Rangpo Team Member Microbiology Sikk

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