Quality Assurance Specialist

Role Overview

This position ensures the affiliate’s quality management system remains robust and compliant with pharmaceutical regulations and internal standards, directly safeguarding patient access to reliably safe products. Day to day, you will monitor system performance, lead investigations, and coordinate process changes while interacting with warehouse, supply chain, and external partners to maintain quality across the product lifecycle. Your work supports uninterrupted supply and regulatory adherence, making you a critical link between quality assurance and operational delivery.

Key Responsibilities

• Conduct periodic management reviews of the quality system by tracking performance indicators against relevant benchmarks and presenting findings for continuous improvement.
• Implement and adapt divisional standard operating procedures (SOPs) to the local environment, ensuring alignment with ISO standards and regulatory expectations.
• Identify and manage non-conformities by investigating deviations through established quality systems, determining root causes, and executing timely corrective and preventive actions (CAPA).
• Lead change control processes: assess impact on processes, personnel, or systems, coordinate planned actions, and communicate changes to affected stakeholders.
• Perform quality risk assessments using appropriate tools, identify areas of risk, implement mitigation measures, and monitor effectiveness.
• Release commercial batches and investigational medicinal products to the local market in compliance with marketing authorizations, clinical trial authorizations, and local regulations; ensure key release metrics are met.
• Oversee product complaints by managing the dedicated mailbox, processing each case per SOP, and supporting complaint trending and reporting.
• Coordinate with supply chain to manage cold chain controls, support batch traceability for all received and distributed stock, and assist in annual mock recalls or actual recalls when required.

Requirements & Qualifications

• University degree in pharmacy, medicine, pharmaceutical chemistry and technology, or biology (or a related scientific discipline).
• Three to five years of experience in a pharmaceutical or medical device environment, specifically within regulatory and quality assurance management.
• Demonstrated ability to uphold rules and SOPs consistently, with a strong attention to compliance.
• Thorough knowledge of the current regulatory framework and quality assurance principles in the pharmaceutical sector.
• Familiarity with ISO standards relevant to quality management systems (e.g., ISO 9001, ISO 13485) and good manufacturing/distribution practices (GxP).
• Experience conducting internal audits, self-inspections, and external audits; ability to draft audit reports and follow up on corrective actions.
• Proficiency in managing quality agreements with GxP suppliers and overseeing warehouse/distribution partners for compliance with quality standards.
• Competence in training personnel involved in GxP activities and maintaining up-to-date knowledge through physical or virtual learning platforms.