Quality Systems Specialist

About the Company

About the Position

Key Responsibilities

• Be a key driver of cGMP practices within Operations and Quality divisions
• Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements
• Ensure adherence to internal and external regulatory requirements
• Be an active member of the internal audit team and support external audits at the site
• Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA
• Prepare and present data to management on quality system performance
• Drive thorough investigation & root cause analysis of CAPAs and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence
• Support process improvement activities
• Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required

Experience/Requirements

• A primary degree in a Science/Engineering discipline
• A minimum of 5 years work experience in the Medical Devices Pharmaceutical regulated environment working within an established Quality System
• Qualified Internal Auditor experience
• Proven experience leading CAPAs and Internal Audits
• Strong problem solving ability
• Experienced in technical writing and review with good attention to detail
• Excellent interpersonal and communication skills
• Ability to prepare and present data effectively

Remuneration Package

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