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.