Serge Shyirambere Email & Phone Number

Dublin, IE

Abbott Nutrition Division Cootehill

• Track timelines and quality of Quality Records (QR) and associated actions.
• Provide Leadership and support on the CAPA System to all plant personnel.
• Report on monthly metrics with regard to CAPA, QRs
• Review site QRs to ensure compliance with Rubric requirements and associated site and Regulatoryrequirements.

Dublin, County Dublin, Ireland

• Equipment & Utility qualification:
• Understand the V-model approach to equipment qualification.
• Generated and Executed IOQ protocols.
• Reviewed project documentation to ensure compliance of completed documentation.
• Understands the principles of ALCOA++ and how it pertains to equipment and computer systemqualification.
• Understand the requirements for clean utilities including HVAC, Water systems and CleanCompressed air.

Kigali City, Rwanda

- Evaluate human vaccines, biologicals and biosimilar applications requesting marketing authorization and making recommendations to grant and or refuse marketing authorization. - Develop and review regulations, guidelines, and SOPs related to the assessment and registration of human vaccines, biologicals, and biosimilars. - Maintain and update the register.

Kigali, Rwanda

-Screen and carry out the evaluation of applications and make recommendations to approve/or refuse for authorization of conducting clinical trials for Pharmaceuticals, medical devices and diagnostics.- Maintain and update a register of clinical trials- Develop regulatory tools (submission and review guidelines, review report templates, and SOPs) to improve.

Kigali, Rwanda

- Carry out assessments of applications requesting marketing authorization, evaluating the Radiopharmaceuticals dossier and making recommendations to grant and/or refuse the registration certificate of the product.- Develop and adopt necessary regulatory tools such as guidelines, SOPs and official forms within the regulatory framework to standardize and.

Kigali

- Facilitating Manufacturing partners obtain Marketing Authorization in Rwanda and East African Community (EAC).- Obtaining import and export licences. - Providing advice to the partner manufacturers on regulations.- Planning and undertaking regulatory inspections.- Preparing technical documents to participate in tenders. - Developing and updating standard.

Msc, Pharmaceutical Business And Technology

Bachelor Of Pharmacy - Bpharm, Pharmacy