QA Officer – Supplier Relations

QA Officer – Supplier Relations

Ensures Quality Assurance activities are planned and executed in line with Rosemont SOPs and GMP Requirements and Regulations

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.

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