Quality Assurance Specialist
4 days ago
We are seeking a highly skilled Quality Systems and Compliance Specialist to support our Quality Systems and Compliance functions. This role will be responsible for managing product complaints, regulatory inspection preparation, and document control.
Key Responsibilities- Manage product complaints, including intake, reconciliations, and reporting
- Support regulatory inspection preparation and onsite inspections as required
- Assist with document control, including archiving and revision of SOPs/WIs
- Develop and provide training on product complaint handling
- Bachelor's degree in life sciences, chemistry, or engineering, or equivalent
- Minimum 5 years' experience in Pharmaceutical Quality or Regulatory
- Experience with GxP regulations, including product complaint handling and patient privacy principles
- Proficiency in Veeva QualityDocs and Veeva eQMS a plus
Integrated Resources, Inc. (IRI) offers a dynamic and challenging work environment with opportunities for growth and development.
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