Manager/Sr. Manager-Microbiology

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Stallion Laboratories Pvt Ltd

time outline icon Ahmedabad, Gujarat, India

Posted on 14-12-2023

523 Views

1 Vacancy

Description

Responsible for overall compliance of the Microbiology department.
Managing the Microbiology team to ensure work is carried out in compliance with the cGMP and USFDA norms.
Possesses strong elements / technical knowledge of microbiological aspects and experience in pharmaceutical industry includes analytical, method development/method validations, quality management system, set up of microbiology laboratory, equipment qualifications, strategic implementation, with hands on experience in various cGMP inspections.
Responsible for ensuring the scheduled microbiological testing of all kinds of water, finished products & environmental monitoring of controlled production areas.
Responsible for approval of analytical results like GPT, BET, MLT, Sterility testing and Antibiotic assay.
Preparation of Pure and productive laboratory culture inoculum for production plant.
Periodic Monitoring and troubleshooting of fermenter batches to maximize the productivity and minimize the contaminations.
Having expertise in QMS, Document control, Microbial Testing, validation, QMS, Environmental Monitoring, Sterility, BET, MLT,
Media fill, OOS, OOT, Deviation, CAPA, Risk Assessment, Investigation etc.
Responsible for review & update current versions of methods of analysis, SOPs & to prepare new methods, STPs and validation protocols.
Responsible for Preparation of change controls, Incidents, Deviations and CAPA forms along with Qualification Documents (DQ,
IQ, OQ & PQ) and periodic validation of instruments.
Responsible for review Log-books routinely & check for compliance as defined in SOPs for various activities.