Aavis Pharmaceuticals is respected for having acquired strong capabilities for developing generic formulations and world class generic products over the years.
Quality Assurance Specialist (Hoschton, GA)
Develop and implement drug manufacturing safety guidelines and monitor product quality to ensure compliance standard and specifications with cGMP/GLP, ANDA, and 21CFR; Provide QA support for solid dosage; Review and ensure compliance of test results; Review Master Batch Records/Executed Batch Records, Change Controls; Review and approve technical documents (Process Validation, Equipment & Facility Validation), IPQA, CAPAs, SOPs, deviations, OOS, Handling of DEA documents, Provide support for all regulatory audits, internal/external inspections, and other audits.
Must have a Master’s Degree in Chemistry, Regulatory Affairs, or Pharmaceutical Science plus 1 year experience in job offered or as Formulation Associate. Require skills and knowledge in cGMP, Process Validation, batch records, SOPs, Deviations CAPAs, Change controls.
Job location: Hoschton, GA. Submit résumé referencing job code SOP001 to HR firstname.lastname@example.org, Aavis Pharmaceuticals, 9488 Jackson Trail Road, Hoschton, GA 30548.