Quality Assurance Specialist At Acino Egypt
Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region and Latin America, and operate in some of the most dynamic countries of the world. We value courage, commitment, trust and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.
This role is based in Cairo, Egypt and will report directly to the QA Manager. The role will be responsible for all Quality-related activities in Egypt.
Your responsibilities will be:
Qualified Person (QP) according to the Egypt legislation for Acino Egypt.
Creation of QP declarations and statements.
Responsible for all Quality-related activities in Egypt.
Establish and implement the Quality Management System (QMS), Technical Quality Agreements (TQAs) and all other Quality related documents.
Support the maintenance and improvement of external supplier quality oversight including supplier qualification, supplier risk management, and audit planning process: scheduling, execution, and follow-up on GMP/GDP audits.
Perform tasks as a Qualified Person in accordance with local regulations and Acino standards for the manufacture and testing of externally manufactured medicinal products.
Create and maintain the local Quality Management System (QMS) including Master documents, SOPs etc.
Create/approve 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.
Monitor and report monthly KPIs such as audit execution vs plan, implementation of QMS.
Keep up to date with the relevant regulations and guidelines.
Perform the batch release of products according to internal SOPs (SAP system).
Assessment of PQRs.
Ensure compliance with the 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.
Your Profile:
Education in Pharmacy, natural Sciences or relevant discipline.
3-5 years professional experience in Quality Assurance in the pharmaceutical industry.
Experience of working in a cross-functional environment.
Strong communication and influencing skills to be able to communicate (verbal and written) technical and non-technical information clearly to business partners and drive the decision-making.
Good understanding and knowledge of GxP regulations (EU, FDA, WHO etc).
Experience in preparation and execution of GxP audits
Experience with electronic systems (SAP, Track wise).
High analytical and process-oriented mindset combined with the capability of understanding complex situations and processes.
Able to work in an international and interdisciplinary environment.
Excellent command of English (spoken and written).
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