Junior Team Member - Microbiology

Cipla; South Goa District; On-site; INR 360,000 - 720,000; Full time

Job summary

Cipla is seeking a microbiology QA/analytical professional in Goa to execute analysis of allocated samples, ensuring reliable results that meet predefined microbiological standards. The role involves data review, report preparation, and timely submissions to support release within SLA.

Responsibilities include investigations into deviations, CAPA actions, and meticulous documentation to comply with cGMP/GDP and GLP standards, with a focus on preventing non-compliances and maintaining instrument

Responsibilities

• Execute analysis of allocated samples and produce reliable and reproducible results to ensure compliance with microbiological quality parameters and predefined specifications and standards.
• Analyse samples as per priority and work allocation
• Review data as per respective specification, microbiological methods and results obtained
• Prepare, review and submit reports to Team Leader within stipulated timelines to support sample release within SLA.
• Initiate investigations and take necessary corrective and preventive actions for errors, abnormal observations and non-compliances related to procedures, equipment and instruments, delivering results promptly to facilitate timely action and avoid delays in releases.
• Investigate incidences and lab errors on priority basis so that batch release is timely and issues are not recurring.
• Document entries, raw data and findings concomitantly in relevant test data sheets to facilitate lab QA review and avoid missed entries.
• Review reports as per cGMP & GDP for compliance to GLP; ensure no GMP/regulatory concerns are raised by adhering to SOPs and procedures.
• Evaluate and document instrument/equipment breakdowns and suggest mechanisms to avoid recurrence; maintain equipment/instruments to prevent malfunctions.

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.

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

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

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

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