PRODUCTLIFE GROUP recrutement – QUALITY AND PROCESS IMPROVEMENT OFFICER – Tunis

The role involves to support the Head of Quality to ensure that the requirements of the corporate Quality Management System are achieved and maintained to ensure compliance with corporate policies and applicable pharmaceutical legislation.

• Management and oversight of ProductLife Corporate audit programme
• Management, tracking, follow up and closure of non-conformances, internal and external audit, inspection findings and associated CAPAs
• Maintaining a strong working knowledge of SOPs as well as ICH, GCP, GVP, local regulations and guidelines
• Maintenance, update and circulation of Quality documents including Policies, Plans, SOPs, WPDs, associated forms and templates and any other Quality documents as required
• Provide ProductLife colleagues with quality support and oversight including corrective action plans for activities not meeting quality standards
• Collaborate effectively with all ProductLife employees as required
• Management and maintenance of training compliance to support audit readiness
• Support and maintain quality activities for oversight of service providers to ensure they are functioning appropriately and audit as required
• Collation of all applicable Quality metrics
• Comply with the company’s policies and procedures to meet statutory, quality, and business requirements within the overall strategy and objectives
• All other duties as required.
• Management and oversight of ProductLife’s Quality Management System
• Manage administrative tasks pertaining to the maintenance of the Quality Management System

Education

Bachelor’s or higher graduate degree in a science related field, or equivalent experience

Experience

5 + years’ experience within a quality and / or pharmacovigilance role

Prior experience in biopharmaceutical research & development or CRO is preferred

Working knowledge of case processing, regulatory reporting process and workflow, PV and RA.

Strong knowledge of applicable pharmaceutical regulations including EU regulations and relevant

Experience with developing SOPs and department processes