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
- Valuable knowledge of Microbiology, skill to perform assigned task, communication in English
📌 Junior Team Member - Microbiology (India)
🏢 Nameless
📍 India
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