Stallion Laboratories Hiring For Microbiology
Department
We at Stallion Laboratories Pvt. Ltd. are having some
exciting news to share with our Pharma colleagues.
We are having following opportunities for our Unit-2
(US-FDA approved) for very passionate,
dynamic and strong senior role in Microbiology Dept
Markets: US-FDA, MHRA, UK, TGA, Health Canada.
Salary is no bar for potential leaders.
Please send your cv on hrm@stallionlabs.com and do
specify subject line with Dept, name.
Department: Microbiology Dept
Position: Manager / Sr. Manager
Experience: Minimum 5 US-FDA audit faced
Job 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 inclu
analytical, method development/ method 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 monito 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.
