Anish John

• Developed investigation strategies in collaboration with manufacturing and quality operations. • Conducted root cause analysis and implemented CAPAs to address compliance issues. • Acted as a delegate for the production manager, ensuring smooth departmental operations. • GMP Documentation review (BPRs, logbooks, etc.). • Triennial Updates of procedures.

• Reduced document review turnaround times and implemented SOP changes based on CAPA findings. • Provided cGMP and on the job training to new hires. • Successfully reduced the document review time turnaround - Executed BPRs and logbooks. • Provided justification, impact, and risk assessment for change controls. • Assist in Deviation Investigation, CAPA implementation and Effectiveness Check • Responsible for providing cGMP, GDP, and technical training to new hires. • Performed concentration and diafiltration by using TFF system.

• Coordinate with Manufacturing, Project Management and client to ensure the updates required for Batch Production Records and discussed through relevant documentation history • Implement changes to controlled GMP documents (change control) • Initiating change requests, developing training modules required to implement corrective and preventive actions as a result of deviations and client needs • Investigate deviations, determining root cause and recommending necessary corrective and preventive actions • Owning the generation of all BPRs, SOPS, forms, MCCPs and equipment logbooks associated with the manufacturing of an internal as well as client product line (technical writing) • Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales. • Reviewing BPRs and logbooks for correctness and completions.

• Audited a production plant for GMP compliance and wrote audit report • Audited Batch Production records for good documentation practices and GMP compliance • Wrote SOPs for the operation and cleaning of various pharmaceutical analytical equipment • Have used the USP for in process testing of tablets e.g., dissolution, disintegration, friability, hardness, uniformity of dosage units • Proficient in the use of the HPLC system, UV spectrophotometer, analytical balanced, pH meter and other QC lab equipment • Produced and maintained lab records

Performed analytical testing of Albumin and Immunoglobulin efficiently and accurately to comply with market release. Reviewed quality documents, reported results in SAP and prepared COA for release. Handled Change Control, Deviations, OOS and CAPA. Wrote and revised SOPs, STPs and other controlled documents. Estimated protein for in-process test samples, drug substances, drug product and stability samples by OD280, Biuret, Bradford and Kjeldahl Processed HP-SEC analysis of different in-process test samples, drug substances, drug product and stability samples Performed ELISA and Real Time PCR testing for the presence of HIV, HCV and HBV antigens Performed Calibration and Qualification of instruments

RP-HPLC, HP-SEC, Peptide Mapping and Ion Exchange Chromatography analysis of different test samples. SDS-PAGE and Iso-electric Focusing analysis of different test samples by Silver Staining, Coomassie Staining and Western Blot. Estimation of protein for different test samples by OD280,Bradford and Lowry. Preparation of STPs, Specifications and Method Validation Protocols. Development of Internal Reference Standards.

Commercial scale production of Downstream of rabies vaccines. Concentration of Raw Virus Harvest on Zonal ultra centrifuge. Sterilization operation of Zonal Ultra centrifuge Concentration of Rabies virus harvest Virus inactivation by using beta propiolactone and blending of rabies vaccine. Final Formuation of rabies vaccine. To prepare Working Seed Virus.