Junior Team Member - Microbiology

Cipla; Rangpo; On-site; INR 420,000 - 620,000; Full time

Job summary

Cipla is seeking a Microbiology Analyst to execute analysis of allocated samples and ensure reliable results in line with predefined specifications and quality standards.

The role involves prioritizing work, reviewing data, generating reports for Team Leader, and initiating corrective actions to support timely batch release while maintaining compliance with cGMP, GDP, and SOPs. Experience in English communication and 1–5 years in microbiology preferred.

Qualifications

• Must have MSc in Microbiology.
• 1–5 years experience for analyst, 3–7 years for reviewer in Microbiology.
• Good knowledge of Microbiology and English communication.
• Ability to review and release reports to meet SLA and ensure compliance.

Responsibilities

• Analyse samples as per priority and allocate work.
• Review data per specifications, microbiological methods and results.
• Prepare, review and submit reports to Team Leader within timelines.
• Initiate investigations and implement corrective actions.
• Ensure GMP/GDP compliance and adherence to SOPs.
• Maintain equipment and instruments to avoid non-compliance.

Skills

Microbiology knowledge

English communication

Education

M. Sc (Microbiology)

Job description

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 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)

• 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)

• 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)

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)

• 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.

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

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