The company is a leader in the management of clinical trials since 1998. Covering Europe (France, Belgium, Germany and Spain), MENA (Tunisia, Lebanon) and North America (Canada) with more than 300 employees, the company is one of the leading mid-size CROs in Europe. Their positioning in the market is unique:
• They cover all the technical range of services for clinical research: Regulatory Affairs, Clinical Operations, Biometrics, Pharmacovigilance, Medical Writing, Quality Assurance.
• They benefit from the expertise of the mother company to propose innovative solutions and IT tools.
• They manage their projects with a fully integrated QA system, based on KPI and risk management tools.
The company offers four business lines to meet all the clinical development needs:
• Project Development Services: An international CRO with expertise covering all stages of development (pre-clinical to Phase I to IV).
• Functional Services Provider: Near shore and offshore service centers, a tailor-made offer according to projects.
• Consulting: Covering worldwide needs from their main sites in France, Belgium, Canada and Lebanon.
• Real World Evidence: Providing the full set of services for real-life data collection and analysis.
In collaboration with the client's management, the QA officer solid dosage form (who acts as a consultant) is responsible for setting up and maintaining an effective QMS.
The QA Officer:
• Ensures that operations related to the production of pharmaceutical drug products are in accordance with national and / or international regulations and guidance (GMP) as well as the company's quality policies.
• Ensures that registered pharmaceutical drug products are produced and supplied to markets in accordance with the company's quality standards.
• Proactively helps operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements.
• Communicates with internal and external clients: production, QC, RA,supply chain, development, purchase, validation, engineering.
• Daily monitoring of quality incidents, investigations, change control, CAPA.
• Review and approval of manufacturing and quality assurance procedures.
• 2 years minimum experience in QA in pharma.
• Knowledge of tablet manufacturing techniques (compression).
• Knowledge of GMP and cGMP regulations.
• Able to make evidence-based decisions and take responsibility for them.
• Knowledge of written and spoken English.
• Good oral and written communication skills.
• Relational skills to work in a team.
• Stress resistant.
• Ability to solve problems and provide constructive and innovative solutions.
• Ability to work in the field with producers.