What are the responsibilities and job description for the Quality Engineer position at Katalyst CRO?
Summary
Summary :
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.
Responsibilities
Roles & Responsibilities :
Education & Experience :
Summary :
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.
Responsibilities
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).