old or retired equipment as per company policies in the laboratory.

Scheduling contractors for preventive maintenance and repairs as per the schedule and when needed

Investigate equipment failures and noncompliance and taken corrective action and Preventive Action if necessary (CAPA).

Coordinated the analytical and microbiological activities for the successful launch and continuous release testing of 2 commercial products.

Managed the daily work activities of the analytical and microbiological personnel

Coordinated the analytical activities including testing for release and stability of raw materials, finished products and repackaged products

Provided coaching for new colleagues in various testing techniques, and explained various aspects in detail to ensure that each trainee was able to independently conduct the testing successfully.

Performed activities which include generating and executing protocol for calibration of equipment and maintain up to date calibrated equipment

Performed method development, evaluation, transfer and validation for support of analytical methods for support of manufactured products.

Trained chemist / Students frsh from college on Analytical techniques like HPLC, UPLC, GC, ICPMS, GC-MS, LC-MS, Malvern, DSC, Wet chemistry, Documentation for Trainee and also new joining as per company policies.

Investigate OOS and OOT results and take corrective action and Preventive Action if necessary (CAPA). Specialised in Trackwise software for CAPA, Deviations, Change controls for QC/QA.

Review QC/QA Data for Product release prepare COA for Raw material, Finished dosages and release .

Jubilant Cadista Pharmaceuticals Inc May 2008 – Jan 2016

Sr.Chemist / Supervisor Analytical and Quality Control

Provided analytical chemistry support for testing, validation, transfer, method development and documenting test results in company records.

Investigate OOS and OOT results and take corrective action and Preventive Action if necessary (CAPA). Specialised in Trackwise software for CAPA, Deviations, Change controls for QC/QA.

Review QC/QA Data for Product release prepare COA for Raw material, Finished dosages and release in SAP sytem and Inhouse.

Coordinate with QA, Metrology, Validation group for equipment IQOQPQ, Calibrations, Validations of Laboratory equipments (Major, Minor) stability chambers for Compliance. If not inform the management and suggested for appropriate actions need to be taken.

Coordinate with QA / Purchase / Planning for timely release of products as per schedule with compliance.

Managing 8 Chemists and 3 technicians for timely release of raw material and finished solid Dosages according to Regulatory Norms and condition.

Trained chemist on Analytical techniques like HPLC, UPLC, GC, ICPMS, Malvern, DSC, Wet chemistry, Documentation for Trainee and also new joining as per company policies.

Provided high quality analytical support and effective documentation in company manuals for several projects with over 95% accuracy with less deviations from the lab.

Performed over 50 tests monthly for several samples and projects, including Assay, Content Uniformity, Related Substances, Blend Uniformity and Dissolution.

Performed testing on finished product, per protocol, for validation of manufacturing processes, including tests for blend uniformity, cleaning validation and assay.

Provided clear, concise and well-organized documentation in company records for communication and problem solving in order to transfer knowledge and understanding of activities.

Troubleshoot and render solutions for analysis and instrument issues which included supporting 1st shift colleagues for setup analysis and quick assessment for instrument failures for least downtime.

Managing the stability protocols and timely analyzing the samples according to the SOPS and procedure for submission batches.

Method Development and method validation of Submission batches.

Comparison of R&D products to innovator products.

Jubilant Cadista Pharmaceuticals Inc Jan 2004 - May 2008

Chemist III / Method Development Scientist-III

Proven skills for method development, method transfer, validation, and interaction with pharmaceutical clients to meet clients’ needs for analytical support campaigns at Jubilant Cadista Pharmaceuticals, MD cGMP Plant from R&D trials to Submission Batches.

Developed and optimized various HPLC and GC methods from pharmaceutical clients to support API and Finished products campaigns for delivery of batches to clients.

Transferred knowledge and trained QC peers on developed methods to support the 3 shifts for analytical support of products manufactured in the plant

Performed method validation for analytical HPLC,GC, Malvern PSD methods for client to support release testing of manufactured products outsourced to Jubilant Cadista Pharmaceuticals.

Authored methods, validation protocols and executed protocols in an efficient manner to achieve various timelines

Reviewed data for peers for support of analytical testing for active pharmaceutical and Finished products from clients to ensure data is complete with no errors and sound for its purpose.

Dr. Reddy’s Laboratories Ltd, Hyderabad.(API Plant,Solids, Semi Solids) 1999 - 2004 AR&D/ Quality assurance Officer

Working and executing new projects related to API s technology transferring from one plant to another and from R&D to plant Executing the project in timely manner for regulatory compliance

Performed Vendor Audits for Raw materials and other key sources and INVESTIGATE Customer complaints and prepare responses and take proper action.

Developing Process validation protocols relating to API s and execution in a timely manner and supporting and coordinating with Quality control in timely execution for regulatory requirements and compliance

Aurobindho Pharma Ltd, Hyderabad (API Plant) 1998-1999 Production Officer

Responsible for timely productions of API and maintaining BPRS according to DMF, EDMF, TGA, other regulatory requirements

TECHNICAL SKILLS (SME)

Analytical instrumentation: HPLC, GC, uPLC, LC-MS, SFC, Karl-Fischer, FT-IR, Optical Rotation, Dissolution, Disintegration, standalone UV-VIS, PXRD, DSC, ICP-MS, XRF, compendia methods and USP’s wet chemistry methods

Software: Waters Empower, Symyx electronic notebook, LabWare LIMS, Turbochrom, Agilent ChemStation, Trackwise QCS, PeopleSoft, Minitab.

EDUCATION

Masters in Chemistry, Andhra University, India 1998

B.S in Chemistry, Andhra University, India 1996

Contact this candidate