QA Officer – Supplier Relations
Ensures Quality Assurance activities are planned and executed in line with Rosemont SOPs and GMP Requirements and Regulations
• Acknowledges responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives
Supplier Relations:
• Technical Agreement, Supply Chain Map/ Pedigree and template Risk Assessment Author
• Excipient Risk Assessment Author
• Material management process: Creating and Release of RM codes within SAP, liaising with Manufacturers/ Suppliers regarding Change Notifications, Specifications, queries etc.
• Maintenance of Raw Material Dossiers
Quality Systems:
• Document Issuance/ obsoletion and Control
• Archiving
• PQR Author
• FAQ/ Customer Queries and Third-Party Notifications (QMS)
• Generate Site KPIs
Production Support
• AQL, DOMs, Pallet Checks
• Batch record review
• Excipient Risk Assessment Author/ Compliant initiator and investigator
• Technical Agreement Author
All:
• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities
Major Duties and Responsibilities
- Ability to write Quality documents and reports with supervision in accordance with procedural requirements and current regulatory standards.
- Works in collaboration with other departments
- To communicate instantly any problems/queries to QA Supervisors/ QA Manager
- Identify issues and problems during QA activities, raising deviations if required and ensuring timely closure.
- Supports quality events investigations/ root cause analysis.
- Revises standard operating procedures and WRKs in line with company policies and procedures.
- Supports delivery of key Quality Organisation Metrics in relation to QA activities
- Raise and progress Change Controls as required.
- Complete CAPA and assigned actions as required.
- Completes statistical analysis as per the in-house procedures (PQR).
- Ensues safety standards are met and maintained
- Support Internal Auditor
- Ensure compliance to MHRA, FDA, Regulatory and Company requirements / standards
- Provide relevant solutions and proposals to facilitate any decision-making processes.
Competencies
- Responds promptly to requests and concerns
- Complete business objectives
- Ensure behaviors follow company policies and departmental expectations
- Teamwork
- Problem Solving
- Effective Communication
- Customer Service
- Business Awareness
- Time Management
Knowledge and Experience
- Typical Years of Experience-1 -2 years experience
- Minimum Expected Education- Level 6 – Bachelor’s Degree (or relevant on the job experience)Minimum Expected Education-
- Additional Information- University degree; typically, a minimum of 2 years experience working in a pharmaceutical GMP environment of which, at least 1 years’ experience is in pharmaceutical QA.
A minimum of two ‘A’ levels or T levels in a suitable discipline.