About the Job
The Quality Analyst Audits is responsible for assisting in all customer inspections. Incumbent will assist in coordinating and conducting audits and inspections to ensure regulatory quality compliance by performing the following duties. Arranges and manages the internal audit schedules and conducts audits of internal departments to assure compliance with Patheon Corporate Standards, SOPs, and Regulatory Requirements. Follow-up audits of internal operations and applicable contract service providers, such as manufacturing sites, analytical laboratories, and raw material vendors
Assists in customer audits and Regulatory Inspections including scheduling, hosting and audit response. Maintain internal and external audit schedules. Ensure completion of audits are tracked and performed on time. Conducts internal audits per the schedule, writes reports, and follows up on all CAPA activities. Responsible to initiate and maintain GMP questionnaires and score cards with vendors. Coordinate with quality, procurement, operations, and R&D globally to identify an audit schedule. Initiate employee training on auditing practices. Interpret FDA regulations and comparable international regulations, SOPs, and other company policies and procedures on regulatory compliance. Maintain detailed understanding of current regulatory requirements. Perform and document external audits of suppliers, vendors, contract manufacturers, contract laboratories, and contract service providers to identify deficiencies and non-conformances, assess and report the level of compliance to regulatory and quality requirements, and assure implementation of appropriate corrective and preventive actions. Audit activities include initiation and execution of the audit, generation of the final report and recommended corrective actions, review of corrective action plans and closure of follow-up activities. Performs other reasonable, related business duties.
BA/BS in a technical discipline and
At least 2 years experience in a GMP Pharmaceutical Manufacturing, Quality Assurance and or Product Development industry.
Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies: Knowledge of Good Manufacturing Practices, EU Good Manufacturing Practices and FDA and the ability to recognize non compliance with these regulations. Strong analytical ability. Has good written and oral communication skills. Strong proficiency in Microsoft Office Suite -Word, Excel, and PowerPoint.