Regional Quality Manager, East Africa at
1 month ago
The Opportunity1
Roche in Kenya has a vacancy for a Regional Quality Manager for the East Africa region who will ensure the maintenance and continual improvement of the Affiliate's quality system, in order to ensure compliance with the regulations and Roche requirements.
You as our successful candidate will support in overseeing warehousing and distribution partners within the East Africa region regarding the implementation, utilization and continual improvement of the quality system, in order to ensure compliance with the regulations and Roche requirements, and an uninterrupted supply of quality products to the patients.
Key ChallengesRegional Warehousing and distribution partners:
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.Pharmacies, Hospitals and other involved service providers:
Realize training needs and execute accordingly
Other:
Support in preparation and facilitation of regional workshops
Monitor health authority trends and discussions for the countries within the region
Implement and Maintain the Affiliate Quality System
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.
Ensure an uninterrupted supply of the products to the market.
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.
Management of GxP Out-sourced activities.
Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution)
Perform audits of contracted third parties.
Who you Are as our ideal candidate:
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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