Open To Work
Harshwardhan Chinchkar
Pune
Summary
Detail-oriented Quality Control Officer with expertise in environmental monitoring, bacterial endotoxin testing, and microbial limit testing. Demonstrated compliance with ISO standards and effective documentation in high-stakes audit environments.
Overview
3
3
years of professional experience
2
2
Certifications
Work History
Quality Control Officer
Serum institute of India
Pune
10.2022 - Current
- Environmental Monitoring: Conducted viable and non-viable monitoring in Grade A to D cleanrooms, ensuring 100% compliance with ISO 14644 standards.
- Bacterial Endotoxin Testing (BET): Validated and executed LAL tests for raw materials, in-process samples, and finished products.
- Microbial Limit Test (MLT)/Bioburden: Validated and executed MLT for WFI points, and Bioburden tests for in-process samples and finished products.
- Audit Participation: Actively contributed to the successful completion of WHO, USFDA, MHRA, and CDSCO audits by maintaining meticulous documentation and face-to-face query resolution.
- Media Preparation: Managed growth promotion testing (GPT) for various media lots to ensure consistency in microbial recovery.
- Documentation: Authored and reviewed SOPs, Change Controls, OOS Investigations, performance qualifications of clean rooms, and deviation reports in compliance with ALCOA+ principles.
Education
Master of Science - Microbiology
P.E.S Modern College of Science
Pune07-2022
Bachelor of Science - Industrial Microbiology
M.E.S Abasaheb Garware College
Pune04-2020
Skills
- Environmental monitoring of clean rooms
- Bacterial endotoxin testing (kinetic turbidimetric assay)
- Microbial limit testing
- Biological indicator testing of strips, metal coins, and discs
- Closure container integrity test of media fill vials
- Culture management
- Media preparation and testing (GPT, GIT, and sterility
- LIMS, SAP, eLOG, eLMS, Valgenesis, and Caliber DMS operation
- Equipment qualification (IQ, OQ, PQ)
Languages
English
Upper Intermediate (B2)
B2
Hindi
Proficient (C2)
C2
Marathi
Native
Native
Certification
Pharmaceutical course (2022)
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Work Preference
Work Type
Full TimeLocation Preference
On-SiteHybridTimeline
Quality Control Officer
Serum institute of India
10.2022 - Current
Master of Science - Microbiology
P.E.S Modern College of Science
Bachelor of Science - Industrial Microbiology
M.E.S Abasaheb Garware College