Senior Manager - Microbiology

Job Description:

Responsibilities

• Responsible for maintaining Microbiology laboratory in a State of All time Audit readiness.
• Responsible for Review of GLP documents like List of instruments, Calibration Schedule, AMC schedule, Trends, Annual summary but not limited to in both microbiology laboratories.
• Initiation & Investigation of Microbial Excursions, OOS, deviation, change control, Incident related to QC- Microbiology and cross functional Team.
• To ensure & testing, reporting & timely release of Microbiological samples like SFG, FG, Raw materials, In process, Intermediate, stability and packing materials, compressed air, swab samples of OSD facility, Inhaler & foam facility and Nasal facility.
• To ensure Periodic requalification of instrument/ equipment. Execution of Microbiological method validation verifications/ Miscellaneous studies.
• To ensure the working area / instruments cleanliness, and proper filing of documents and storage of the same at the respective place. Up keeping the all documents of with online entries. Maintain the ATR in Microbiology laboratory.
• Procurement, receipt, revival and maintenance of standard cultures. Identification and maintenance of isolated microbial cultures.
• Up keeping of all the documents with online entries. Review of all analytical and related documents like logbooks, TDS, protocol, report but not limited to.
• Review of all analytical and related documents like logbooks, TDS, protocol, report and SOPs but not limited to.
• Responsible to face internal and external inspection and provide compliance to audit observations.
• Act as an SME for Microbiology related events.
• Responsible to impart technical trainings to concerned staff related to Microbiology topics.

Qualification & Expeirence

• M. Sc.
• Years of experience: 15 to 20 Years