Job Description

You will be responsible for supporting the Quality Control Department in the management of department documentation, and support of the QC functions through various administrative duties, ensuring that objectives are effectively achieved, consistent with the company requirements to ensure compliance.

• Supporting the management of QC documentation including archival of executed protocols, true copy of executed protocols/reports/documents, authoring/updating QC SOP’s and data compilation/review and data verification as directed
• Support for preparation of trend reports
• Coordination and management of QC eLogs
• Support for 5S, housekeeping and audit readiness for QC Labs
• Placing purchase orders for non VMI QC lab reagents and coordination/payment of associated invoices
• Management of purchase orders and associated activities related to budgets and expense reporting
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Responds to non-standard requests from customer needs.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Scheduling, coordinating and monitoring appointments for department managers

Required Knowledge, Skills, and Abilities

• A minimum of 3-4 years’ experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations
• Knowledge of EU/US quality related pharmaceutical regulations
• Basic computer literacy
• Strong communication and organisational skills
• High level of technical aptitude & motivation
• Demonstrated ability to take initiative and attention to detail
• Good presentation skills.
• Excellent knowledge of relevant Quality and GMP Compliance Guidelines
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent