Swaroop Potdar Email & Phone Number

New Delhi, Delhi, India

*Proficient in ensuring compliance with relevant regulatory requirements, such as Good Manufacturing Practices (GMPs), ISO 13485:2016, ISO 9001:2015, ISO 11133:2014, GMP, CE & IVDR guidelines. & also, have knowledge & experience with USFDA, MHRA, WHO audits, USP, EP, BP & other pharmaceutical guidelines.*Proven track record of developing & maintaining a robust quality management system, including standard operating procedures (SOPs), training programs, & documentation.*Excellent communicator with a strong ability to communicate the results of microbiological analyses & research to senior management, regulatory agencies, & other stakeholders.*Highly effective technical advisor with a proven track record of providing technical guidance & support to production & quality control teams.*Proficient in creating engaging & informative content to promote the company's microbiological expertise & products.*Experienced in handling the launch of new products, including demonstrations at customer sites as needed.In addition to the above, I have the following skills & experience:*Conducting internal audits, providing technical support for audits & inspections, & implementing corrective actions.*Outsourcing product testing to outside certified laboratories & reviewing their reports.*Training on microbiological best practices, troubleshooting, & resolving quality-related issues.*Developing & implementing microbiological testing procedures, protocols, & methods to ensure accurate & efficient testing processes.*Providing content & reviewing the creatives for social media posts & blogs on the company website.*Assisting in pre-sales & post-sales support to the sales & marketing teams in handling customer queries & complaints from domestic & international customers.*Providing product training to sales & marketing teams, ensuring their understanding of microbiological concepts & product features to effectively promote & sell the company's products.

Bengaluru, Karnataka, India

* As a primary responsibility, Handled a team of 14 analyst for Environmental monitoring for Parenteral Site.* Performed area, HVAC qualification and Pass box validations * Performed Identifications of isolates on Vitek, * Documents preparation,* Documentation Review, * Data-log review.* Handled QMS documentation which includes OOS, Incident and deviation.

Gurgaon, Haryana, India

Worked in QC department in Microbiology analyst as well as QC Analytics executive. In this role, I have performed the following tasks;* Establishment of Microbiology laboratory.* Microbial Testing of samples.* Sterility Testing.* Environmental monitoring.* Water analysis.* Media preparation.* Growth promotion testing.* Culture maintenance.* Review and maintain detailed logs and report of analysis performed.* HPLC analysis of therapeutic proteins.* HPLC Method Development and Validation.* Total protein Estimation using BCA, Bradford, and A280method.* SDS PAGE analysis and Western Blot Analysis.* Delivered individual products on recombinant protein A, Soybean Trypsin inhibitor, Vaccine development for SARS CoV-2 and other therapeutic proteins where performed QC testing, method development and method validations and Quantification tests.* Prepared trends for sample analysis for projects as per the batches.* Answered customer questions and resolve issues promptly.* Handled QMS related documentation which includes Incidents and deviations alongside QA.

Ahmedabad, Gujarat, India

As a QC Microbiologist worked For a Sterile facility including Injectables, Vaccine, Biotech, VLP, and OSD facility for following roles;* Environmental Monitoring* Area Qualification and validation* Media fill activity* Gowning qualification* Media preparation and decontamination* Sterility testing* Culture identification on VITEK 2* Trend analysis for environmental monitoring data and water analysis data

Goa

As a QC Microbiologist, performed following tasks as per my job role;* Performed Environmental monitoring in Sterile media preparation facility as well as whenever required in non sterile facilities in aerosol, topical and Tablet and capsule manufacturing facility.* Performed water sampling and microbial analysis for water along with performing sampling point validation.* Performed standard culture maintenance and culture preparation along with Identification of isolates from different samples.* Performed weighing balance calibrations and data log records for incubators and refrigerators.* Handled QMS related documentations like OOS, Incidents and deviations.* Prepared trends for environmental monitoring and water analysis.* Faced major audits like USFDA,MHRA, WHO, ANVISA, MOH of different countries and also internal audits.* Experienced with softwares like LIMS, Data logger IC-DAS.

Mumbai, Maharashtra, India

Worked as Flow cytometry Analyst and performed Western Blotting for HIV and Arthritis samples.

Master'S Degree, Applied Microbiology

Bachelor Of Science (B.Sc.), Microbiology