Affiliate Quality Associate

Job Description

The PositionSummaryYou will be part of the affiliate?s GxP team concerned with serve as the direct contact for all product Quality compliance issues in Roche Egypt. The affiliate quality is the privileged resolution. The role and responsibilities include the implementation and ongoing oversight of the application of Roche?s Quality System within the affiliate, in order to assure compliance with internal and external regulations as well as preventing any negative impact on product quality/patient safety.Your ResponsibilitiesPeople and Organization:

• Achieve quality compliance in the Affiliate through strong partnership between Global Quality, Regulatory Affairs, Medical and other Affiliate functions
• Set up and assess the quality culture within the affiliate under leadership of Egypt leadership team
• Identify and utilize resources within the Affiliate for the effective and sustainable deployment and ongoing management of the Quality System

Quality System and Business Process:

• Contribute in the deployment of all applicable Quality Systems within the Affiliate with the support of Global Quality Supply Chain & Distribution
• Act as the local learning expert for GxP related topics
• Quality Performance: Contribute in on going effectiveness assessments for all deployed Quality Systems in the Affiliate
• Third Party Management: Oversee (from a quality perspective) managed third party contactors, manufacturers, local packaging/labeling partners and distribution centers. Ensure Quality Agreements are in-place where necessary and their requirements are met
• Quality Compliance Excellence
• Quality Product Issue Resolution: Clear and timely communication/action plans for issue resolution with appropriate escalation, communication, investigation of associated corrective & preventative actions and closure
• Regulatory Excellence: Ensure sustainable Quality/Regulatory excellence through systems, science, people, and continuous process improvements
• Maintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations
• Documentation management
• Develop and maintain local procedures, in compliance with the Global Pharmaceutical Quality System Documents
• Plan, execute and follow-up self-inspections and 3rd party audits
• Manage Complaints, Deviations and Investigations. - Manage Returns, Damages and Expiries
• Manage Change Control
• Manage local Corrective and Preventive Actions
• Dealing with internal and external inquiries about the products quality

Ensure an uninterrupted supply of the products to the market:

• Release commercial product batches to the local market according to the local regulations and Marketing Authorizations
• Ensure compliance with GDP guidelines and regulations for the products distributed locally
• Ensure compliance with GMP guidelines and regulations for the products manufactured 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
• Drive continuous improvement and training activities with key stakeholders (partners, hospitals, HCP?s, etc.) in the market relating to GxP topics.

Who You Are

• You hold a University degree in one of the following or related scientific disciplines: pharmacy and/or medicine
• You have at least five years experience in a pharmaceutical manufacturing and/or distribution domains in the areas of Quality Control and/or Quality Assurance
• You possess deep knowledge in GxP processes, warehousing, distribution and supply chain quality guidelines (e.g. WHO guidelines)
• You demonstrate a high ethical standards in all business dealings
• You are able to ensure and adherence all safety, security, and protect health and the environment at our workplace to the best of our knowledge, ability and experience
• You are capable of continuously and adequately identify, assess and manage compliance risks that fall within the sphere of our business responsibilities
• You possess strong analytical and problem solving skills
• You demonstrate leadership and has proven track record in business success
• You have strong English and Arabic communication skills both spoken and written

Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we?ve become one of the world?s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.Roche is an Equal Opportunity Employer.

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