Description
SUMMARY Pharmaceutical Professional 20 years' experience, Quality Assurance, auditor batch review /release, Clinical Supplies, OTC and Governance meeting manager, worked in a Consent Decree environment with special projects, audit, and review and approve label change controls folders, Bill of Materials setup, master batch records, validation documentations. label inspection/review, quality notifications, produce/update source documents used for the label process. Create and implement tracking of label change controls folders, tracking to complication label change control folder for Artwork. Special project chaired-Delisting family products projects, project management audit, formulations calculations and providing Base Business project supports for business continuity projects. ACCOMPLISHMENTS I have successful managed projects and complete timeline given on Serialization projects. Governess organization, Successful executed of governess meetings (Technical Review Forum / External Manufacturing Validation Review Committee / Product Family Ownership meetings): occur as scheduled, voting member quorum achieved, and project teams prepared multiple times a week, successfully planned and executed corporate meetings 30+employees. Deployed changes for Technical Review Forum Governess bodies developed more efficient system, alert, tracking for follow ups. I have received many merit raises for the above Highlighted skills. Successful finalized DEA paper work and had count of clinical packaging inventory. Conducted, scheduled and closed out Quality client/vendor/internal audits. Completions of audit Batch records, written and review of SOPS. I was the SME for developing the tracking of CAPA, Deviation, trending, effeteness and complaint reports along with monthly metric for Quality. Market Coordinator, (ALIM) Artwork & Labeling Implantation Management Regulatory
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