Quality Engineer Pharmaceutical Manufacturing

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We are seeking an experienced Quality Engineer to lead quality assurance programs, regulatory compliance, and continuous improvement initiatives within a regulated manufacturing environment.

Key Responsibilities

• Develop and implement quality programs aligned with cGMP, ICH Q7, IPEC, ISO, and FDA requirements.
• Support and manage CAPA, complaint investigations, validation, stability, SPC, and quality systems.
• Lead root cause analysis, corrective actions, defect prevention, and process improvement initiatives.
• Manage supplier, customer, internal, and regulatory audits.
• Partner with customers to investigate and resolve quality complaints and inquiries.
• Develop and improve testing, inspection, validation, and quality control processes.
• Analyze quality data and implement solutions to improve product quality and compliance.
• Collaborate cross-functionally to maintain and continuously improve quality systems.

Must-Have Qualifications

• 5+ years of experience in Quality Engineering or a related role.
• Experience in pharmaceutical, biotechnology, chemical, or similarly regulated environments.
• Hands-on experience in cGMP and ISO 9000 regulated environments.
• Strong knowledge of quality systems, CAPA, investigations, validation, and audit processes.
• Strong analytical, problem-solving, and communication skills.
• Experience working with customers, suppliers, and regulatory stakeholders.

Education

• Bachelor s degree in Chemistry or a related field required.