Quality Control Analyst

The QC Analyst

responsible for performing chemical, physical, and instrumental analysis of raw materials, packaging materials, finished products, stability, water, and other QC samples in compliance with approved methods, GMP/GLP, GDP, and data integrity requirements.

Responsibilities

• Perform routine and non-routine QC testing according to SOPs and pharmacopoeial methods.
• Analyze raw materials, packaging materials, finished products, stability, and water samples.
• Operate and maintain QC laboratory instruments (HPLC, UV, FTIR, dissolution, KF, etc.)
• Prepare reagents, standards, mobile phases, and sample solutions.
• Record and review analytical data, calculations, and test results accurately.
• Report OOS/OOT results, deviations, and instrument issues to supervision.
• Support validation, method transfer, stability, and investigation activities.
• Ensure proper handling of standards, reagents, and laboratory consumables.
• Maintain laboratory cleanliness, safety, and audit readiness.
• Comply with GMP, GLP, GDP, EHS, and data integrity requirements.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Science, or related field.
• 1-3 years of pharmaceutical QC laboratory experience preferred.
• Knowledge of GMP, GLP, GDP, data integrity, and pharmacopoeial requirements.
• Experience with HPLC, UV, FTIR, dissolution, KF, pH meter, and other QC instruments.
• Ability to follow analytical methods, perform calculations, and evaluate results accurately.
• Good documentation, communication, problem-solving, and teamwork skills.
• Familiarity with Empower, SAP, LIMS, or QMS is an advantage.