SQAFYI - Software QA Resource - FYI

US-CA-Corona: Quality Assurance Engineer

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Date: 28-Sep-2010

Quality Assurance Engineer

• Identifies deviations from SOP’s and cGMP’s. Directs the proper investigation, resolution and conditions of approval. • Directs the QA function related to sampling of raw materials, in-process and finished goods, sampling and inspection of labeling testing packaging components, statistical inspections in- process, in-process segregation of suspect/rejected material and maintenance of approved supplier lists. • Directs the management of systems for deviations including identification, investigation, resolution, tracking and follow-up deviations. Approve deviation investigations and define conditions for approval. • Maintain a system for security of cGMP and other documents to comply with company and regulatory record retention requirements. • Direct the Quality Assurance functions to ensure that all laboratory, production and raw material supplier records are audited in compliance with company and regulatory requirements release/reject raw materials, packaging components and finished product based on these audits. • Interfaces with state and federal regulatory agencies. Participates in Corporate, state, FDA and third party compliance audits. • May be responsible for the timely and compliant investigation and closure of product complaints from the field. • Makes recommendations relating to potential methods in resolving production and packaging quality systems. • Analyzes, prepares and monitors department budget. • Current cGMP’s, SOP’s, FDA, EMEA and other regulatory requirements. • Personal computer hardware and software applications • Business English usage, spelling, grammar and punctuation • Principles and practices of managing Quality Assurance programs • Principles of mathematical and statistical computations • Chemical analysis and instrumentation • Principles and practices of budget preparation and administration • Pharmaceutical principles and practices and their application • Recruiting, interviewing, and selecting applicants in accordance with established employment practices and methods • Managing, directing and coaching a team of QA and QC professionals in the investigation and resolution of deviations. • Working with regulatory agencies through the audit review process.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-CA-Corona: Quality Assurance Engineer