Regulatory Compliance Quality Assurance

KISHOR BHOGE

Sr.Associate II

Phone No: 988-***-**** Email Id: ******.*****@*****.*** Address: Ahmedabad, Gujarat, India DOB: 06-08-1983

Seasoned Microbiology professional, offering 17 years' expertise in pharmaceutical microbiology operations and regulatory compliance; seeking a Manager role to optimize laboratory processes and ensure cGMP adherence within innovative pharmaceutical environments. Aim to leverage extensive experience in sterility assurance and microbiological control to enhance product quality and audit readiness.

PROFESSIONAL SUMMARY

17 years of progressive experience in microbiology laboratory management within the pharmaceutical industry, specializing in sterility assurance, bioburden testing, and environmental monitoring. Proven ability to lead teams and manage microbiology operations, ensuring compliance with stringent regulatory standards, including USFDA, TGA, ANVISA, and WHO.

Expertise in developing and implementing contamination control strategies and streamlining processes in sterile manufacturing environments.

Adept at conducting EMPQ simulations, root cause investigations, and managing data integrity (ALCOA+) in alignment with cGMP and Annex 1.

Skilled in trending microbiological data using SPC techniques (I-charts, Pie charts, Pareto charts) to maintain manufacturing process control.

Subject Matter Expert (SME) for SKAN Make Isolator systems, with involvement in qualification and re-qualification activities. Experience in review and approval of critical quality documents including validation/qualification protocols, reports and summaries.

Proficient in using LIMS, Electronic Lab Notebooks, Maximo and Trackwise 8 for efficient data management and laboratory operations.

SKILLS

Technical Skills: Sterility Assurance, Bioburden Testing, Bacterial Endotoxin Testing, Environmental Monitoring, Microbial Trending, USFDA Compliance, cGMP, Annex 1, EMPQ, Root Cause Analysis Core Competencies: Quality Assurance, Regulatory Compliance, Laboratory Management, Process Optimization, Data Integrity Management

Soft Skills: Leadership, Communication, Problem-solving, Collaboration, Mentoring WORK EXPERIENCE

Sr. Associate II Sep 2019 - Present

Baxter Pharmaceuticals Ind Pvt Ltd

Responsible for leading microbiology operations, ensuring regulatory compliance and driving continuous improvement. Orchestrated daily activities and executed tasks, ensuring timely completion within stringent timelines. Designed and authored comprehensive microbiology protocols, including Method Validation, EMPQ, Hold Time, Shelf Life, and Disinfectant Protocol, accompanied by detailed experimental reports, ensuring scientific accuracy and reproducibility. Successfully navigated regulatory audits from USFDA, TGA, ANVISA, and MHRA, demonstrating unwavering compliance with global microbiological standards and GMP guidelines. Efficiently planned and allocated microbiological tests (Sterility, BET, Pre-Sterile, In-process, RM-PM Bioburden) to laboratory personnel, optimizing resource utilization and ensuring timely test completion. Analyzed and trended data related to isolates, bioburden, sterility, and BET utilizing SPC techniques (I-charts), environmental monitoring summaries (pie charts), and EMPQ (Pareto charts) to maintain manufacturing process control. Conducted spore bioburden assessments following excursions of terminally sterilized products, confirming Sterility Assurance Level (SAL) compliance and patient safety. Implemented and monitored Contamination Control Strategy (CCS) within the manufacturing facility, identifying areas for improvement and ensuring adherence to established protocols. Provided technical support and guidance to team members, fostering a collaborative environment and ensuring strict adherence to the Quality Management System (QMS).

Reviewed and approved critical microbiological documentation, including test reports, method validation reports, protocols, summaries, Electronic Lab Notebook data, and LIMS data, ensuring accuracy and compliance. EDUCATION

MSC Microbiology

MSC Microbiology, MJ college,Jalgaon

(2006)

Hobbies

Scientific Reading, Data Analysis, Process Improvement, Regulatory Research, Team Mentoring LANGUAGES

English, Marathi, Hindi

Oversaw environmental monitoring data, both routine and scheduled, identifying potential contamination risks and implementing corrective actions.

Functioned as Subject Matter Expert (SME) for the SKAN isolator system, actively participating in qualification and re- qualification efforts, guaranteeing system integrity and performance. Managed resource planning, optimizing the use of personnel, materials, and equipment, while implementing cost-effective approaches to laboratory operations.

Reviewed and approved essential quality documents, such as qualification and validation protocols, reports, and summaries, ensuring compliance with regulatory requirements.

Ensured the implementation and maintenance of current Good Manufacturing Practice (cGMP) standards and GLP principles through regular laboratory inspections and audits. Achievements:

Enhanced data analysis and trending practices utilizing statistical process control (SPC) techniques (I-charts), pie charts, and Pareto charts for microbiological data.

Streamlined laboratory operations by optimizing resource utilization and implementing cost-effective approaches. Instrumental in successful completion of regualtory audits (USFDA, TGA, ANVISA, MHRA). Sr. Microbiologist (Management Staff) Aug 2007 - Sep 2019 Sitec Labs Pvt Ltd

Responsible for sterility testing, microbial limit testing, and bacterial endotoxin testing for various materials and products. Conducted sterility testing on raw materials and finished products using both open and closed systems, catering to the US, EU, and China markets.

Performed Microbial Limit Tests (MLT) on finished products and raw materials, ensuring compliance with pharmacopeial standards.

Executed Bacterial Endotoxin Tests on finished products, sterile raw materials, Water for Injection, and Purified Water utilizing the Gel Clot method.

Undertook Microbial Kill Rate (MKD) studies for ophthalmic solutions, contributing to product development and quality control.

Achievements:

Delivered precise and compliant testing results, contributing to the market approval and distribution of pharmaceutical products in multiple international markets.

Maintained stringent quality control through accurate and reliable execution of a wide range of microbiological tests.

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