What are the responsibilities and job description for the Quality Systems and Compliance Contractor position at Integrated Resources, Inc ( IRI )?
- Management in product complaint handling including but not limited to: Intake of Product Complaints from the secured access mailbox Perform weekly and monthly product complaint reconciliations with vendors, partners, affiliates and Drug Safety & Pharmacovigilance Assist in providing product complaint metrics reports Develop training on product complaint handling Assist with revision of product complaint SOPs/WI Archive product complaints in accordance with policies
- Act as a QS&C document control back-up support
- Will support regulatory inspection preparation and onsite during inspections as required.
- This position will be a hybrid role including both remote and onsite days
- Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.
- Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.
- Experience with Veeva Quality Docs and Veeva eQMS a plus
B.S. degree in life sciences, chemistry or engineering or equivalent and a minimum of 5 years’ experience in Pharmaceutical Quality or Regulatory
