Quality Control Executive - Reviewer

Sterling Healthcare; Pune District; On-site; INR 400,000 - 700,000; Full time

Job summary

Sterling Healthcare in Talegaon, Pune, is seeking a Quality Control Executive-Reviewer to lead stability studies, oversee sample handling, and ensure data integrity across raw materials and finished products. The role requires BSc/MSc in chemistry, strong GMP/GDP knowledge, and hands-on experience with HPLC, spectrophotometers, and instrument validation.

You will maintain SOPs, review analyses, and prepare certificates of analysis.

Qualifications

• Stability studies planning and monitoring.
• High emphasis on data integrity and accurate analytical reports.
• Review of analytical data and Annex-II documenting findings.
• Follow GMP and GLP in QC laboratory.
• Hands-on with HPLC and associated instruments.

Responsibilities

• Plan, execute and monitor stability samples analysis.
• Maintain stability study records and storage conditions.
• Ensure calibration/validation of stability chambers and equipment.
• Review analytical reports and prepare COAs for materials and finished products.
• Investigate OOS/OOT incidents and follow SOPs for stability analysis.
• Ensure data integrity and proper documentation in soft/hard copies.

Skills

Stability studies

Data integrity

Analytical review

SOP adherence

HPLC

Calibration

Instrument handling

GMP

QA documentation

Education

B.Sc. Chemistry

M.Sc. Chemistry

Tools

HPLC

UV

pH meter

Karl Fischer

Friabilator

Dissolution tester

IR spectrophotometer

Hardness tester

Balance

ERP

Job description

Job Title: Quality Control Executive- Reviewer

Department: Quality Control

Industry: Pharmaceutical (Sterling Healthcare)

Location: Talegaon, Pune

Education: B.sc Chem/ M.sc Chem

Experience: 49 years

Role & responsibilities

• Planning, execution and monitoring of stability samples analysis.
• To maintain stability study of finished products.
• Charging and withdrawal of stability samples as per the relevant stability protocol and SOP.
• To maintain the stability samples location chart and to ensure the samples are stored as per the location.
• Maintain the stability chamber equipment usage log and Reconciliation of stability samples.
• Daily monitoring and maintenance of temperature and relative humidity records of stability chambers. Daily printout of stability chambers.
• Maintenance of stability chambers.
• Operation and calibration / validation of stability chambers.
• Validation of alarm system and ensure the appropriate actions are taken. In case any excursion observed in any shift, the action shall be taken immediately
• To ensure all incoming samples are stored as per the defined storage condition and log is maintained. To store the under analysis samples of stability at storage conditions as per SOP.
• To do the planning for analysis of stability samples and ensure the analysis is completed within a time period.
• To review the analytical reports of stability samples
• To prepare the updated stability report of each storage condition.
• To ensure there is no data integrity in the documents of stability study.
• To ensure the soft copies of temperature and humidity records are available in software.
• To follow the incidence /OOS /OOT procedure in case of any incident happens during stability samples analysis. To investigate the incidences /OOS /OOT of stability analysis if any.
• Analysis and review of raw material, vendor samples, semi-finished, finished products, stability, method validation, process validation, hold time study and cleaning validation samples.
• To crosscheck and review the analytical data/report. To ensure the analysis data is correct and verify soft copy of the data with hard copy. After review the analytical data he is responsible to record the findings of analytical review in Annex-II of SOP of Good Laboratory Practice. (Checklist for review of analytical report).
• Preparation of certificate of analysis for Raw material and Finished product.
• Preparation and handling of placebo.
• Analysis of rinse and swab samples.
• Operation, cleaning and maintenance of analytical balance, pH meter, HPLC, UV, Karl Fischer, Potentiometer, IR Spectrophotometer, Friabilator, Hardness tester, Dissolution test apparatus and Disintegration test apparatus as per the relevant standard operating procedure .
• Qualification and Maintenance of working standard, reference standard and impurity standards for analysis of HPLC samples. Maintain the usage log book for consumption record of working standard , reference standard and impurity standards
• Issuance of HPLC column as per respective standard testing procedure for the use during routine analysis. Performance checks of new HPLC/GC column and ensures suitability of column for analysis of particular test. Maintain the usage logbook of HPLC/GC Columns.
• Receipt, issuance and usage of Reference standard/Impurity standard and working standards. Maintain the usage log book for consumption record of working standard, reference standard and impurity standards.
• Ensures the cleaning and sanitization of quality control laboratory.
• Disposition of analyzed samples after analysis.
• Handling of laboratory software with individual user login.
• Use of Refrigerator for storage of reference standard, working standard and impurity standards. Use of working standard cabinet for storage of working standard.
• Qualification of analytical instruments as per relevant standard testing procedure.
• Indent of chemicals, standards, columns and other laboratory needs through ERP.
• Maintenance of training records.
• Follow the good laboratory practices, good manufacturing and good chromatographic practices in the quality control laboratory.
• Follow the safety precautions during routine analysis.