Quality Engineer

We are seeking a detail-oriented Quality Engineer with experience in the pharmaceutical industry to support quality engineering activities across manufacturing and laboratory operations. The ideal candidate will have hands-on experience with deviations, CAPA, change control, validation, and GMP compliance.
Roles & Responsibilities :

• Support quality engineering activities for manufacturing and lab operations, including deviation investigations, CAPA, change control, and validation.
• Review batch records, SOPs, technical documents, and quality reports to ensure compliance with GMP, cGMP, and GLP standards.
• Assist in method development support, qualification activities, and validation documentation review for processes, equipment, and laboratory systems.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams to resolve quality issues and improve compliance.
• Participate in root cause investigations for deviations, out-of-trend results, and process issues.
• Support equipment qualification, calibration reviews, and maintenance documentation.
• Review and assess change control requests related to procedures, equipment, materials, and processes.
• Monitor quality metrics, trends, and recurring issues to drive continuous improvement.
• Assist in internal audits, compliance reviews, and inspection readiness.
• Maintain accurate and compliant quality documentation and records.

Education & Experience :

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related field.
• 4+ years of experience in Quality Engineering within the pharmaceutical or life sciences industry.
• Strong knowledge of GMP, cGMP, GLP, and regulatory compliance requirements.
• Experience with deviation management, CAPA, change control, and validation processes.
• Ability to review and interpret technical documents, SOPs, and batch records.
• Experience supporting FDA audits or regulatory inspections.
• Knowledge of risk management and quality systems.
• Familiarity with validation lifecycle (IQ, OQ, PQ).