Location: all cities,MA, USA
Duties:
This position will support Quality Systems and Compliance functions in:
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 Blueprint 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
Education:
B.S. degree in life sciences, chemistry or engineering or equivalent and a minimum of 5 years experience in Pharmaceutical Quality or Regulatory
Languages:
English( Speak, Read, Write )
Skills:
1. Prior Experience in management of product complaints and/or adverse event process, intake, reconciliations, etc.
2. Experience with GxP regulations including but not limited to product complaint handling, patient privacy principles, document control, etc.
3. Experience with Veeva QualityDocs and Veeva eQMS a plus