Team Member - Microbiology

InvaGen Pharmaceuticals Inc; Rangpo; On-site; INR 600,000 - 900,000; Full time

Job summary

InvaGen Pharmaceuticals Inc. is seeking a Microbiology Analyst/Reviewer to execute sample analysis and ensure results meet predefined microbiological quality parameters and standards.

The role requires M. Sc in Microbiology with 1–5 years for analyst and 3–7 years for reviewer, strong English communication, and adherence to cGMP/GDP. Responsibilities include data review, report submission, and initiating CAPAs to support timely releases.

Qualifications

• Bachelor/B.Sc. equivalent not stated; Master of Science in Microbiology is required.
• Good knowledge of Microbiology and ability to perform assigned tasks.
• English communication skills mandatory for team interaction and reporting.

Responsibilities

• Analyse and review samples based on priority and work allocation to meet SLA.
• Review data per specifications, microbiological methods and results.
• Prepare, review and submit reports to Team Leader within timelines to support sample release.
• Report errors, abnormal observations, non-compliances and deliver results promptly to avoid delays.
• Initiate investigations and take corrective and preventive actions as needed.
• Investigate incidents to ensure timely batch release and prevent recurrence.
• Document entries and raw data in test data sheets to aid QA review.
• Review reports per cGMP & GDP for compliance to GLP.
• Ensure no GMP/regulatory concerns by adhering to SOPs.
• Evaluate and document instrument/equipment breakdown and suggest mitigations; maintain equipment.
• Review environmental monitoring data and lab operations to ensure compliance.

Skills

English communication

Microbiology knowledge

Education

M. Sc (Microbiology)

Job description

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

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

Key Decisions (1/2)

Recommendations

Daily Media and Plates requirement (to Team Leader Microbiology)

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

Requirements: