Quality Assurance Specialist - Deviations

Role Overview

The Quality Assurance Specialist focusing on deviations plays a critical role in overseeing quality assurance processes involving deviations, investigations, CAPAs, and change control activities. This position involves collaboration with multiple departments such as Manufacturing, Engineering, Validation, Quality Control, and Supply Chain to ensure that investigations are appropriately managed in accordance with GMP standards, regulatory guidelines, and internal company policies.

Key Responsibilities

• Manage and oversee deviations, investigations, CAPAs, and change controls, ensuring compliance with timelines and regulations.
• Review and authorize quality documentation, ensuring thorough root cause analysis, risk assessment, and implementation of corrective actions.
• Act as a QA representative at Deviation Review Boards, Change Control Boards, and other interdisciplinary meetings.
• Provide expert guidance on complex investigations and assist with compliance and operational challenges.
• Track quality system trends and promote continuous quality improvements.
• Contribute to the preparation of Annual Product Reviews and reporting of quality metrics.
• Support internal quality audits, regulatory inspections, and readiness for inspections.
• Ensure all work is performed in line with company safety protocols and standard operating procedures.
• Adapt responsibilities to include additional tasks based on evolving business requirements.

Candidate Requirements

• Bachelor’s degree in Science, Engineering, Pharmacy, Biotechnology, or a closely related field.
• At least five years of professional experience within pharmaceutical or biotechnology sectors.
• Proven experience overseeing deviations, investigations, CAPAs, and change controls within GMP-regulated environments.
• Strong knowledge of GMP standards, quality management systems, and risk mitigation strategies.
• Excellent analytical thinking, problem-solving ability, and communication skills with experience in stakeholder engagement.
• Capability to work autonomously and effectively within cross-functional teams.
• Outstanding organizational abilities, communication proficiency, coordination, and meeting facilitation skills.
• Demonstrated history of driving continuous quality improvement initiatives in regulated contexts.