Sai Snith Chittampally

· Review all GMP documentation, such as SOPs, investigations, deviations, quality events, QC testing, study reports, validation/qualification protocols, and summary reports.

· Review Out of Specification results, trending data, critical impact deviations, and lower impact quality events.

· Review the CAPA records and conduct quality assessment checks.Planned and executed follow-up audits at appropriate intervals.

· Monitoring and managing the timelines for Deviations and Investigations, and coordinating with the Quality Control team to initiate extensions if necessary.

· Specializing in training new employees in investigative processes and techniques.

· Conducts GLP training for testing laboratory staff.

· SME for Root cause analysis tools, (TapRoot).

· With supervision, manages responses to clients regarding investigations, deviations, atypical chromatography, etc.

· Carries out additional relevant responsibilities to fulfill business requirements.

· Method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds were performed independently across various formulations and delivery systems.

· Validated test methods to confirm their accuracy, precision, and reproducibility, ensuring that the methods met regulatory requirements and industry best practices, and could be reliably used for product testing and quality control.

· Troubleshot and resolved issues with chromatography equipment (HPLC, UPLC) to ensure smooth operations and reliable data.

· Independently performed various types of testing like SoloVPE, CEX, CE (Reduced and non-Reduced), RP, ELISA, SEC, Glycans extraction etc. on HPLC, UPLC, CE, ICE (PRINCE), Solo instruments.

· Performed Enzyme-Linked Immunosorbent Assay (ELISA) testing and applied aseptic techniques to ensure precise and reliable experimental results.

· Followed standard operating procedures (SOPs) and protocols while generating detailed reports to document testing processes, deviations, and corrective actions.

· Involved in assisting QA director, Quality assurance to perform quality assurance activities such as Authors SOPs and Method of analysis documents, reviewing and controlling GMP documentation.

· Prepared study protocols, project status reports, final study reports and other project-related technical documents.

· Reviewed documentation such as routine and non-routine analysis, COA and cumulative reports, deviation and investigation records and SOPs as required.

· Developed and implemented templates for validation protocols and summary reports.

· Audited internally and addressed area/departments with compliance issues and training needs if necessary.

· Handled deviation records and ensured CAPA implementation and ensuring GMP compliance for drug products with regulatory requirements.

· Implemented Corrective and Preventive Actions (CAPAs) to address non-conformances and deviations, ensuring that quality issues were resolved, and processes were optimized to prevent recurrence and enhance overall compliance with regulatory standards.

· Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.

· Ensured QA findings are addressed appropriately.

· Communicated project status to project leader.

· Communicated data and technical issues to the client and responded to client needs and questions.

· Mentored, trained, and coordinated laboratory activities of other team members and assisted in troubleshooting instruments and analytical problems.

· Reviewed, interpreted, and analyzed data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP)

· Performed self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

· Scientifically analyzed and tested Raw materials, in process, finished product and stability samples using modern quality control techniques like UV-Vis, IR, X-ray Diffraction etc. under close supervision of senior chemists/ scientists.

· Worked with advanced analytical equipments like HPLC, GC, UV, KF and FTIR and applied knowledge of broad variety of quality control and analytical techniques.

· Validated and analyzed results as per USP, BP, EP, ICH and USFDA.

· Assisted scientists and worked under supervision to develop, implement, and maintain quality control systems and activities. This involved collecting and researching scientific data/reports, as well as recording scientific evidence/results from laboratory and developmental activities.

· Compiled data for documentation of test procedures and prepared reports.

· Calibrated/Verified critical laboratory equipment and instrumentation and assisted in drafting/updating inspection procedures and checklists as necessary.

· Performed in process inspection, document results, and performed wide variety of inspections, checks, tests, and sampling procedures for manufacturing process while working as a part of group of chemists/ scientists under close guidance/supervision from experienced chemists/scientists.

· Followed guidance from experienced chemists/scientist and assist them in developing and implementing validation protocols and test procedures by performing lab experiments, chemical analysis of materials, preparing test solutions conducting QC tests etc. to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and industry current practices.

· Approximately 85% of time was spent analyzing raw materials, in process, finished products and stability product samples and validating results using modern quality control and analytical methods. Approximately 15% of the time was spent in preparing reports, documents and conferring/ interacting with scientists and maintaining ICH guidelines and US FDA regulations.

· Ensured most of the reports received from the clinical trials or post marketing are identified and reported as per ICH guidelines.

· Triage reports based on seriousness and effectiveness of the drug product.

· Communicated with medical affairs department to access case reports.

· Coding of medical history, adverse events, drugs, procedures, indications, and laboratory tests using company Core Data, MEDRA and WHO dictionaries.

· Writing case narratives for serious/non-serious and clinical reports.

· Analyzed DE challenge and RE challenge.

· Generated queries using Argus interface clarification, resolving, and forwarding to network flow.

· Completed periodic safety update reports on drugs and treatments.

· Submitted periodic reports to Food Drug Administration.

· Migrated data from Pfizer database to Shire clinical database.

· Executed field to field transfer from ARISG database to ARGUS database.

· Reviewed and evaluated AE case information to determine required action based on the reports following internal and procedures.

· Ensured most of the reports received from the clinical trials or post marketing are identified and reported as per ICH guidelines.

· Triage reports based on seriousness and effectiveness of the drug product.

· Communicated with medical affairs department to access case reports.

· Coding of medical history, adverse events, drugs, procedures, indications, and laboratory tests using company Core Data, MEDRA and WHO dictionaries.

· Writing case narratives for serious/non-serious and clinical reports.

· Analyzed DE challenge and RE challenge.

· Generated queries using Argus interface clarification, resolving, and forwarding to network flow.

· Completed periodic safety update reports on drugs and treatments.

· Submitted periodic reports to Food Drug Administration.

· Migrated data from Pfizer database to Shire clinical database.

· Executed field to field transfer from ARISG database to ARGUS database.

· Reviewed and evaluated AE case information to determine required action based on the reports following internal and procedures.