Quality Engineer

Job Title:Quality Engineer

Type: Contract

Location: Remote

Experience:0-2 years

Job Summary:

We are looking for a detail-oriented Quality Engineer to support quality systems, compliance, and continuous improvement initiatives in a regulated pharmaceutical or life sciences environment. This role is ideal for recent graduates interested in Quality Assurance (QA), Compliance, and Validation.

Key Responsibilities:

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and company quality standards.
• Assist in deviation investigations, root cause analysis, and documentation of corrective actions.
• Participate in Corrective and Preventive Action (CAPA) activities and monitor implementation.
• Review batch manufacturing records and quality documentation for accuracy and compliance.
• Support internal, customer, and regulatory audits by preparing documentation and addressing audit findings.
• Collaborate with Production, Quality Control (QC), Validation, and R&D teams to maintain product quality and process compliance.
• Assist with process validation, equipment qualification, and related documentation.
• Maintain accurate and complete documentation in accordance with regulatory requirements and company procedures.
• Monitor, analyze, and report quality metrics, including deviations, complaints, and CAPA effectiveness.

Required Skills:

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Biomedical Engineering, or a related field.
• 0–2 years of experience (internships or academic projects are acceptable).
• Basic understanding of QMS, GMP, CAPA, deviation management, and change control.
• Knowledge of 21 CFR Part 11 and regulatory compliance is preferred.
• Strong analytical, problem-solving, documentation, and communication skills.
• Proficiency in Microsoft Excel, Word, and other MS Office applications.