Senior Manager

Cadila Pharmaceuticals Limited

Dholka

On-site

INR 350,000 - 480,000

Full time

4 days ago

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Job summary

Cadila Pharmaceuticals Limited in Gujarat seeks a Quality Control Lab professional to uphold cGMP/GLP standards, monitor stability programs, review COAs, and maintain meticulous online documentation in the QC lab. You will coordinate sample analyses, keep instrument logs, participate in audits, and implement CAPA for OOS/OOT events, ensuring timely, accurate results and strict SOP adherence.

This role involves training analysts, collaborating with HOD, and ensuring safety and regulatory

Responsibilities

Follow cGMP and GLP practices in Quality Control Lab.
Monitor the stability program as per regulatory guideline and stability protocol.
Allocate the stability sample to analysis and destroy after completion of analysis.
Follow safety procedures in QC department.
Attend the training as per schedule.
Receive samples for analysis and make entry in Inward register.
Maintain the instruments log books related to sample analysis.
Review and approve the stability protocol and stability summary report.
Attend the regulatory / vendor audit and provide the compliance report.
Responsible for online documentation.
Review the incidence, OOS and OOT and take appropriate CAPA.
Review and approve the certificate of analysis of finished product and raw material.
Ensure current good laboratory compliance and SOPs are prepared/reviewed/implemented.
Follow safety procedures in QC department.
Manage accurate, reliable, efficient and timely review of finished products, in-process/validation, raw material, stability, GLP, Non-routine samples.
Ensure timely review of batch audit trail, system audit trail, message center.
Review Logbooks of instrument, equipment, columns, standards, impurities etc.
Review the COA of finished product in LIMS after analysis.
Ensure status label updated for instruments, equipment, glassware and workplace.
Conduct the training program to analysts as per the training calendar.
Provide training about changes in SOPs, if required.
Ensure the Sequence of HPLC/GC/IC are reviewed prior to start of sample set.
Ensure methods are prepared accordingly STP/SOP.
Ensure proper integration and reviewed prior to E-signature of data by reviewer
Do any other work assigned by HOD.

Job description

Job Description

Follow cGMP and GLP practices in Quality Control Lab.
To monitor the stability program as per regulatory guideline and stability protocol.
To allocate the stability sample to analysis and destroy after completion of analysis.
To follow safety procedure in QC department.
To attend the training as per schedule.
To receive the samples for analysis and making entry in Inward register.
To maintain the Instruments log books related to sample analysis.
To review and approve the stability protocol and stability summary report.
To attend the regulatory / vendor audit and provide the compliance report.
Responsible for online documentation.
To review the incidence, OOS and OOT and take appropriate CAPA.
To review and approve the certificate of analysis of finished product, raw material.
To ensure current good laboratory compliance and ensuring all SOPs related to Quality Control laboratory are prepared and reviewed / implemented properly.
To follow safety Procedure in QC department.
To manage an accurate, reliable, efficient and timely review of finished products, in process/ validation, raw material, stability, GLP, Non-routine samples.
To ensure timely review of batch audit trail, system audit trail, message center.
To ensure review of Logbooks of instrument, equipment’s, columns, standards, impurities etc.
To review the COA of finished product in LIMS after the completion of analysis.
To ensure the status label updated for the instruments, equipment, glassware and workplace.
To conduct the training program to analyst as per the training calendar.
To ensure the training about the changes in standard operating procedures (SOP), if required.
To ensure the Sequence of HPLC/GC/IC are reviewed prior to start of the sample set.
To ensure methods are prepared accordingly STP/SOP.
To ensure proper integration and reviewed prior to E- signature of data by reviewer
To do any other Work assign by HOD.