Jr Executive - QC

Key Responsibilities

Stability Studies:

Perform stability testing of drug products as per ICH guidelines (ICH Q1A, Q1B, etc.).Execute physical, chemical, and instrumental testing (e.g., HPLC, GC, UV, IR) on stability samples.Maintain and monitor stability chambers (25°C/60% RH, 30°C/65% RH, 40°C/75% RH, etc.).Review and compile stability data and trend reports.Ensure timely sampling, testing, and documentation for ongoing and new stability studies.Assist in the investigation of OOS/OOT results in stability testing.

Raw Material (RM) Testing:

Conduct sampling and testing of raw materials (API, excipients) as per pharmacopoeial standards (USP, EP, IP, BP).Perform identification, assay, and impurity profiling using analytical techniques.Review raw material COAs and ensure vendor qualification data is compliant.Maintain RM specifications and update as per regulatory or pharmacopoeial changes.

General QC Responsibilities:

Operate and calibrate instruments like HPLC, GC, UV-Vis, FTIR, pH meter, balance, etc.Ensure all analytical work complies with cGMP, GLP, and company SOPs.Prepare and review analytical documentation (test reports, worksheets, protocols).Participate in internal and external audits (regulatory, client, etc.).Maintain laboratory records, logbooks, and instrument usage logs accurately.

Qualifications

:

Education

: B.Pharm / M.Pharm / B.Sc / M.Sc in Chemistry, Pharmaceutical Sciences, or related field.

Experience

: 2–5 years in a QC laboratory in the pharmaceutical industry, with specific experience in stability and raw material testing.

Knowledge

:Strong understanding of cGMP, ICH guidelines, and pharmacopoeial methods.Proficient in HPLC, GC, and wet chemistry techniques.Exposure to LIMS/ERP systems (optional but preferred).

Skills

:Attention to detail and strong documentation skills.Good understanding of analytical chemistry principles.Time management and ability to handle multiple priorities.Effective communication and teamwork skills.Ability to work independently under minimal supervision.