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Quality Internal Auditor (Shreveport) Ad id: 2611128814840683 |  Views: 49

Price: Contact Us
Date listed: 7 years ago
A global pharmaceutical company committed to providing affordable and innovative medicines for healthier lives through our three core businesses: Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products.Quality Internal Auditor The Quality Internal Auditor monitors implementation and compliance with the requirements established by the Plant's Quality System by performing internal audits. This position also participates in activities supporting Client and Regulatory audits. This position reports to the Manager I, Quality Compliance. Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): ●Performs internal audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Ensures that audit schedules are produced and communicated in a timely fashion. ●Plans, schedules, coordinates, supports, and leads detailed audits of facility practices to ensure that policies and procedures comply with worldwide regulatory agencies and Corporate Quality Policy guidelines. ●Leads/supports Client audits of the facility. Prepares for the audit/assessment activity by researching background information, including previous audit results. Assists in reviewing audit responses. Maintains the assessment file through the process to closure. ●Supports routine GMP and Pre-Approval Inspection regulatory audits. Prepares for audits by coordinating documentation, arranging facility tours, reserving conference rooms, and communicating with facility subject matter experts. May interface with regulatory inspectors during audits. ●Evaluates corrective and preventive action responses to assessment findings for adequacy, including root cause and timeliness. ●Conducts and confirms follow-up actions on Corporate, Client, and Internal site compliance audits. Reports extended corrective actions to management. Job Requirements ●Bachelor's degree required, preferably in a scientific or technical discipline. ●Minimum 3 years' experience in the pharmaceutical/biotech industry. ●Previous auditing experience preferred; ASQ and/or RAB auditor accreditation is desired. ●Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) Physical / Safety Requirements: ●Must be able to gown qualify for Grade C/D production areas. ●Duties may require overtime work, including nights and weekends ●Use of hands and fingers to manipulate office equipment is required ●Position requires sitting for long hours, but may involve walking or standing for periods of timePlease send resume and professional cover letter for review Location: Shreveport Compensation: OpenPrincipals only. Recruiters, please don't contact this job poster.Please, no phone calls about this job!Please do not contact job poster about other services, products or commercial interests.

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