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Quality systems enhancement specialist

Ballina
beBeeQuality
Posted: 23 August
Offer description

Quality Assurance Professional


The Role:

As a Quality Assurance Professional, you will play a crucial role in enhancing the client's Quality Management System, supporting the production of life-saving medicines and therapies for global pharma. Your primary focus will be to ensure that QMS processes are efficiently maintained and conform to internal and external client requirements.


Key Responsibilities:

* Collaborate with cross-functional teams to enhance the Quality Management System and support our client's processes. This includes tracking and reporting metrics and key performance indicators, identifying value-added improvements, and reviewing Corrective and Preventative Actions (CAPA).
* Collaborate with commercial and technical operations teams to deliver QA objectives and support business growth.
* Track and report metrics and key performance indicators for the Quality Management System.
* Identify and support value-added improvements and key performance indicators with stakeholders.
* Review and follow-up on open actions related to CAPA, OOS reports, and Deviations.
* Support and host client quality audits, addressing findings and required actions.
* Manage the Internal Audit program, including coordinating audit schedules, reviewing findings, and providing insights to drive continuous improvement.
* Develop innovative solutions to add value to team deliverables and identify opportunities for improvement.
* Assist in developing systems and processes to ensure delivery of information across functions.
* Document Control - Manage SOPs and Document Control.
* Manage quality training programs to ensure effective mirror of HQ processes.
* Lead training compliance to SOPs.
* Perform other duties as required to support the growing Quality organisation.


Requirements:

* Minimum 3 years of professional experience in pharmaceutical industry Quality Assurance role.
* Adept at multi-tasking and working in fast-paced environment.
* Strong communicator both internally and externally with pharmaceutical clients.
* Bachelor's degree in science, engineering, or business preferred.
* Willingness and availability to travel on company business.
* Team Oriented: Ability to integrate with organisational Core Values, culture, and team climate.
* Detail Oriented: Ability to focus on details while understanding overall direction.
* Self-Motivated: Identify what needs to be done and do it before being asked or before situation requires it.
* Results Driven: Focus on desired result, set challenging goals, and meet or exceed them.

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