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The Position
We’re looking for a motivated Affiliate Quality Associate 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
Lead the selection, implementation and decommissioning of GxP suppliers.
Provide ongoing quality support and management of all outsourced operations.
Monitor and enforce GxP supplier adherence to Quality Agreements using KPIs, audits and CAPA follow-up.Ensure an uninterrupted supply of the products to the market:
Release commercial product batches to the local market according to local regulations, marketing authorizations.
Ensure compliance with GSDP guidelines and regulations for the products distributed locally.
Ensure batch traceability for all batches received and distributed by the local warehouse.
Ensure appropriate supervision of the supply chain, and existence of additional controls for the cold chain.
Offer continuous GxP support for warehousing and distribution functions, such as storage, inventory, and transportation temperature monitoring.
Perform final product release for compliant batches
Oversee local redressing activities, including the revision and approval of records affecting regulatory information.
Manage product destruction processes from quality point of view.
Review physical returns inspection results and determine the final disposition of returned products & implement and maintain the Quality System:
Maintain up to date knowledge of the relevant legal requirements and GSDP regulations.
Documentation Management.
Develop and maintain local procedures in compliance with the Global Pharmaceutical Quality Systems Documents.
Participate in managing complaints, recalls and returns.
Handle deviations, investigations and action plan follow-up.
Participate in managing local corrective and preventive actions.
Quality Risk Management planning, identification, quality risk took fill-out and follow-up including interactions with third parties.
Dealing with internal and external inquiries about the products quality.
Contribute to the definition and approval of the annual audit plan.
Who You are:
University degree in one of the following or related scientific disciplines: pharmacy or medicine.
(2-3) years of experience in a 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.