Quality Systems Engineer
This role supports the Quality Systems Manager and will include implementing & maintaining the Quality Management System in accordance with applicable standards and regulations.
Responsibilities:
- Be a key driver of cGMP practices within Quality and Operations
- Be the 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 other Quality processes and implement 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
Educational Requirements:
- A primary degree in a Science/Engineering discipline
Relevant Experience:
- A minimum of 5 years work experience in the Medical Devices Pharmaceutical regulated environment working within an established Quality System
- Proven experience leading CAPAs and Internal Audits
- Strong problem solving ability
- Experienced in technical writing and review with good attention to detail
- Proven ability of working on own initiative and in a cross-functional team environment
- Excellent interpersonal and communication skills
- Ability to prepare and present data effectively
- Qualified Internal Auditor experience