Satbir Singh
@satbirsingh1
I am an experienced microbiology QC leader in pharmaceuticals.
IndiaWhat I'm looking for
I am an Assistant Manager in Quality Control (Microbiology) with 19 years' experience in pharmaceutical OSD manufacturing, currently leading the microbiology section at Torrent Pharmaceutical Ltd. since June 2013.
I specialize in microbial method validation, sterility testing, Bacterial Endotoxin Test (BET), microbial limit tests, water and area validation, and analytical method validation, and I draft SOPs, URS and qualification protocols (IQ/OQ/PQ).
I lead microbiology during regulatory audits (EU, Brazil/ANVISA, Russia, USFDA, TGA), manage OOS/OOT investigations, CAPA using Trackwise and Documentum workflows, and compile results through LIMS/SAP to ensure GMP/GLP/GDP compliance.
I provide team leadership and training, coordinate cross-functional validation and maintenance activities, and deliver troubleshooting and continuous improvement to maintain data integrity and audit readiness.
Experience
Work history, roles, and key accomplishments
TLAssistant Manager (Quality Control)
Torrent Pharmaceutical Ltd.
Jun 2013 - Present (12 years 2 months)
Head the Microbiology QC section, drafting SOPs and leading OOS/OOT investigations while ensuring compliance during regulatory audits (EU, Brazil, Russia) and CQA reviews.
QC Officer (Microbiology)
Ind Swift Ltd.
Jul 2008 - Jan 2013 (4 years 6 months)
Performed routine microbiological testing and environmental monitoring to support QC operations at an ISO/WHO-certified, USFDA/TGA-approved pharmaceutical facility.
QC Microbiologist
Mapex Remedies
Jul 2007 - Jul 2008 (1 year)
Conducted microbial testing and environmental monitoring for tablet manufacturing, supporting quality release and GMP compliance for finished products.
QC Microbiologist
Wings Pharmaceutical
Apr 2006 - Jul 2007 (1 year 3 months)
Executed routine microbiological analyses, area qualifications and equipment validations to maintain product and environmental quality in a WHO-certified manufacturing site.
Education
Degrees, certifications, and relevant coursework
BUBarkatullah University
Master of Science, Microbiology
Grade: First Division
Completed Master of Science in Microbiology from Barkatullah University, Bhopal in 2004 with First Division.
KUKurukshetra University
Postgraduate Diploma in Computer Application, Computer Application
Grade: Second Division
Completed Postgraduate Diploma in Computer Application from Kurukshetra University in 2002 with Second Division.
MRMaharshi Dayanand University, Rohtak
Bachelor of Science, Chemistry, Botany, Zoology
Grade: Second Division
Completed Bachelor of Science (Chemistry, Botany, Zoology) from Maharshi Dayanand University, Rohtak in 2000 with Second Division.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
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