At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
We’re looking for a motivated Affiliate Quality Associate with 0-1 year of experience to join our dedicated affiliate’s PT Quality team in Roche Egypt. In this vital role, you’ll be an integral part of a collaborative team that serves as the direct contact for all product quality compliance aspects. You’ll contribute to the implementation and ongoing oversight of Roche Quality system within the affiliate, working alongside your peers to assure compliance, mitigate product quality risks and ensure the uninterrupted supply of high-quality products to our patients.
Your Impact:
Documentation & Record Management:
Maintain essential documents. You’ll also support the full lifecycle of local documents, including writing, revision, approval, implementation, distribution and archival.
Develop and maintain local procedures in compliance with the Global Pharmaceutical Quality Systems Documents.
Training Coordination & Execution:
Help define and approve the annual training plan, maintain the local training matrix and monitor the completion of assigned training, ensuring accurate record-keeping.
Verify GxP employees’ qualification status.
Actively participate in delivering GxP training sessions.
Implement and maintain the Quality System:
Maintain up to date knowledge of the relevant legal requirements and GSDP regulations.
Support the periodical review of applicable GMP & GSDP regulations. You’ll also help maintain product master data and provide general regulatory oversight.
Documentation Management.
Participate in managing complaints, recalls and returns.
Assist with the initiation, classification, assessment, remediation and closure of deviations as part of our deviation management process.
Contribute to deviation trend analysis and support continuous improvement reports.
Participate in managing local corrective and preventive actions through helping with creation, execution, follow-up and closure of records.
Dealing with internal and external inquiries about the product quality.
Change control record initiation, assessment, execution of change records.
Perform various administrative tasks to ensure smooth team operations.
Who You are:
University degree in one of the following or related scientific disciplines: pharmacy or medicine.
(0-1) year of experience in pharmaceutical manufacturing and/ or distribution domains in the area of Quality Assurance.
Basic knowledge of Good Distribution Practices (GSDP) and GxP processes, warehousing, distribution and supply chain quality guidelines (e.g. WHO guidelines).
Fluency in communication in both languages (English & Arabic).
Analytical and problem solving skills.
Planning & organizing & detail-oriented skills.
Ability to coordinate several interdepartmental activities.
Able to work with tight deadlines.
Networking with internal and external stakeholders
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.