Quality Assurance Associate (QMS)

My client is seeking an Quality Assurance Associate (QMS) to support the development and maintenance of the company's Pharmaceutical Quality System. This role will focus on the day-to-day processing of change controls and the generation and communication of Change Control KPIs. It will also involve managing key quality system elements including document management, supplier management, product dispositions, deviations, CAPA, and supporting Quality Management Reviews.

Key Responsibilities

• Support the day-to-day processing of Change Control, working with cross functional teams internally and with external partners to ensure change controls are progressed in line with quality agreements and procedures
• Provide feedback to the change control team on partner approvals and expected approval dates
• Ensure requested supporting information is provided to partners
• Manage the change control tracker on a daily basis
• Organise weekly Change Control meetings and ad hoc meetings as required
• Update and communicate Change Control KPIs
• Support the processing of product quality complaints
• Provide system approval of pre-approved documents as required
• Process documents through the eQMS and support eQMS administration
• Generate KPIs and support ad hoc quality projects as required
• Document handovers in the event of personnel changes or responsibility transitions

Qualifications and Skills

• 1 -2 years QMS administration experience, preferably in change control, complaints, or documentation control
• Diploma or degree in a science-based subject
• Strong organisational and communication skills
• Excellent interpersonal skills and ability to work in a busy dynamic environment
• Experience working within cross functional teams
• Proficiency in Excel and PowerPoint

The Next Step for you:

Should this position be of interest to you please submit your CV to Barry O'Mahony from Next Generation Recruitment using the apply button.

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