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QA Officer

Major Duties and Responsibilities

• Support the Technical Agreement Annual Schedule: Ability to write technical agreements between Rosemont and Rosemont Vendors, with supervision in accordance with procedural requirements and current regulatory standards.

• Ensures Supplier Qualification/ Material Management is performed in accordance with the Regulations and local procedures.

• Support the Material management process: Creating of Material Purchasing Number codes within SAP, liaising with Manufacturers/ Suppliers regarding Change Notifications, Specifications, queries etc.

• Ability to write Supply Chain Maps and Pedigrees.

• Maintenance of Raw Material Dossiers

• Identifies, raise and reports Quality Events to the Quality Assurance Management – with execution of CAPA plans as required.

• Ability to raise, own and action Change Controls as required as part of the Supplier Qualification/ Material management process.

• Works in collaboration with other departments

• Support the Vendor Qualification process: Initiate, progress and complete Vendor questionnaires and associated documentation for new and current Vendors, as assigned.

• Revises standard operating procedures and WRKs in line with company policies and procedures.

• Supports delivery of key Quality Organisation Metrics in relation to Supplier Qualification activities.

• Ensues safety standards are met and maintained.

• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities.

•Acknowledges responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives

Competencies

• Responds promptly to requests and concerns.

• Complete business objectives

• Ensure behaviours follow company policies and departmental expectations.

• Teamwork

• Problem Solving

• Effective Communication

• Customer Service

• Business Awareness

Knowledge and Experience

Typical Years of Experience- 1-2 years’ experience

•Minimum Expected Education-Level 6 – Bachelor’s Degree

•Additional Information-University degree; typically, a minimum of 2 years experience working in a pharmaceutical GMP environment, A minimum of two ‘A’ levels or T levels in a suitable discipline.

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