Quality Assurance Specialist
1 day ago
The successful candidate will be responsible for managing the day-to-day processes of complaint management activities, ensuring customer service, compliance and efficiencies.
- Perform reconciliations with stakeholders, e.g. NPS and MedInfo, and respond to clients with the final outcome of complaints.
- Prepare Quality trends, evaluate and support the team in driving Continuous Improvement for processes and product quality performance.
- Maintain local Quality Systems and Standard Operating Procedures for all GxP related activities, ensuring compliance with cGMP through training and internal audits.
- Collect, monitor and report Quality Key Performance Indicators (KPIs) for management reporting.
- Assist in Health Authority inspections and internal audits by supplying information and documentation in a timely manner.
- Support and track the implementation and maintenance of the local Quality system in accordance with the Quality Manual.
Key Responsibilities:
- Manage processes and systems for all GxP Quality Assurance, e.g. Change control, Training Management, Escalation Management, Risk Management.
Requirements:
- Proven experience in Quality standards and assurance, with ability to design into work activity and achieve.
- Strong understanding of departmental objectives, including support of projects with agreed quality and delivery date, passing of internal and external inspections.
Qualifications:
- Bachelor's degree in a relevant field, such as Quality Assurance or a related discipline.
- Relevant certifications, such as CQI or equivalent.
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