Company: Roche Kenya
Location: Nairobi
Job Type: Full Time
Apply Before: 2026-08-04
Job Description
JOB OBJECTIVEs:
To maintain and continuously improve the afliate quality system in compliance with Roche Pharmaceutical Quality System requirements, local GxP-regulations and applicable ISO-standards whilst ensuring an uninterrupted supply of quality products to patients.
Key Responsibilities
To conduct regular management review of the QMS by presenting and tracking performance against relevant standards
To implement quality system in line with ISO/relevant standards by reviewing and understanding divisional SOP, analyse their impact in the local environment and effecting relevant aspects as required
To identify discrepancies and investigate them via the available quality systems in a timely manner
To identify and manage changes to processes, persons or systems, evaluate its impact and affected parties, implement planned actions and communicate as required
To implement local CAPA management by identifying the probable root cause, proposing relevant corrective and/or preventative actions, executing the identied action and evaluating the effectiveness as required
To conduct quality risk assessments using the quality risk assessment tools , identify risk areas, implementing risk mitigation/elimination measures,and monitor changes as required
To ensure data integrity by creating, maintaining or implementing relevant SOPs
To initiate or support quality audits by performing self-inspections, external audits. Identify audit queries, draft audit reports, engage with the relevant parties to implement corrective action and follow up on agreed actions
To initiate annual mock recall and support actual recall process by informing the Health authority, liaising with the distributors to facilitate product recall, contacting customers and reconciling the returned goods as required
To maintain up to date knowledge of PQS by participating in physical trainings or provided in virtual learning platforms as required
To perform training of personnel involved in GxP activities
To maintain systems for reporting product complaints, including monitoring of the generic product complaints mailbox on business days
To manage all complaints received based on the the applicable SOP
Release commercial batches to the local market, and where applicable, Investigation Medicinal Products to the local clinical trial sites, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
To ensure all required KPI’s in the product release process are met and feedback is provided as required
To support the returns process by implementing the relevant SOP, Ensure compliance with GDP guidelines and local regulations for the products distributed to the market
Support batch traceability for all batches received and distributed by the local warehouse
Coordinate with the supply chain responsible to manage additional controls for cold chain management
To support the identication and selection process for GxP suppliers To create and maintain quality agreement with the GxP supplier To assist with oversight of warehouse and distribution business partners by
monitoring compliance with the required standards stipulated in the quality agreement
To ensure implementation of the SOPs, identify areas of concern and address these with the service providers until resolved.
Perform audits and assessment of contracted third parties
To liaise with internal and external stakeholders by providing input on quality standards and procedures, liaising with them on procedures and building skills in the quality standards and procedure requirements as required
WHO ARE YOU?
University degree in one of the following or related science disciplines: pharmacy, medicine, pharmaceutical chemistry and technology, or biology
3 – 5 years’ experience in pharmaceutical or medical device environment, Regulatory and Quality Assurance Management
Demonstrate evidence of maintaining and upholding rules and SOP’s
Must have knowledge of:
Current regulatory framework and regulations
Quality assurance and Quality Management within pharmaceutical environment
ISO Standards
How to Apply
Interested and qualified? Go to Roche Kenya on careers.roche.com to apply
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Source: MyJobMag