Team Member - Microbiology

Job description

**Division** **Department** **Sub Department 1** **Job Purpose** Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. **Key Accountabilities (1/6)** **Analyse and review samples based on work allocation to meet the service level agreement** - Analyse samples as per priority and work allocation - Review the data as per respective specification, Microbiological Methods and results obtained - Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA **Key Accountabilities (2/6)** **Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases** - Initiate investigations and take necessary corrective and preventive actions - Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring **Key Accountabilities (3/6)** **Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries** - Review reports as per cGMP & GDP for compliance to GLP - Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures **Key Accountabilities (4/6)** **Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same** Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments **Key Accountabilities (5/6)** **Key Accountabilities (6/6)** **Major Challenges** - Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites. - Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA **Key Interactions (1/2)** **Internal** - Units for receiving specification, documents, protocols, area availability etc. (daily) - QA/QC for product sample release (daily) - Stores for procuring materials(need basis) - Communicate if any observation find on the specification **Key Interactions (2/2)** **External** **CQA** for procuring pharmacopial guidelines (need basis) **Dimensions (1/2)** - Review and release approximate 15 MLT reports on daily basis to achieve the SLA. - Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples. - 50 Water Samples analysis and release - 10 Technical Information Sheets for swap analysis - 6 Autoclave & DHS Operation - 200 locations released on daily basis for Environmental monitoring **Dimensions (2/2)** **Key Decisions (1/2)** **Recommendations** Daily Media and Plates requirement (to Team Leader Microbiology) **Key Decisions (2/2)** **Education Qualification** M. Sc (Microbiology) **Relevant Work Experience** - 1-5 years’ experience for analyst and 3-7 years for reviewer in Microbiology - Good knowledge of Microbiology, skill to perform assigned task, communication in English