Microbiologist

Title – QE- Microbiologist/ Asst. Manager – Microbiologist

Responsibilities :

o Plan, coordinate, execute, and documents process validation and capability studies.

o Plan, coordinate, execute, and documents process and process improvement studies.

o Perform and document investigations, including root cause analysis for customer complaints, scrap, rejects, clean room monitoring, microbiological and sterilization issues etc.

o Support Operations & GQM strategic plans in leading or supporting projects.

o Plan, coordinate, and document quality plans.

o Plan, coordinate, and document work instructions and other quality documents.

o Plan, coordinate, test/inspection methods including the installation and purchase of equipments.

o Conduct training on defect awareness, hygiene and contamination control and good manufacturing practice including clean room practices.

o Coordination with various regulatory authorities including FDA, Haryana and CDSCO.

o Development, Maintenance and Analysis of Data in QM module of the plant.

o Control, Monitoring and Maintenance of Clean Room and other associated areas.

o Sterilization Validation and monitoring and Microbiological testing.

o Other responsibilities as brief by the Supervisor or corporate sterilization from time to time.

Physical Requirements:

o Prolonged periods of sitting.

o Ability to interface with a computer for long periods of time.

o Frequent movement over large manufacturing floor area.

o Constant utilization of speaking and listening skills, both person to person and telephonically.

o Frequent local travel requirements in and around Bawal.

Qualifications:

o Approved Microbiologist.

o Graduate\Post Graduate in Microbiology, Biotechnology or related study.

o Preferred experience of medical device/pharmaceutical industry/other related industry. Minimum 3 years experience desired.

o Prior training and experience to ISO 13485:2016, ISO 1900, US FDA CGMP and Lead Auditor preferred.

o Experience in working with multi national company preferred

o SAP and product sterilization experience desired.

o Most possess and be able to demonstrate strong analytical (troubleshooting) skills.

o Required computer skills: proficient working knowledge of Microsoft office products.

Same as External