Executive & Senior Executive - Quality Control

Role Summary

The Executive / Senior Executive Quality Control ensures accurate testing of Raw Materials, InProcess, Finished Products, Stability samples, and Microbiological quality, supporting regulatory compliance and timely batch release.

Key Technical Responsibilities

• Perform RM, IP, FP, and Stability testing using validated methods.
• Operate analytical instruments: HPLC, GC, LCMS, UV, IR, Dissolution, Karl Fischer, Shimadzu systems.
• Conduct Wet Chemistry and assay/impurity profiling.
• Perform nasal spray product testing (droplet size, spray pattern, content uniformity).
• Ensure proper sample handling, storage, and disposal.

QC Micro-Specific Responsibilities

• Maintain and calibrate incubators, LAFs, autoclaves, colony counters.
• Prepare and qualify media, cultures, and reagents.
• Conduct EM trending, water bioburden, and microbial investigations.
• Support sterility assurance and contamination control programs.

Documentation & Compliance

• Record data in compliance with cGMP, GLP, ALCOA+ principles.
• Prepare COAs, raw data sheets, logbooks, and maintain audit-ready documentation.
• Handle OOS/OOT, deviations, and support investigations.
• Ensure adherence to SOPs, regulatory guidelines (USFDA, MHRA, WHO).

Executive vs Senior Executive Scope

TestingPerforms routine chemical & micro testsReviews, approves, and oversees testingInstrumentationOperates instrumentsTroubleshoots, calibrates, mentors teamDocumentationRecords and compiles dataReviews data, ensures complianceInvestigationsSupports OOS/OOTLeads investigations & CAPATeam ManagementIndividual contributorGuides analysts, coordinates workloadAuditsSupports audit readinessLeads audit responses & documentation

Qualifications

• B.Pharm / M.Pharm / M.Sc (Chemistry / Microbiology)

Experience

• Executive: 2-5 years in QC Chemical/Micro
• Senior Executive: 58 years with strong analytical & microbiology exposure

Skills

• Strong knowledge of analytical chemistry & microbiology
• Hands-on experience with HPLC/GC/LCMS and micro techniques
• Understanding of regulatory expectations
• Good communication, documentation, and troubleshooting skills