Sr. Quality Engineer

Pleasanton  ‐ Onsite
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Keywords

Description

Duties
Perform Quality Assurance review/approval of validation documentation to ensure compliance with stated requirements, company standards, regulatory expectations and industry standards Serve as the Business Quality representative on cross-functional and multi-site teams as assigned Build relationships and teamwork across departments, functions, and organizations to ensure commitment and adherence to PTQ strategies and initiatives Process Change Requests related to accountable computer systems Attend project team meetings representing Business Quality. Some meetings may be outside of normal business hours in order to support a global project.

Skills
Able to decipher important details and apply a pragmatic risk based approach that maintains compliance and right to operate Understand complex situations and circumstances quickly and thoroughly Readily explain and justify compliance to procedure and regulation in a simple and coherent manner Knowledge of computer system validation according to industry standards such as GAMP5 Knowledge of computer systems used for GMP e.g. SAP, TrackWise, LIMS, etc.
Knowledge of FDA predicate rules, 21CFR Part11, and European regulations such as Annex 11 Ability to determine which information is critical and then cascade that information in an appropriate manner latterally and up to management Strong written communication skills; ability to write reports, memos, SOPs, proposals, etc.
Strong verbal communication skills; ability to prepare and deliver presentations (e.g. PowerPoint) Strong decision making regarding quality/compliance, work scheduling, allocation of resources, and managing priorities Strong knowledge of SDLC, Project Management, Change Management, Discrepancy Management SME on Computer System Validation Knowledge of manufacturing business processes

Education
B.A. or B.S degree (preferably in Engineering) and at least ten years experience in the pharmaceutical or bio-pharmaceutical industry with computer validation/quality relevant roles, three of which are at a senior level, or an equivalent combination of education and experience.
Start date
07/2014
From
Real Staffing
Published at
12.07.2014
Project ID:
740730
Contract type
Freelance
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