Quality Assurance Officer

Role Overview

We are seeking a dedicated Quality Assurance Officer to support the Marketing Authorisation Holder (MAH) in maintaining a robust Pharmaceutical Quality System (PQS), ensuring strict adherence to EU GMP and GDP regulations. This role involves quality assurance oversight for batch release, regulatory compliance, and collaboration with various external partners and internal departments to uphold high-quality pharmaceutical standards.

Key Responsibilities

• Maintain and update the Pharmaceutical Quality System in compliance with EU GMP and MAH mandates.
• Create, revise, and manage standard operating procedures (SOPs), quality policies, and controlled documentation.
• Conduct quality assurance reviews of batch records before market release, including monitoring and following up on deviations, out-of-specification or out-of-trend investigations, and other quality incidents affecting batch release.
• Manage change control processes, handle deviations, track CAPA activities, and verify their effectiveness.
• Coordinate and review Annual Product Quality Reviews and other periodic quality reporting.
• Oversee documentation linked to product distribution releases, customer complaints, product returns, recalls, and stability programs.
• Support qualification and ongoing monitoring of API manufacturers, contract manufacturing organizations, contract laboratories, distributors, and service providers.
• Participate in audit activities and ensure timely resolution of audit observations.
• Maintain and update quality agreements ensuring compliance and enforcement.
• Facilitate the exchange of quality data and documentation flow with external partners.
• Supervise storage and transportation conditions where applicable.
• Identify process improvement opportunities to strengthen quality procedures and documentation.
• Contribute to quality metrics generation and inputs for management review meetings.

Qualifications and Experience

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of five years’ experience in pharmaceutical quality assurance, including knowledge of GMP/GDP compliance and MAH operations.
• Familiarity with EU GMP guidelines (Part I and Annex 16) and GDP principles.
• Experience collaborating with contract manufacturing organizations or outsourced production is advantageous.
• Excellent documentation, communication, and organizational competencies.

Core Competencies

• Strong attention to detail with a quality-first mindset.
• Effective communication and teamwork skills.
• Ability to manage multiple priorities and meet deadlines.
• Analytical and problem-solving capabilities.
• Adaptable, proactive, and able to work efficiently in a small company setting.