Quality Assurance Specialist

Training

• The production of training reports for audit
• Publication of new training courses upon request
• Maintenance of the Arriello training matricies
• Running of the monthly training reports and escalation of any training non-conformities

Auditing and Quality Assurance Communications

• Daily management of the A&QA Mailbox, assigning tasks within the departments and escalating issues appropriately

Non-conformity

• Responsible for supporting Arriello non-conformity identification, investigation, and solution proposal

Change Management (back-up)

• Support to the Quality specialist with change management reports and follow-up to actions/meetings as requested

Documentation Management (back-up)

• Support to Quality specialist with documentation management as requested

Audits/Inspections (back-up)

• Co-ordinate third-party audits on behalf of Arriello
• Co-ordinate audits performed in the company or received by the company as assigned
• Co-ordinate the Arriello internal, vendor, and Client audit program’s
• Maintainenece of a frequent finding tracker for easy access to all Arriello auditors to find appropriate referencing for audit
• Maintenance of the internal Arriello Audit schedule
• Promote audit readiness and support all employees in understanding and getting involved in audit process
• Responsible for the day to day activities of Arriello Audit CAPA management

This individual will be offered the opportunity to become a trainee Auditor when deemed appropriate within their career at Arriello and based on their own goals and ambitions. At this point, the JD will be updated to reflect this addition to their role.

Client RFI’s (back-up)

• Completion of QAQs and RFI’s as required

Other administrative activities

• Maintenance of the Quality Management System within Arriello on behalf of Arriello and it’s clients
• Agenda creation and minute taking for Team meetings
• Deviation related CAPA/finding escalation from the Arrielo QMS
• Identify needs for improvement of current processes within your role
• Ensure proper data retention and archiving of all documents used in the A&QA department.

Other responsibilities:

• Execution of activities with high quality, attention to detail and timely manner
• Effective time management and professional cooperation with internal and external partners based on transparency trust and clear communication
• Completion of the Arriello daily timesheets
• Provide back-up to the A&QA team as required

• Sufficient knowledge of Pharmacovigilance and Quality management systems and processes.
• University degree.
• Ability to manage multiple/complex tasks and challenging timelines.
• Basic knowledge of relevant regulatory standards.
• Excellent data collection and analysis skills.
• Strong attention to detail.
• Fluent English, both oral and written
• Excellent communication skills Excellent computer skills,
• Ability to work in a multi-cultural environment

• Friendly work environment
• Multinational team with 30 nationalities
• Flexible working hours, working from home
• Remote work is possible
• Cafeteria benefit system
• Dog-Friendly office