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Job Opening - Quality Auditor
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Basic Function and Responsibility:
This position is responsible for performing internal and external audits for G&W’s QA Compliance group. Audits will include GMP audits (internal/external), due diligence audits. The scope of the internal audits will consist of all Quality systems (e.g., Quality, Laboratory, Production, etc.). The External audit scope will consist of excipient/API/component suppliers, contract laboratories, and contract manufacturers.
Work Performed:
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Schedule, perform, document, make observations, write reports, and follow-up on audits of domestic and foreign suppliers of active pharmaceutical ingredients, excipient raw materials, packaging components, contract laboratories, and contract manufacturing service providers that are being used or considered for use as manufacturers or packagers of drug product.
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Schedule, perform, document, make observations, write reports, and follow-up on audits of internal Quality Systems.
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Maintain quality records of all audits.
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Generate metrics/trending charts from audits performed.
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Aspects of Performance:
Maintains confidentiality.
Possesses sound analytical problem-solving and documentation skills.
Demonstrates ability to prioritize.
conflicting demands.
Executes assigned tasks within established.
schedule.
Writes and speaks clearly and concisely.
Develops and maintains expertise through continuing professional education and training.
Complies with Company policies, procedures, rules and regulations.
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Qualifications:
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Experience (both internal and external) auditing manufacturing facilities, equipment, laboratories and service providers
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A working knowledge of pharmaceutical manufacturing processes.
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A working knowledge of pharmaceutical testing laboratory procedures and instruments.
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A working knowledge of the current Good Manufacturing Practices and the ability to apply that knowledge to assure that providers of materials and services are compliant.
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Excellent verbal and written and organizational skills. The position requires that the employee communicate with internal and external management groups in order to assure that non-compliant conditions noted during audits are addressed.
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Ability to get Visa required for travel to foreign audit sites
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Ability to perform audits in industrial or laboratory settings.
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Ability to travel for up to two weeks at a time both foreign or domestically (travel is approximately 15% of time
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Strong computer skills, Microsoft Office Applications (Access, Excel and Word).
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Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress to Management.
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Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities.
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Must be able to work a consistent schedule to satisfy the responsibilities of the job.
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Knowledge of electronic document systems.
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A minimum of five years in regulatory compliance, quality assurance or quality control laboratory experience in the pharmaceutical industry.
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Education:
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A Bachelor’s Degree in a scientific discipline.
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