SENIOR OFFICER
JOHNSON AND JOHNSON
Total years of experience :14 years, 8 Months
PRESENT JOB RESPONSIBILITIES:
To support the setup of a new Microbiology Laboratory in Green field project.
Involved in ordering equipment, lab supplies, contacting various vendors and manufacturers, etc.
To support the development of LIMS and as member of the Project Execution Team for the Microbiology department.
Responsible for preparation of Protocols, SOP’s in coordination with cross functional team.
Responsible for execution of validation activities w.r.t microbiology equipment’s and instruments.
Responsible for Microbiology laboratory and Manufacturing area qualification.
Maintaining compliance with occupational safety and health, especially regarding hazardous materials and waste.
Effective handling of Non-Conformance, Laboratory investigations and CAPA through GEMS Track wise Software.
Ensures that CAPAs are appropriate for the elimination of quality issues.
Responsible to collaborate with manager to provide support in investigations/CAPA, troubleshooting, escalation and process quality issues.
Strong attention to detail and able to identify and act on situations which will require escalation.
Initiates, tracks, follows-up and assists in the timely closure of CAPAs and reviews all CAPA's to ensure documentation is complete before CAPA closure.
Strong analytical and Root Cause Analysis skills.
Sterility testing of in process samples and finished products using open and closed system.
Routine monitoring of Clean room and Controlled environments by microbiological techniques of settle plate method, surface contact method, volumetric air sampling and swab method.
Water sampling and microbiological analysis of water samples (Process water, Purified water and Water for injection).
Media preparation, Growth promotion test and media suitability tests.
Sub culturing, preservation, maintenance and purity check of reference cultures.
Isolation, Identification (Vitek 2 Compact-BioMerieux, BBL Crystal), preservation and maintenance of environmental isolates.
Involved in process simulation studies - Media Fill Trials (Sterile formulations).
Container Closure Integrity Testing - Microbiological method.
Sterility testing of in process samples and finished products using open and closed system.
Routine monitoring of Clean room and Controlled environments by microbiological techniques of settle plate method, surface contact method, volumetric air sampling and swab method.
Water sampling and microbiological analysis of water samples (Process water, Purified water and Water for injection).
Media preparation, Growth promotion test and media suitability tests.
Sub culturing, preservation, maintenance and purity check of reference cultures.
Isolation, Identification (Vitek 2 Compact-BioMerieux, BBL Crystal), preservation and maintenance of environmental isolates.
Involved in process simulation studies - Media Fill Trials (Sterile formulations).
Container Closure Integrity Testing - Microbiological method.
Sterility testing of in process samples and finished products using open and closed system.
Routine monitoring of Clean room and Controlled environments by microbiological techniques of settle plate method, surface contact method, volumetric air sampling and swab method.
Water sampling and microbiological analysis of water samples (Process water, Purified water and Water for injection).
Media preparation, Growth promotion test and media suitability tests.
Sub culturing, preservation, maintenance and purity check of reference cultures.
Isolation, Identification (Vitek 2 Compact-BioMerieux, BBL Crystal), preservation and maintenance of environmental isolates.
Involved in process simulation studies - Media Fill Trials (Sterile formulations).
Container Closure Integrity Testing - Microbiological method.
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