QC Officer

We are seeking a detail-oriented and experienced Quality Control Officer to handle stability testing and documentation as per regulatory guidelines (ICH, WHO, USFDA, etc.). The role involves routine and accelerated stability studies, sample analysis, and maintaining GMP-compliant records.

Key Responsibilities:

• Conduct physical and chemical stability testing of drug products as per stability protocols.
• Prepare and review stability study protocols, reports, and data sheets.
• Perform routine and accelerated stability sample testing using analytical techniques (HPLC, UV, dissolution, etc.).
• Maintain stability chambers, monitor conditions, and ensure calibration and documentation.
• Follow ICH guidelines (Q1A-Q1F) and regulatory requirements for stability studies.
• Ensure timely sampling, analysis, and data entry in LIMS or related systems.
• Support investigations for OOS/OOT results and assist in CAPA implementation.
• Coordinate with QA, AR&D, and production teams for stability-related activities.
• Maintain all records and documentation as per cGMP and data integrity requirements.
• Support during regulatory audits and inspections.

Requirements:

• B.Sc. / M.Sc. in Chemistry, Pharmaceutical Sciences, or related field
• 1–2 years of experience in stability testing within a pharmaceutical QC lab
• Hands-on experience with instruments like HPLC, UV, dissolution apparatus, pH meter, etc.
• Knowledge of ICH stability guidelines and cGMP practices
• Familiarity with GLP documentation and audit readiness
• Good analytical, observation, and reporting skills

Job Types: Full-time, Permanent

Pay: Up to ₹25,000.00 per month

Benefits:

• Food provided
• Leave encashment
• Provident Fund

Work Location: In person