Clinical Supplies Complaint Coordinator
hace 3 semanas
We are seeking a skilled Clinical Supplies Complaint Coordinator to join our Clinical Research and Pharmacovigilance team. This role is critical in the clinical supplies chain, responsible for timely evaluation, stability assessment, and disposition of impacted clinical supplies.
As a Clinical Supplies Complaint Coordinator, you will interact directly with clinical sites to obtain complete temperature excursion data and provide disposition of impacted clinical supplies. Your role will work closely with Global Clinical Supplies, the Global GCD Clinical Supplies Lead SME, and several roles in Quality and Continuous Improvement (QCI).
Primary Responsibilities:
- GCP clinical supplies complaint intake, evaluation, product impact assessment, and disposition of clinical finished good supplies impacted by temperature excursion
- Manage GCP clinical supplies complaints in centralized system and ensure complete documentation
- C coordinate and/or support the preparation of procedures, processes, and quality improvement activities
- Initiate GCP clinical supplies investigations for GCTO Country Ops to complete
- Provide support for metrics compilation that are presented at various governance councils
Your Profile:
- Bachelor's degree, technical emphasis in an appropriate scientific or engineering field preferred
- 2 years of post-degree experience in the Pharmaceutical or equivalent industry – in Good Clinical Practices (GCP) or Good Manufacturing Practice (GMP) related field, including Technical, Engineering, Quality, or Operations
- Effectiveness and creativity in approaching and solving technical problems
- In-depth working knowledge of clinical supplies complaints or GCP related regulatory requirements for supplies as they apply to the pharmaceutical field or a related area
- Basic understanding of MS Office applications
- Evidence of leadership skills coupled with highly developed oral and written communication skills, effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
- Demonstrated teamwork skills and the ability to work independently
- Attention to detail, flexibility, and an awareness of production and quality control problems
- Ability to adapt in a changing working environment
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