Our client is seeking a Quality Assurance Specialist who will be responsible for maintaining product quality and compliance by working closely with departments such as manufacturing, R&D, and regulatory affairs. This role involves reviewing documentation, leading audits, investigating deviations, overseeing project initiatives, managing document workflows, and offering back-up support for quality control functions.

Qualifications:

• Bachelor's in life sciences preferred
• 7+ years of quality assurance experience
• Expertise in conducting audits, inspections, and assessments
• Proficient in quality tools (e.g., Document Control, CAPA, Deviations, Audit, SPC)
• Strong understanding of GMP/ISO regulations and quality management systems
• Experience in the life sciences, pharmaceuticals
• Familiarity with eQMS, ERP systems, and other information systems

Key Responsibilities:

• Oversee CAPAs and document control
• Conduct internal audits and support external audits
• Review and approve quality documentation (e.g., SOPs, specifications)
• Ensure compliance with regulatory standards
• Investigate deviations and implement corrective actions
• Support the development and maintenance of quality systems
• Provide training on quality procedures and best practices
• Participate in risk assessments and quality improvement initiatives
• Track corrective and preventive actions to ensure timely resolution
• Support data analysis, reporting, and vendor audits
• Maintain accurate quality documentation and ensure compliance