Quality Assurance Specialist Job Roche

AI summary

Roche is hiring a Quality Assurance Specialist in Nairobi on a contract basis. The role involves maintaining the quality management system, implementing CAPA, conducting audits, ensuring GxP and ISO compliance, and training personnel. Ideal for candidates with QMS and regulatory compliance experience.

• Contract role with Roche in Nairobi
• Responsible for QMS maintenance and CAPA implementation
• Requires knowledge of GxP regulations and ISO standards
• Includes product complaint management and batch release

Description

Home » Jobs In Kenya » Quality Control Jobs In Kenya » Quality Assurance Specialist Job Roche Job Title: Quality Assurance Specialist Date Posted: 17/07/2026 Job Type: Contract Job Level: Middle Employer: Roche Industry: Quality Control Salary: Open Location: Nairobi Country: Kenya Deadline: 31/07/2026 Summary: Quality Control Jobs, Roche Jobs. Looking for a quality control job in Kenya? Roche is hiring a Quality Assurance Specialist in Nairobi, skilled in QMS maintenance, CAPA implementation, and GxP regulatory compliance. Objective(s): 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 distributor(s) 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 Qualifications 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 Click here to apply 🎯 Applying for This Job? Don’t Send a Generic CV. Don’t send the same CV to every job/employer. Have our recruitment team customize your CV to match the requirements of this specific job and improve your chances of getting an interview. Customise My CV For This Job . ⭐ 5-Star Reviews . Job Seeker Testimonials: Professionals Who Got Jobs Through Cor