
Senior Quality Assurance Specialist
Há 3 dias
This role is an individual contributor assigned to designated delivery units, sponsors, business lines, and/or specific tasks as defined by the line manager. The purpose of this role is to work with operations, global or regional quality management teams, functional teams, customers, and other stakeholders to adopt the quality plan, SOPs, and improve compliance with ICH, GCP, KPIs, regulatory requirements, and guidelines.
Quality assurance in project delivery is a critical aspect of this role, where you will collaborate with relevant stakeholders to maintain focus on quality. This includes planning and executing activities, risk assessment, and support in risk mitigation and improvement, to implement the global quality management plan within the scope of the assignment.
The successful candidate will have experience in quality management within the CRO/pharmaceutical industry and possess knowledge of medical terminology, SOPs, ICH, GCP, regulatory requirements, and quality processes. They will also understand national and international drug development regulations, and be able to travel up to 80% within the region/country.
Key responsibilities for this role include implementing the global quality management plan, collaborating with stakeholders, developing and monitoring the implementation of a delivery unit/sponsor-specific quality management and risk management plan, advising teams on GCP compliance, and supporting in managing non-compliance and quality issues according to SOPs.
Qualifications
- Bachelor's degree or equivalent
- Experience in quality management within CRO/pharmaceutical industry
- Knowledge of medical terminology, SOPs, ICH, GCP, regulatory requirements, and quality processes
- Understanding of national and international drug development regulations
- Ability to travel up to 80% within the region/country
- Strong organizational, interpersonal, communication, judgment, influencing, and negotiation skills
- Proficiency in Microsoft Office
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