Quality Management System Graduate needed at Roche

The Position

As a Quality Management System Graduate, you’ll support compliance to quality requirements as prescribed by current Good Manufacturing and Good Distribution Practices and the Roche Global Pharma Quality System. You will provide administrative support to the QA Department and maintain quality systems.

The opportunity

Quality System Management

• Initiate events in the electronic documentation management system and ensure that it is timeously allocated to an owner. 
• Track and update the destruction certificate process by tracking and following up on destruction certificates with the relevant GxP supplier and logging it against the database.
• Maintain knowledge on PQS by participating in training, reading and understanding SOPs and attending other learning platforms as required.

Release Management

• Managing and assigning products on the release register including pre-shipments.
• To prioritize preparation of release documentation by reviewing the releases prioritized list, checking for any urgent requirements within the business and implementing accordingly.

Contract Management

• Assist with oversight of service providers by monitoring compliance with the required standards.
• Coordinate reference standards with the laboratories.

Archiving

• Archive and oversee the archiving of GMP documentation by implementing the correct filing protocols, preparing and submitting complete documentation packs.

General administration and support

• Provide administrative support to internal and external stakeholders by implementing administrative functions, collecting, preparing and processing documentation requirements in line with guidelines as required.
• Create purchase requisitions for QA department for purchases by receiving the request, loading onto the system and creating the purchase requisition, monitoring and checking the receipt of goods and following up until payment is processed weekly.

Who you are

Qualifications & experience 

• NQF 5 in a pharmacy assistance or administrative role.
• Scientific or pharmaceutical background would be beneficial.
• Demonstrate evidence of maintaining and upholding rules and SOP’s

Must have knowledge of:

• GMP/GDP
• Knowledge of GMP management of documentation

Recommended skills & abilities 

• Analytical thinking
• Innovative
• Problem solving
• Accuracy and attention to detail
• Communication (verbal and written)
• Planning, Organising and Prioritising
• Situational Responsiveness