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Our client are seeking a meticulous and proactive Quality Technician to join their team and ensure our processes meet regulatory requirements and industry standards.
Key Responsibilities:
Quality Management System:
- Issue controlled forms and logs.
- Manage review periods for controlled SOPs, ensuring timely reviews.
- Raise and implement change controls and assist with artwork change controls.
- Raise deviations and implement CAPAs.
- Maintain databases, files, and records.
- Assist with internal principle-based audits.
Release Process:
- Review batch documents and release batches, including physical release.
- Prepare Certificates of Analysis.
Equipment and Environment:
- Assist with temperature mapping as required.
- Arrange annual calibration and validations according to schedule.
- Maintain stability cabinets/HVAC and liaise with engineers/suppliers for maintenance and performance verification.
- Perform regular walkabouts of facilities, making recommendations for continued compliance.
Complaint Handling:
- Receive, log, and investigate complaints.
- Maintain a database and conduct trend analysis of complaints for monthly reports.
Miscellaneous:
- Assist with training where appropriate.
- Perform any other work reasonably required by the QA Manager or Company Directors.
General Duties:
- Report any health & safety or employment regulation transgressions immediately.
- Adhere to health & safety rules and procedures, including the use of applicable PPE.
- Follow relevant rules and procedures to ensure compliance with quality management systems.
???????Qualifications:
- Proven experience in quality assurance or a related field.
