Quality Assurance Specialist Ghana at Roche

Summary

Ensures license to operate for the affiliate distribution activities by driving all activities to achieve compliance with Roche PQS requirements as well as applicable local regulations.

Releases products received from Roche distribution hubs for domestic distribution and actively follows up on any detected discrepancies.

Your Responsibilities

• To implement a quality system in line with Roche PQS requirements, local GxP-regulations as well as applicable ISO-standards
• To maintain the QMS
• Change control
• To implement CAPA management
• To conduct management review of the QMS
• To conduct quality risk assessments
• To manage data integrity by implementing relevant SOPs and documentation practices, reviewing data and documentation, identifying discrepancies and implementing corrective action
• To lead quality audits by performing self-inspections, performing external audits, identifying audit queries, drafting audit reports, engaging with the relevant parties to implement corrective action and following up on agreed actions in line with the audit plan
• To lead the recalls process on affiliate level by liaising with the GxP-suppliers as well as customers and local Health Authorities to facilitate recall, contacting customers and reconciling the returned goods as required
• To perform the annual product quality review by implementing the SOPs in line with the plan and drafting the summary annually
• To maintain knowledge on PQS by participating in training, reading and understanding SOPs and attending other learning platforms as required
• To liaise with internal and external stakeholders by providing input on quality standards and procedures
• To plan and execute internal GxP-trainings as well as for external bodies such as service providers, customers, HCP’s and local authorities as well
• Product complaints and Inquiry management
• Product release
• To support the supply chain performance by monitoring the 3PL quality KPIs

Qualifications And Skills

• University degree in one of the following or related scientific 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
• Excellent knowledge in Regulatory Framework and Regulations, Quality Assurance as well as Quality Management within pharmaceutical environment plus applicable ISO Standards for Medical Devices
• Analytical thinking
• Innovation
• Problem solving
• Accuracy and attention to detail
• Communication (verbal and written)
• Accountability
• Planning, Organizing and Prioritizing