Our client is a consultancy in the food and pharmaceutical industry. They participate in very attractive projects for experienced engineers in the pharmaceutical industry. They offer challenging, varied projects with ample opportunities for personal contributions and development.
As a Quality Assurance Specialist you participate in projects related to audit and inspection management, process improvement, controlled document management and compliance management, representing QMS and taking ownership for specific tasks and deliverables. This to ensure oversight over applicable pharmacovigilance regulations.
In this role you are reporting to a QMS or Process Improvement team lead. As a member of a QMS team you contribute to the development, implementation and successful execution of strategic plans.
- Implementing and maintaining pharmacovigilance tools and processes;
- Ensuring continuous monitoring on compliance, timeliness and quality metrics;
- Reporting on metrics of pharmacovigilance processes;
- Providing feedback on performance to functional groups;
- Supporting audits;
- Acting as a member of an inspection operational team;
- Coordinating the preparation of audit/inspection responses;
- Monitoring compliance with timelines for inspection/audit responses, internal commitments and effectiveness
- Minimum of 4 years in pharmaceutical, biotechnology, or related industry;
- Minimum of 2 years work experience in a Pharmacovigilance, Regulatory Affairs or Safety Quality function;
- Preferably work experience in support of safety quality systems;
- Understanding of safety regulations and global health requirements;
- Good understanding of pharmacovigilance processes;
- Very good understanding of data management;
- Excellent communication skills and able to interact with all levels of personnel;
- Good English language skills