Analyst
Julphar
Total years of experience :12 years, 11 Months
Formulation- cephalosporin oral solid dosage, dry
powder injection, liquid injections, lyophilized products, general oral solid dose, and
hormones soft gel manufacturer. \[Accredited with USFDA, EU-GMP, NDA, PICS, ISO
and COLUMBIA-GMP\].
(Formulation Dry powder cephalosporin). \[Accredited with
MHRA MCC, NDA, PICS, WHO, UKRAIN AND TFDA\].
Manufacturer of eye
drops, liquid injection, Disinfectant manufacturer and Public laboratory)
Handled and Technical Skill:
Microbiology:
o Planning, work allocation and provide periodic training to analyst.
o Controls and monitors OPEX/CAPEX budgets for Microbiology Laboratory
o Preparation and review of SOPs, GTPs, STPs, Specs and Validation protocol.
o Development of validation protocol for New water system.
o Under taking all aspects of microbiological testing like hold time study
samples, In process, Raw materials and Finished products.
o Reports review with traceability and release.
o Involve and perform, autoclave validation and water system validation.
o Under taking all aspects of microbiological testing like hold time study
samples, In process, Raw materials and Finished products.
o Analytical method validation - Sterility, BET and MLT.
o Involve Media fill validation, and water system validation.
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o Environmental Monitoring aseptic area - active, passive, surface monitoring
and personnel monitoring reports compilation and trend preparation.
o Investigation of quality notification such as OOS and OOT.
o Inventory and stocktaking, purchase order of laboratory.
o Updating and revision of Microbiology documentation, procedures,
work instructions and work sheets as per current USP and EP
o Planning and execution of disinfectant validation, media hold time study,
culture suspension hold time study, UV light efficacystudy, SterilizedGarment
hold time study, Compressed air and Nitrogen gas study.
o Ensure and compilation report for non-viable particle count.
o Assisting in auditing activities and take corrective action and preventive action
(CAPA) to ensure regulatory compliance.
o Responsible for following GDP, GMP, and GLP procedures.
o Risk assessment study for environmental monitoring and fix alert and action
limit.
o Performing LOPC test for particle size
o Involve HVAC area qualification activity.
* Purity check lyophilized culture revival and maintain.
* Gases (Compressed) sample Analysis.
* Performance verification of Biological Indictor Qualification.
* Execution of disinfectant validation, media hold time study, culture
suspension hold time study and UV light efficacy, Compressed air study.
* Performance requalification of autoclave and efficacy for Disinfectant
efficacy, UV light efficacy, media hold time study.
* Performing Growth promotion test and microbial limit testing of
pharmaceutical products.
* Responsible for receiving and maintenance of stock cultures of relevant USP
microorganisms.
* Receiving and performing growth promotion testing of incoming lots of
microbiological media.
* Identification of Microorganisms up to the species using BBL Crystal. and
BIOLOG
* Bio-burden of Primary Packing material & Water analysis by using membrane
filtration method.
* LIMS (Laboratory Information Management System), results trending and
reporting of micro results for raw materials, process, equipment, finished
product and environment.
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Grade : First Class Degree