Auditor, GMP

Certified Quality Auditor (Compliance) This position is in our Compliance/Quality Systems Department and is responsible for supporting the annual planning of Internal and Supplier (Material & services) audit schedules. The individual in this position will be responsible for supporting and performing internal and supplier audits of the manufacturing, laboratories and services areas of Leiner Health Products and any other locations as required. Other responsibilities include: Prepare and distribute audit reports to the audited areas. Maintain access control of audits and confidential documents. Coordinate meetings for discussion of audit reports & establish correction and prevention action plans with management. Maintain oversight of the corrective action plan and assure that the corrective actions are completed and/or updated accordingly. Verify the effectiveness of the corrective actions and conformance to the established procedures. Measure the areas of progress and communicate the results. Escort and/or host the FDA and Customer audits and/or visits. Audit suppliers as per annual audit schedule. Support Recall and/or Product Removal activities Communicate new regulations, standards and industry practices to the organization. Support training program in relation to cGMP/ISO requirements. Review and approve Procedures Document Change Control to the existing procedures and new ones on as needed basis.

Qualified candidates for this position will possess: 3-5 years' compliance/quality experience Bachelor's degree (4 years) in Science or Engineering Pharmaceutical industry exp. required ASQ certification preferred Experience and solid understanding of: o 21 CFR 203, Prescription Drug Marketing o 21 CFR 210 & 211, Good Manufacturing Practices o 21 CFR 314, Field Alerts o Food Drug and Cosmetics Act o 7346.832 Pre-Approval Inspections/Investigations o FDA guidelines, policies & procedures impacting Leiner Health Products. Knowledge of auditing procedures, practices, and requirements Able to comprehend and interpret quality regulations, guidelines, and standards. Standard computer skills (Windows and Microsoft applications such as Word, Excel, Access) Planning of audits and making effective use of resources during the audit Organize and direct the audit/audit team, including: o Provide direction and guidance to auditors-in-training o Ability to utilize factual observation to reach audit conclusions o Prevent and resolve conflicts effectively Understanding of the quality management systems, tools and their application Ability to read, write, speak English fluently Ability to use scientific knowledge to make sound judgment based on factual evidence Ability to plan, organize, and prioritize tasks effectively Ability to effectively interact with External auditors and Regulatory Agency representatives at all levels of the hierarchy Ability to develop or review responses to address regulatory agency findings.

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