Quality Assurance Specialist - KSA & NDM (External)

The QA Specialist role is based in Jeddah, Saudi Arabia and will report directly to the QA / QP Manager. The role will be responsible for managing product quality release activities, supporting QA manager in executing all assigned Quality‑related activities within KSA / NDM, as well supporting META QA team as needed.

Key Responsibilities

Support QA / QP manager with all Quality‑related activities in KSA & NDM markets.

Perform product batch release activities according to internal procedures (SAP system) and local regulations.

Support QA / QP manager in accordance with local regulations and Acino standards for the manufacture and testing of externally manufactured medicinal products.

Support the maintenance and improvement of external supplier quality oversight including supplier qualification, supplier risk management and follow‑up on GDP audits.

Implement and monitor the Quality Management System (QMS), Technical Quality Agreements (TQAs) and all other Quality related documents i.e. Master documents, SOPs etc.

Handle deviation, CAPA, change control, complaint reports or other quality relevant documents.

Perform GDP compliance check for products where Acino local Office acts as local responsible party for GDP.

Participate in internal and external audits and inspections of suppliers, contract manufacturers, laboratories, packagers, distributors, logistic service providers as per plan, write audit report and follow‑up on CAPAs.

Keep up to date with the relevant regulations and guidelines.

Ensure compliance with the Saudi FDA & EU guidelines for GMP, GDP and local requirements.

Manage change control of all quality changes from 3rd parties in the respective system (e.g., Track wise).

Adhere to ACINO internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.

Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance / Pharmacovigilance / Medical Affairs.

Support training activities in the Saudi on the annual training plan and roll‑out trainings from the system according to training matrix and ensure quality awareness training for KSA / NDM cluster employee.

Support META QA team as needed in quality activities i.e. GDP audit, QMS system, TQA updates …etc

Qualifications & Experience

University degree in Pharmacy, Sciences i.e. Biomedical, Biochemistry, Chemistry, Laboratory, Microbiology, or relevant.

Language : Arabic (native) and English proficient is a must.

Saudi Nationals Only

Experience & Competencies

5 years professional experience in pharmaceutical industry & QA.

Practical experience in GMP / GDP within pharmaceutical industry i.e. in Production, Quality Control and / or Quality Assurance in Saudi Arabia.

Good understanding and knowledge of GxP regulations (EU, FDA, WHO etc).

Experience in using QMS systems such as Track wise or other QMS systems.

Experience with electronic systems i.e. (SAP).

Experience of working in a cross‑functional environment.

Able to work in an international and interdisciplinary environment.

Strong communication and influencing skills to be able to communicate (verbal and written) technical and non‑technical information clearly to business function.

High analytical and process‑oriented mindset combined with the capability of understanding complex situations and processes.

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