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BriefCase

Associate-microbiology Job in Stelis Biopharma

Associate-microbiology

Stelis Biopharma 4+ weeks ago
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Job Summary

Job Description:This position will form an integral part of quality department in achieving quality objectives by following current quality procedures and systems in line with regulatory and organization expectations. Need to work closely with team members and with other cross functional departments in a collaborative manner to achieve assigned deliverables. Primary Responsibilities: To be an integral part in achieving quality objectives by adhering to current quality procedures and systems in line with regulatory and organization expectations.To execute assigned responsibilities timely as per standard procedures to meet department deliverables.To maintain laboratory upkeep and to ensure continuous improvement and adherence to GLP and GDP.Responsible to coordinate and provide required support to cross functional departments in various activities like process validation, facility / equipment, cleaning validation etc.Responsible for preparation of URS, SOP, Protocol as required.Responsible for execution and support in installation and qualification of equipment / instrumentProcurement and inventory maintenance of consumables stock. Coordinating with vendors for supply and receipt of materials and accounting the bills for payment clearance. Responsible for receipt, storage and handling of media, accessories and samplesResponsible for operation, calibration and maintenance of laboratory instrument / equipmentResponsible for maintaining online Laboratory recordsResponsible for Review of analytical test report.Responsible to perform Microbiological assaysResponsible for performing microbiological analysis like sterility, BET, MLT, DET etc. Responsible for preparation and review of trend analysis of water system and environmental monitoring.Responsible for incubator temperature data acquisition and reviewResponsible for operation, calibration and maintenance of equipment / instruments (as applicableResponsible for reporting and handling of excursion / OOS results of environmental monitoring, water testing and other microbiological test results.Responsible for performing non-routine validation / study.Responsible for initiation of change control, deviation, CAPA, OOS and quality management system as requiredResponsible for inventory management of consumables stockResponsible for maintaining laboratory procedures in accordance with good laboratory practices standards.To participate in periodic review of quality system procedures at site i.e. belonging to cross functional department and suggest improvement as required.Any other responsibilities as assigned by department head designee
Additional Responsibilities: Responsible to impart training / conduct training and to ensure analysts are trained on procedures pertaining to their responsibilities. Responsible to work in co-ordination with team members and superior which will be integral part in team building to achieve departmental deliverablesResponsible to attend technical and procedural trainings to develop skill and competency.Responsible to c-ordinate with cross functional team in product / sample release.Responsible to utilize resources as per the FIFO and FEFO.Responsible for planning, procurement and utilize available resources without wastage and within the approved budget .
Educational qualifications preferredCategory: Master's DegreeField specialization: Microbiology, general
Experience Required :

2 to 5 Years

Vacancy :

1 Hire

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