836 Operational Quality Assurance Officer

Since 1993, ProductLife Group (PLG) has supported customers throughout the life science product lifecycle, combining local expertise with global reach and covering more than 140 countries.

PLG is a life sciences consulting firm that offers outsourced services in the areas of regulatory affairs, quality and compliance, vigilance and medical information. Our expertise extends to both established product monitoring to innovative therapies and diagnostics.

 

We are looking for an Operational Quality Assurance Officer for our Tunisia team.

 

Responsibilities

• Defining and proposing a quality policy and objectives to the general management.
• Implementation of the quality policy within the company’s quality system.
• Implementation and validation of quality tools according to their evolution.
• Implementation of process compliance checks in relation to the reference documents.
• Setting up, developing and maintaining the quality system in accordance with internal and regulatory requirements.
• Implementation, maintenance and validation of the quality manual.
• Leading the annual quality review and drawing up/disseminating the minutes.
• Participation in the change management committee.
• Implementation and validation of quality systems according to their evolution.
• Validation of the transversal and periodic analysis of the results of the quality indicators.
• Development of the internal/external audit program.
• Participation in the preparation of audits/inspections.
• Participation in audits/inspections.
• Definition of training guidelines within the quality department.
• Participation in the integration of newcomers.
• Participation in the development of initial and ongoing internal training plans based on the training matrix for validation by the heads of the divisions and/or department directors concerned and monitoring of internal training in collaboration with the operational staff.

 

Required skills

Education

• Master 2 / PhD

Experience

• A first experience in a pharmaceutical industry as a Quality Assurance Officer (excluded internships and apprenticeships)
• At least 2 years of experience

Languages

• French and English mandatory

Technical skills

• Knowledge of deviation processing, implementation of CAPA, GMP and FDA knowledge, monitoring of quality indicators