Quality Engineer

We are seeking a detail-oriented Quality Engineer to support quality systems, regulatory compliance, and continuous improvement activities within a regulated pharmaceutical or life sciences environment. This role is well suited for recent graduates or early-career professionals interested in Quality Assurance (QA), compliance, validation, and quality systems
.

• Support the implementation, maintenance, and continuous improvement of Quality Management Systems (QMS).
• Assist in ensuring compliance with Good Manufacturing Practices (GMP) and applicable company quality standards.
• Support deviation reporting, investigation activities, root cause analysis, and appropriate documentation.
• Participate in CAPA (Corrective and Preventive Action) development, implementation, tracking, and effectiveness checks.
• Review batch manufacturing records, controlled documents, and other quality-related documentation for completeness and accuracy.
• Assist with preparation and coordination of internal, customer, and regulatory audits.
• Collaborate with Manufacturing, Quality Control (QC), Research & Development (R&D), and other cross-functional teams to resolve quality issues.
• Support process validation, equipment qualification, and related validation documentation activities.
• Maintain accurate and complete records in accordance with Good Documentation Practices (GDP) and applicable procedures.
• Track, compile, and analyze quality metrics, including deviations, CAPAs, complaints, and other quality indicators.
• Support change control activities and assess potential quality or compliance impacts as required.

• Basic understanding of Quality Management Systems (QMS) and pharmaceutical quality processes.
• Familiarity with regulatory requirements such as 21 CFR Part 11
  , GMP, and applicable quality standards is preferred.
• Basic knowledge of deviation management, CAPA, change control, and root cause analysis
  .
• Strong analytical, problem-solving, and attention-to-detail skills.
• Good written and verbal communication skills with the ability to work effectively with cross-functional teams.
• Proficiency in Microsoft Office
  , particularly Excel and Word.
• Ability to organize multiple tasks, maintain accurate documentation, and follow established procedures.