Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
MAIN PURPOSE:
To manage, maintain and continuously improve the quality functions for Roche
diagnostics across Pan-Africa.
ROLE-SPECIFIC ACCOUNTABILITIES:
Accountabilities Activities:
QMS Management and Process Documentation:
Coordinates and executes Pan African operational requirements associated with modular QMS development, implementation and maintenance.
Conduct management review of the QMS by presenting and tracking performance against standards as required.
Implement quality system in line with ISO and Divisional standards by reviewing and understanding divisional SOP, analyze their impact in the local environment and effecting relevant aspects as required.
Maintain the QMS by analyzing processes and identifying discrepancies against requirements and implementing updates as required.
Support the recalls process by liaising with distributors to facilitate recall, contacting customers and reconciling the returned goods as required.
Safety Reporting and Case Management:
To perform functions of Local Safety Responsible by working with the Networks and understanding regulatory requirements and preparing submissions, drafting reports, engaging with the health authorities, identifying queries and risks and implementing corrective action as required.
Supports developing markets with Local Safety Officer Activities in order to ensure complaint reporting and PRI/PSI identification.
Ensure vigilance requirements for adverse event reporting and product recalls are met across the networks.
Manage cases received by analysing and identifying discrepancies and take corrective action in line with Case investigation resolutions as required.
Assessing sampled cases against the required standards and supporting case owners to resolve the cases as required.
Conduct training on case management by facilitating training based the standards as required.
Risk Assessment:
Conducts risk assessments related to QMS processes and proactively address potential issues with the respective Networks
Evaluate risks associated with proposed changes to processes, products, or systems and provide recommendations for risk mitigation strategies
Continuous Improvement:
Continuously assess and improve the quality management system to enhance efficiency and accuracy across all networks.
Implement CAPA management by identifying the probable root cause, identifying the relevant corrective and/or preventative actions, executing the identified action and evaluating the effectiveness as required.
Implement new technologies and best practices to enhance the quality management system across all networks.
Collaborate with Networks in implementation of QA projects across Africa.
KEY WORK RELATIONSHIPS:
Internal External:
Roche Diagnostics (Africa Network)
International Health Authorities
Industry Associations
Contracted GMP/GDP/GLP suppliers
Network teams
Chapter teams
QA teams
RA teams
Supply Chain
ROLE-SPECIFIC REQUIREMENTS:
Qualifications & experience:
University degree in one of the following or related scientific disciplines: Pharmacy, Medicine, Pharmaceutical Chemistry, Biology or Chemistry
3-5 years’ experience in pharmaceutical/medical device/quality assurance environment
Recommended skills & abilities:
Analytical thinking
Accuracy and attention to detail
Planning, organizing and prioritizing
Communication and interpersonal skills
Good stakeholder management and the ability to effectively collaborate across a global organization
Ability to influence, act as a change agent and build consensus
Must have knowledge of:
Understanding of QMS
ISO 13485 / ISO 9001
Current regulatory framework and regulations
Systems thinker
Problem solving
Physical requirements
Ability to travel nationally and internationally
In the absence of relevant qualifications, experience in the relevant field and at the relevant level will be considered
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.