Job Description

Department Details
Role Summary
The Role summary includes the following mentioned activities tentatively.
1. CCFs, Deviations, Incidents, Calibrations and Validations related to microbiology.
2. Preparation and review of EOP's, SOP's, GAM's product specifications and analytical
reports.
3. Review of process validation / cleaning validation protocols in co-ordination with Q.A.
4. Handling of incidents related to microbiology lab.
5. Responsible investigation of OOS results.
6. Performing the work assigned by the Incharge / Superior.
7. Planning of work in the absence of Incharge / Section head / Department head
Key Responsibilities
The Key Responsibilities includes the following

• Follow good documentation practices.
• Handling of change controls in Microbiology laboratory.
• Review of equipment and instruments usage logbooks.
• Preparation and review of Evaluation and establishment of microbiological specifications

reports.

• Review of media, growth promotion test records.
• Review of culture documents.
• Review of environmental monitoring data report, trends.
• Review of water sampling and testing report, trends.
• Review of Microbial Limit Test reports.
• Review of Bacterial Endotoxin Testing reports.
• Preparation and review of standard operation procedure.
• Review of disinfectant preparation and cleaning records.
• Review of daily monitoring records.
• Preparation and Review of calibration, PM schedules
• Review of samples in LIMS.
• Perform and review of data backups.
• Preparation and Review of reports for Evaluation and establishment of microbiological

specifications for active pharmaceutical ingredients.

• Preparation of product specifications and STP's.
• Review of training records.
• Preparation and review of method transfer protocols, reports.
• Preparation and review of schedules, sampling schemes planner.
• Preparation and review of isolate trends.
• Preparation and review method validation assessment.
• Preparation and review of method validation documents.
• Preparation and review of instrument, equipment qualification records.
• Review of calibration records manual and LIMS.
• Preparation and review of investigation reports, such as incidents, OOT, OOS, Deviations

and any nonconformance.

• Preparation and review of CAPA reports.
• Preparation and review of standard operating procedures, Equipment operating

procedures.

• Preparation and review of specification and standard testing procedures.
• Preparation and review of other QMS documents.
• Operation of file net and any other documentation systems.
• Follow laboratory safety practices.

Spread awareness amongst the people on the Biocon Ethical Practices & Integrity Policy,
Whistler Blower Policy and Zero Tolerance Policy.
Educational Qualifications
Required Education Qualification: M.Sc
Required Experience: 8 - 10 years

Skills Required