Regional Quality Manager, East Africa at Roche Kenya

• Support selection of new partners by active assessment support during the due-diligence phase.
• Oversee closing of gaps and adherence to long-term Compliance Plans.
• Act as a first-level support for warehousing and distribution partners concerning quality-related topics including temperature excursions, complaints and issues which can also be handled directly via the respective communication channels).
• Oversee the implementation, utilization and continual improvement of the quality system at the 3rd party during the manage phase.
• Execute trainings with individual partners based on their specific needs.

• Realize training needs and execute accordingly

• Support in preparation and facilitation of regional workshops
• Monitor health authority trends and discussions for the countries within the region

• Maintain up to date knowledge of the relevant functional, legal and GMP/GDP requirements.
• Documentation Management- Develop and Maintain local procedures in compliance with the Global Pharmaceutical Quality System Documents.
• Perform Self Inspections.
• Manage Planned (Changes, CAPAs) and unplanned events (Complaints, Recalls, Deviations and Returns).
• Training of personnel involved in GxP activities.
• Quality Risk Management.
• Dealing with internal and external inquiries about product quality.
• Qualification of distributors and customers.

• Release commercial product batches to the local market and Investigational Medicinal products to the local clinical investigation centers, according to the local regulations, marketing Authorizations and Clinical Trial Authorization.
• Ensure compliance with GDP 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.

• Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution)
• Perform audits of contracted third parties.

• You hold a university degree preferably in one of the following or related scientific disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology. Any other university degree can be considered with a proven record of work experience in the pharmaceutical industry working closely with warehousing and distribution partners (e.g. regulatory, supply chain, commercial operations).
• You have at least two years of experience in Quality Control and/or Quality Assurance in a pharmaceutical environment of an affiliate, direct market country or sub-regional center dealing with warehousing and distribution partners.
• You have basic knowledge in pharmaceutical packaging/redressing operations.
• You have experience in the areas of Quality Control and/or Quality Assurance.
• You exhibit excellent written and oral communication skills, analytical and problem solving skills and a high degree of proficiency in English.

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