Roche - At Roche, 94,000 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.
We are recruiting to fill the position below:
Job Title: Regulatory and Quality Assurance Trainee
Job Requisition ID: 202204-117932
Location: Lagos
Employment Type: Full Time
Job Level: Entry Level
Description
- Roche Diagnostics in Lagos is seeking a Regulatory and Quality Assurance Trainee to support the implementation and ongoing management of regulatory activities, regulatory submissions and associated activities to ensure the rapid and optimal registration for new Diagnostics products and Lifecycle Management of registered products within the West African region.
- The successful candidate will also provide support to the global temperature monitoring program within the region.
Key Responsibilities
Key Responsibilities will include amongst others:
Regulatory Submissions:
- Support regulatory activity priorities and the timing for such
- Assist in implementing regulatory activities according to the regulatory strategy to achieve the best business outcomes for Roche Diagnostics West Africa.
- Support regulatory submissions and circulating for additional internal reviews according to legislative and regulatory requirements, local, Operating Procedures (SOPs).
- Support in timely submission of final regulatory applications to health authorities in the West Africa region.
- Support regulatory activities across various areas to ensure that they are consistently completed and executed in full compliance with Roche SOPs, legislative and regulatory requirements.
Regulatory Compliance:
- Support ensuring that reference standards and GMP clearances are obtained in a timely manner.
- Support the management of import/export licensing requirements.
- Ensure that current regulatory certifications, licenses and other permits are in place.
Post Market Surveillance:
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Support product notifications (safety board notifications and quality notifications) by identifying customers affected by the notifications, communicating the notification details, facilitating that corrective action is implemented and providing feedback to the Safety Board as required.
Global Temperature Monitoring and Administration:
- Validate shipment compliance with the global temperature monitoring requirements by receiving data, analysing information, identifying areas of non-compliance and referring areas of concern for corrective action weekly and as required.
- Review consignment compliance data by receiving reports, analyse compliance with key parameters, identify anomalies, investigate reasons for anomalies, provide feedback and support implementation of corrective action as required.
Other:
- Support in the development and maintenance of regulatory resource documents. Includes SOPs, working instructions, etc.
- Ensuring that all work instructions and other regulatory information are current and accurate.
- Updating Regulatory Affairs systems with current regulatory activities, timelines and priorities. Including electronic and hard copy filings, product information submitted to health authority websites, Roche intranet and internet sites.
- Ensuring internal cross-functional teams are provided with current product registration details and other relevant information.
- Ensures appropriate support and assistance for internal/external audits.
Skills, Experience and Education
You, as an ideal candidate, will have the following skills, experience and education:
Application Closing Date
Not Specified.
How to Apply
Interested and qualified candidates should:
Click here to apply online
Note: Please submit a cover letter motivating your application as well as your academic transcripts / results.
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