Venkatareddy Pothireddy

+1-267-***-****

adv5mo@r.postjobfree.com

Work Authorization: H1b (Visa till 02/15/2025)

Required I-140 filing

Well experienced Quality Engineer with expertise in Quality assurance, change control, Quality control, Supplier change management, Corrective Action/Preventive Action (CAPA), Out of Specifications (OOS), deviations, validation and technical documentation within pharmaceutical industry.

Demonstrated knowledge of quality function and fundamentals of compliance, auditing processes.

Expertise in Medical device and FDA regulations, Advanced Quality tools including GD&T, Failure Mode Effective Analysis (FMEA) and Root Cause Analysis.

Experienced with cGxP, FDA, QSR ISO 13485, 21 CFR Part 11, 210, 820.

Good Knowledge of product development life cycle, Gap Analysis, Trace Matrix, Gage R&R and Validation Protocols (IQ’s, PQ’s, OQ’s), Laboratory Equipment, Analytical Instruments.

Good experience with Acceptance sampling, Root-cause, corrective action investigations.

Experience in developing/maintaining Test Plan, Validation Plan, Quality Management Systems (QMS), User requirement specification, Remediation Summary report.

Working knowledge of Word, Excel, Minitab, PowerPoint LIMS, SAP, Track wise, Master Control, DMS and Veeva and other data management applications.

Work Experience:

August Bioservices, Nashville, TN Nov 2022 to Till Date

Principal Quality Assurance Investigator

Ensured timely completion of investigations/CAPA/Events/Product Complaints/ Action items.

Coordinated immediate actions in conjunction with QA and cross functional department management upon identification of a non-conformance.

Interviewed the Subject Matter Experts (SMEs) and involved employee(s) across multiple shifts to investigate reported problems and assess the quality impact.

Conducted to investigational meetings with required team member(s) to identify the root cause.

Verified Investigational findings against documented process per SOP.

Utilized problem solving techniques & tools to determine root cause, appropriate causal factors.

Worked with cross functional team member(s) to develop appropriate CAPA actions.

Performed technical write up for investigation reports with minimal guidance.

Ensured investigations, corrections and CAPA are generated and closed out in a timely manner.

Identified and analyzed trends arising from individual investigations.

Supported/coordinated data collection required for management reviews, KPI reports, client trend review meetings, and all other established regular quality reporting and review mechanisms.

Acted as liaison as it relates to specific investigations during client calls and audits.

Reported the performance of the quality system as a basis for improvement of the quality system

Facilitated root cause analysis meetings with key stakeholders to identify solutions for quality improvements based on identified trends.

Managed, conducted/coordinated, tracking, and followed-up of activities related to trend CAPA’s.

Coordinated the review of trend CAPA’s to determine their effectiveness.

Supported/performed tasks within other QA departmental disciplines including but limited to audits and process improvements as assigned by management.

Calculated Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas & personnel.

Provided guidance and training to other personnel/new hires in the Investigation/CAPA group.

Managed CAPAs to ensure timely closure of actions resulting from various types of investigations.

Provided metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.

Managed the Effective Checks to ensure they are completed by the required due date.

Prepared Monthly updates on Quality metrics.

Conducted the Investigations Review Board and discuss critical investigations with corporate team.

Conducted daily meetings with Cross Functional Team to close investigations on time.

Performing Product and Process Trending, author for reports and presenting at management review meetings.

Performing trending of all environmental monitoring and process utility data author quarterly reports and escalate any issues or adverse trends to Senior Management.

Calculate Contamination Recovery Rates (CRRs) for all Graded Manufacturing areas and personnel.

Performing Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management

Leading the Alarm Reconciliation Program ensuring all facility Critical alarms generated are accounted for and proper root cause, corrective action, event assessment and trending is complete and accurate.

Updating Quality Assurance standard operating procedures as required

Performing the Gap assessments of corporate standards and guidance documents where required.

Akorn Inc., New Jersey, June-2021 to Nov 2022

Quality Assurance Senior Investigator

Oversaw and assisted with laboratory investigations to ensure compliance with FDA.

Worked with management to review and analyze investigations to assure that all non-conformances are adequately investigated for determination of root cause & corrective preventive actions are identified and implemented to prevent/reduce excursions in processes and procedures.

Coordinated, Wrote, and Reviewed laboratory investigations including but not limited to non-conformance, deviations, out of specification and out of trend results.

Performed laboratory investigations, including hypothesis testing, root cause analysis, trending, risk and impact assessments.

Experience with QC analytical techniques, troubleshooting, Method Validations Using root cause techniques, assist the quality control and operations teams in and / or perform Deviation, Non-Laboratory OOS, OOS, OOT, field complaint and event excursion root cause determination and effective preventative action implementation.

Reviewed pending investigations for timeliness and work with investigators to ensure progress is made on outstanding investigations.

Planned and directed work for laboratory investigations Maintaining confidentiality of information.

Tracked all Non-Conformance/Deviation records to ensure the timely closure of all records.

Followed up with the Assigned To’s as needed for status and to ensure support is available to ensure completion by the due date.

Perform Gap assessments of corporate standards and guidance documents.

Provided SME support on the use of the Akorn TrackWise workflows to end users as needed.

Provided guidance to Assigned To’s of investigations on performing investigations and in the use of Root Cause Analysis Tools.

Provide guidance and training to other personnel/new hires in the Investigation/CAPA group.

Managed CAPAs to ensure timely closure of actions resulting from various types of investigations.

Provided metrics as requested to track/trend Non-Conformances, Deviations, and CAPAs.

Acted as the Investigation lead for minor Non-Conformance/Deviations investigations as needed.

Performed the closure of Effectiveness Checks.

Managed the Effective Checks to ensure they are completed by the required due date.

Provided Monthly updates on Quality metrics. Conducted the IRB and discuss critical investigations with corporate team and daily meetings with CFT to close investigations on time.

Performing other Quality related tasks such as deviation investigations and GEMBA assessments when required

Participating in process improvements programs when required.

KVK Tech Inc., PA Jan-2019 to June-2021

Quality Assurance Engineer

Involved in direct activities like raw material, in-process, finished product and stability testing. covering all phases of the product life cycle from GLP/GMP testing of materials for clinical trials and commercial testing.

Created batch record reports based on user requirements. Reviewed and released batch records for multiple-production lines, ensuring regulatory compliance, and timely release of batches.

Provided quality assurance expertise for quality, quality issues to ensure compliance and quality, in line with corporate policy and procedure, GAMP, and GxP methodology for regulated quality laboratory, manufacturing, and clinical environments.

Independently performed Quality Assurance walkthroughs of classified manufacturing areas to observe and evaluate production activities, aseptic processes and the proper execution of Batch Production steps, identify any deficiencies and escalate critical issue to Senior Management

Reviewed and approved analytical documents, analytical instruments IQ/OQ/PQ documents, investigations reports (OOS/OOT), SOP/STP/GTP.

Approved and released Finished Product Certificate of Analysis (COA).

Initiation and closing of Change Controls. Initiated/Wrote Quality control investigations.

Performed Tracking and Trending of OOS/OOT/Change Control.

Audited trials verification in Empower software. Reviewed and approved Calibration documents.

Approved Standard Operating Procedures related to Quality Control.

Ensured all the documentation practices being followed in QC Laboratory in line with GDP.

Ensured all the QC Equipment/ Instruments are Qualified and maintained as per the Master Schedules of Calibration, Periodic Requalification and Preventive Maintenance.

Performing the Gap assessments of corporate standards and guidance documents where required.

Pfizer Health Care, India Feb-2013 to Jan -2019

Quality Assurance Asst. Manager

Developed methodologies and maintained standards for quality assurance, change control and project management guidelines within the regulated, company quality environment.

Maintained records and clean-room environment to comply with regulatory requirements, good manufacturing practices and aseptic processing of clinical and commercial products using SOP’s.

Implemented deviations, root cause analysis and Corrective and Preventive Actions (CAPA) to remove production constraints and improve product quality (TrackWise).

Develop, review, and approve analytical method validation protocols, method transfer, reports, stability protocols, stability data, process validation protocol, specifications, and test methods.

Review raw data and report related to in-process and product release, OOS investigations and qualification of process changes.

Ensure that analyses of experimental and stability samples are conducted strictly in accordance with cGMPs, company's SOPs and protocols.

Updated, Tracked, and implemented Compendial changes. Planned, Reviewed and Monitored Analytical Review Group. Coordinated during External Audits.

Performed Laboratory Walkthroughs and Supported Laboratory Investigations (LIR/Track wise).

Escalated critical observations to the Management.

Assessed Compendial Changes and changes in Corporate Procedures.

Approved Specifications, Standard Test Procedures, Tracked Invalid Data Events/ LIR/Exceptions.

Authorized Finished Product COAs. Prepared SQMR related to Quality Control.

Worked on Final Certification of Analytical Method Verification/Validation/Transfer related Protocols and Final Certification of Instruments/ Equipment Qualification Protocols.

Approved SOPs related to Quality Control. Impacted Assessment for Change Controls.

Ensured all Quality Control Procedures like Standard Operating Procedures, Testing Procedures, and Preventive Maintenance Procedures are in place and are being followed.

Ensured all the QC Equipment/ Instruments are Qualified and maintained as per the Master Schedules of Calibration, Periodic Requalification and Preventive Maintenance.

Ensured all the QC Personnel performing analysis are qualified on all the relevant Analytical Techniques and review of Analyst Qualifications.

Ensured the analysis being carried out in the QC Laboratory in line with the approved procedures.

Ensured all the documentation practices being followed in QC Laboratory in line with GDP.

Aurobindo Pharma Limited, India, Dec-2008 to Feb-2013

Sr. Executive in Quality Control

Conducted quality control testing review of raw material and pharmaceutical dosage forms for release and stability testing. Analyzed and reviewed QC test results.

Interacted with cross functional groups within the organization including Quality Control, Analytical Technology/Development, Quality Assurance, Regulatory and Manufacturing/Operations.

Conducted quality control testing and data review for release of pharmaceutical raw materials (bulk drug and excipients) as well as primary and secondary packaging components.

Reviewed Analytical Documents in Quality Control Laboratory.

Analyzed Finished Products/ In- process samples, Maintained documents per cGMP requirement.

Trained Chemist in SOPs, GTPs. Systems etc.

Ensured Compliance of various quality measures such as GLP and GDP, by maintenance of appropriate requisite documentation/ records.

Calibrated instruments like HPLC, UV, Dissolution Apparatus, KF Titrator, Friabilator, Tablet Hardness Tester, and Disintegration Tester. Reported analytical observations in Lab Ware LIMS.

Hetero Drugs LTD, India, May 2006 - Nov 2008

Senior Executive, Analytical R&D

Analyzed of AR&D Samples

Calibrations of instruments like HPLC, UV, Dissolution Apparatus, KF Titrator, Friabilator, Tablet Hardness Tester, and Disintegration Tester.

Ensured compliance of various quality measures such as GLP and GDP, by maintenance of appropriate requisite documentation/ records. Reported analytical observations in Lab Ware LIMS.

Education

M.Sc. (Biotechnology) from Bharathidasan University, India.

B.Sc. (M.B.C), from Acharya Nagarjuna University, India.

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