Deja B. Email & Phone Number

•OTC/Cosmetic, Drug Development, Medical Device and GCP.• Documentation management •Change Management •Cleanroom Environment, Water, Raw Material & Components, and Product testing experience in a GMP regulated industry•Data analysis and trending•Strong communication skills, both oral and written•Technical writing skills •Good interpersonal skills•Strong focus on developing an organizational culture that fosters teamwork•Ability to work in a fast paced environment•Ability to work well under pressure and maintain positive and enthusiastic attitude • SAP•Microsoft office (Word, Excel and PowerPoint). eDMS. TrackWise . Veeva QualityDocs/ QMS. Agile. Compliance Wire/ALTOS LMS. Brainshark LMS . OOS/Deviation/CAPA/Quality Related Investigations/Pharmacovigilance• Knowledge of industry standards and regulatory requirements: (including but not limited to: 21 CFR Part 210/211 & 280, USP 71, USP 1113, USP 1116, USP 797, USP 1211, USP 1111, USP 788, USP 61/62, USP 85, USP 161, USP 1231, USP 51, ISO 9001/13485)•OTC/PO Reconciliation/Inventory management •Able to drive compliance with all industry and regulatory requirements. •Participation in continuous improvement initiatives.•Ability to teach and train others effectively