Junior Executive - Quality Control

Job Description:

Responsibilities

• Stability Sample Management
• Manage stability sample withdrawal, storage, and handling as per approved stability protocols and ICH Q1A(R2).
• Perform sampling of stability batches at defined time-points — initial, intermediate, accelerated, long-term, photo-stability, in-use, and stress studies.
• Ensure proper labelling, storage conditions, and segregation of stability samples in designated stability chambers.
• Stability Testing
• Conduct analysis of stability samples as per approved specifications and test procedures.
• Execute tests including Assay, Related Substances (HPLC), Dissolution profile, Content Uniformity, and physical parameters (description, hardness, friability, DT, water content) as applicable to stability study requirements.
• Ensure timely completion of stability testing and reporting as per stability protocol timelines.
• Document results in stability protocols, summary sheets, and reports.
• Chamber Monitoring & Trending
• Monitor and record stability chamber conditions (temperature, relative humidity) as per defined frequency.
• Maintain stability chambers — 25°C/60% RH, 30°C/65% RH, 40°C/75% RH.
• Respond to chamber excursions per SOP.
• Participate in trending and interpretation of stability data.
• Ensure timely review and notification for any trending abnormalities or failures.
• Analytical Instruments to be Handled
• Stability Chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH)
• HPLC, UV-Vis Spectrophotometer
• Dissolution Apparatus, Disintegration Tester
• Hardness & Friability Testers, KF auto-titrator
• pH meter, Analytical balances
• Documentation & Compliance
• Follow ALCOA+ principles for data integrity.
• Adhere to cGMP, GLP, ICH Q1A / Q1B / Q1E, and Schedule M norms.
• Maintain stability raw data, worksheets, and analytical records.
• Participate in internal audits, regulatory inspections, and CAPA closure.
• Ensure calibration and preventive maintenance of stability chambers and analytical instruments is up to date.

Qualification & Experience

• Qualification
• B.Sc / M.Sc / B.Pharm
• Experience
• 1 – 3 years (OSD experience preferred).