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 

Qualification:

• 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.