Executive Quality Control

Abbott; Solan; On-site; INR 300,000 - 420,000; Full time

Job summary

Abbott seeks a chemist for QC analysis of stability and finished products in the Hormone block. The role requires 2–4 years in chemical and instrumental analysis, with preference for an approved/licensed chemist.

You will ensure CAPA and GMP documentation and participate in regulatory audits such as MHRA and USFDA. Responsibilities include analysis of stability samples, instrument calibration, timely reporting, GLP/GMP compliance, and data entry in LIMS.

Qualifications

• B.Pharm / M.Sc with 2-4 years in Chemical & Instrumental analysis QC (Finished goods & stability).
• Licensed chemist preferred.
• Exposure to regulatory audits such as MHRA, USFDA, etc.
• Experience with CAPA and GMP documentation.

Responsibilities

• Analysis of Stability Samples/Finished Products as per STP/Specification in Quality Control of Hormone block.
• Calibration of routine instruments (Balance, pH meter, Conductivity meter).
• Timely analysis of stability samples and reporting of abnormalities.
• Stability sample charging, withdrawal, reconciliation and data entry in software such as LIMS.
• Implementation of GLP / GMP requirements and COBC alignment.
• Completion of assigned trainings of GLP/GMP on time.
• Reporting of stability/finished product samples and ensuring compliance with specifications.

Skills

CAPA

GMP Documentation

Regulatory Audits

Education

B.Pharm / M.Sc.

Tools

LIMS

Job description

Experience Required : B.Pharm / M. Sc. with 2-4 years of experience in Chemical & Instrumental analysis QC (Finished goods & stability). Approved chemist licensed candidate shall be preferred. Well versed with CAPA, GMP Documentation, should have exposure to regulatory audits such as MHRA, USFDA etc.

Followings will be the responsibilities of the position holder :

• Analysis of Stability Samples/ Finished Products as per respective STP/Specification in Quality Control of Hormone block.
• Calibration of routine usage instruments such as Balance, pH meter and Conductivity meter, as and when required.
• Timely analysis of stability samples and report if any abnormality observed.
• Timely Charging & withdrawal of samples from Stability Chambers & their documentation within the time frame.
• Sample reconciliation and destruction record of stability sample.
• Implementation of GLP / GMP requirements.
• Coordinating and aligning the practices and procedures in line with the COBC requirements
• Stability sample charging, Withdrawal, Reconciliation and data entry in software such as LIMS.
• Completion of assigned trainings of GLP/GMP on time
• Reporting of stability/Finished product sample as per report received from outside Laboratory and check the compliance against respective specifications.
• Evalutates the analysis results as per SOP and report to the supervisor for any abnormality.