Senior Quality Assurance Officer

Role Overview

We are seeking a Senior Quality Assurance Officer to support and maintain the Quality Management System (QMS) within a pharmaceutical third-party logistics (3PL) environment. The role is responsible for ensuring compliance with Good Distribution Practice (GDP), applicable regulatory requirements, and ISO management systems across warehousing, distribution, and outsourced activities. The successful candidate will play a key role in audit readiness, quality oversight, and continuous improvement initiatives.

Key Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in line with GDP and regulatory requirements.
• Review, update, and approve quality procedures, SOPs, and controlled documentation relevant to pharmaceutical warehousing and distribution activities.
• Support the training and competency of personnel in GDP, quality procedures, and company processes.
• Manage and monitor quality events including deviations, non-conformances, complaints, change controls, and Corrective and Preventive Actions (CAPA).
• Perform quality oversight of subcontracted and outsourced activities (e.g. transport providers, service contractors) to ensure GDP compliance.
• Support adherence to equipment, facility, and warehouse maintenance and calibration schedules in line with GDP expectations.
• Plan, conduct, and report internal audits; track and verify the effective implementation and closure of corrective actions.
• Support preparation for and participation in external audits and inspections by clients, Certification Bodies, and Regulatory Authorities.
• Ensure alignment of ISO Management Systems (ISO 9001, ISO 13485 where applicable, ISO 14001, ISO 45001) with GDP and pharmaceutical regulatory requirements.
• Identify gaps in QMS documentation and support the implementation of new or revised quality systems and processes.
• Review interdepartmental, transport, and warehouse documentation to ensure procedural compliance and data integrity.
• Monitor and maintain quality records related to pharmaceutical storage, handling, and distribution in accordance with GDP requirements.
• Oversee pest control and disinfestation programs, including contractor management and monthly applications.
• Provide quality performance updates, metrics, and reports to the Quality Assurance Manager.

Key Requirements

• Degree or diploma in Life Sciences, Pharmacy, Quality Management, or a related discipline.
• Proven experience in a Quality Assurance role within a pharmaceutical, biotech, or pharmaceutical logistics (3PL) environment.
• Strong working knowledge of Good Distribution Practice (GDP) and pharmaceutical quality systems.
• Experience supporting regulatory and client audits within a GDP-regulated warehouse or distribution setting.
• Hands-on experience with CAPA, deviations, change control, and QMS documentation.
• Strong attention to detail with excellent documentation and organizational skills.
• Effective communicator, able to work cross-functionally with warehouse operations, transport providers, and external auditors.
• Ability to work independently while escalating quality issues appropriately to the Quality Assurance Manager.

Desirable

• GDP training certification.
• Internal or Lead Auditor qualification.
• Experience working with cold chain and temperature-controlled distribution.
• Familiarity with regulatory authority inspections (e.g. HPRA, EMA or equivalent).