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Spécialiste AQ, Investigation

3 months ago

Montreal, Quebec, Canada Pharmascience Full time

The QA Investigation Specialist is responsible for writing, reviewing and coordinating investigations, non-conformance reports and deviations occurring in PMS plants. He evaluates risks and impacts on patients, systems and product quality. He issues CAPAs to prevent occurrence and/or recurrence and contributes to the trends analysis report generation.

Tasks and responsabilities:

Coordinates raw material, manufacturing and packaging lot, utility, OOS lab results, or general GMP non-compliance investigations : Information gathering Root cause investigation Patient, product and systems risk evaluation Corrective and preventive actions recommandation Completes investigations tasks related to complaints management system Performs or validates Initial Reviews of deviations. Approves and closes notes to file and minor deviations Execute required transactions in electronic systems (SAP) Maintains investigation databases Attends investigation meetings as the QA expert Contributes to periodic trend analysis reports generation. Contributes to the periodic report of performance indicator reports generation and to issues recommendations as required Keep up to date deviations management procedures.

Skills, knowledge and abilities :

Strong analytical skills and ability to summarize vast amounts of data Technical writing skills Problem-solving skills Planning and organizational skills Values collaboration and team spirit Facility to interact and excellent aptitude to communicate with people Green Belt Lean Six Sigma Certification would be an asset Fluent in English & French (oral & written) Competent with MS Office, SAP would be an asset Excellent knowledge of laboratory and pharmaceutical manufacturing operations