Quality Assurance / Quality Control Officer

We are seeking a Quality Assurance / Quality Control Officer to support and maintain the Quality Management System (QMS) within a pharmaceutical warehousing and distribution (3PL) environment. The successful candidate will ensure compliance with Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), applicable regulatory requirements, and ISO standards, while actively contributing to inspection readiness and the continuous improvement of quality processes.

Key Responsibilities

• Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in accordance with GDP/GMP requirements and pharmaceutical legislation.
• Review, update, and approve procedures, SOPs, and controlled documentation relating to pharmaceutical warehousing and distribution.
• Support the training and competency assessment of personnel on GDP/GMP requirements and quality procedures.
• Manage and monitor quality-related issues, including deviations, non-conformities, complaints, change controls, and Corrective and Preventive Actions (CAPAs).
• Provide quality oversight of subcontractors and external partners (e.g., transport companies and service providers) to ensure compliance with GDP requirements.
• Support compliance with maintenance, calibration, and inspection programs for equipment and facilities.
• Plan, conduct, and document internal audits, as well as monitor and verify the completion of corrective actions.
• Support the preparation for and participate in external inspections and audits conducted by customers, Certification Bodies, and Regulatory Authorities.
• Ensure the alignment of ISO Management Systems (ISO 9001, ISO 13485 where applicable, ISO 14001, and ISO 45001) with GDP/GMP requirements and pharmaceutical legislation.
• Identify gaps in QMS documentation and support the implementation of new or improved quality systems.
• Review cross-functional, warehousing, and transportation documentation to ensure compliance with approved procedures and Data Integrity principles.
• Monitor and maintain records related to the storage, handling, and distribution of pharmaceutical products in accordance with GDP requirements.
• Oversee pest control and rodent control programs, including the management of external service providers and monthly applications.
• Provide quality reports, key performance indicators, and updates to the Quality Assurance Manager/Director.

Required Qualifications

• Bachelor’s degree or diploma in Health Sciences, Pharmacy, Quality Management, or a related field.
• At least two (2) years of proven experience in a Quality Assurance/Quality Control role within a pharmaceutical, biotechnology, or pharmaceutical 3PL environment.
• Excellent knowledge of the principles and requirements of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and pharmaceutical quality systems.
• Experience supporting inspections and audits in pharmaceutical warehousing or distribution centers.
• Experience in managing CAPAs, deviations, change controls, and QMS documentation.
• Strong attention to detail, with excellent organizational and written communication skills.
• Ability to work effectively with warehouse, transportation, and external audit teams.
• Ability to work independently while appropriately escalating issues to the Quality Assurance Manager/Director.

Desirable Qualifications

• GDP training certification.
• Internal Auditor and/or Lead Auditor certification.
• Experience with cold-chain management and controlled-temperature conditions.
• Familiarity with inspections conducted by Regulatory Authorities (e.g., EOF, EMA, or equivalent authorities).