QA Supervisor – Responsible Person

Major Duties and Responsibilities

• Qualified RP/ RPi supporting the Rosemont site in maintenance in GDP processes in line with Regulations and Rosemont procedures.

• Maintenance and improvement of Quality Production support systems (including, but not limited to the complaints and batch release processes)

• Write, implement, review and maintain SOPs, policies and other documentation for QA GMP and GDP activities.

• Continually improve the operating standards across the site whilst seeking to improve efficiency and productivity.

•Performing and reviewing internal audits to determine compliance with GMP and identify areas for improvement.

Version 1 July 2023

•Support Departments across the site on quality GMP and GDP matters.

•Perform QA Production support activities (including batch review and complaints investigations), including deputising for the QA Officer/s during periods of absence.

•Act as Quality GMP and GDP advisor on site projects such as new product introductions or CAPEX projects.

•Act as Moderator during site deviation Root Cause Analysis Investigation’s

•Act as subject matter expert during Health Authority/Customer audits.

•Host training sessions on GMP and GDP QA related topics.

•Support QA Manager in relation to site document reviews/approvals.

Competencies

•A minimum of 5 years experience within a GMP Quality Assurance environment, preferably Production Support

•Line Management Experience

•Proved track record of development, improvement and maintenance of process/ systems

•Qualified RP/ RPi

•Ensure behaviours follow company policies and departmental expectations.

•Teamwork

•Problem Solving

•Effective Communication

•Customer Service

•Business Awareness

Knowledge and Experience

• Typical Years of Experience- A minimum of 5 years’ experience.

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

• Additional Information- University Degree or equivalent. Line Management experience. Qualified RP.