Quality Assurance Specialist - Deviations

Role Summary

The Quality Assurance Specialist focusing on deviations offers expertise and supervision for handling deviations, investigations, Corrective and Preventive Actions (CAPAs), and change controls. Collaborating closely with departments such as Manufacturing, Engineering, Validation, Quality Control, and Supply Chain, this position ensures that quality investigations follow Good Manufacturing Practice (GMP) standards, regulatory directives, and organizational policies.

Key Duties

• Oversee the management and timely execution of deviations, investigations, CAPAs, and change controls with compliance adherence.
• Evaluate and sanction quality documentation, guaranteeing comprehensive scope, root cause identification, risk evaluation, and effective corrective measures.
• Act as the Quality Assurance representative in forums including Deviation Review Boards and Change Control Boards.
• Provide specialist support for complex investigations and advise on compliance and operational quality challenges.
• Track quality system performance metrics and assist with initiatives aimed at improving processes continuously.
• Participate in Annual Product Reviews and contribute to quality metric reporting as needed.
• Support internal quality audits, regulatory inspections, and maintain readiness for inspections.
• Execute all functions adhering strictly to safety protocols and Standard Operating Procedures (SOPs).
• Be prepared to broaden responsibilities in line with evolving business requirements.

Qualifications and Experience Required

• Bachelor's degree in Science, Engineering, Pharmacy, Biotechnology, or closely related fields.
• At least five years of relevant experience within pharmaceutical or biotechnology sectors.
• Proven expertise in providing QA oversight for deviations, investigations, CAPAs, and change controls under GMP conditions.
• Comprehensive knowledge of GMP regulations, quality management systems, and risk control methodologies.
• Strong analytical abilities paired with problem-solving skills, effective communication, and stakeholder engagement capabilities.
• Capability to work autonomously while collaborating efficiently across multifunctional teams.
• Excellent organizational, communication, meeting coordination, and facilitation skills.
• Evidence of contributing to ongoing improvements in regulated quality environments.