Spécialiste des systèmes de qualité/Quality Systems Specialist

Objet et champ d'application:

Le spécialiste de la qualité est chargé de représenter les initiatives en matière de qualité et les objectifs de conformité des sites dans le cadre de l'élaboration des méthodes, des procédures, des validations et de la planification de la qualité de l'établissement. Ce poste apportera son soutien à tous les produits existants ainsi qu'à la conception de nouveaux produits.

Responsabilités:

Participer à l’élaboration, à la révision et à l’amélioration du plan de qualité de l’usine et des processus de fabrication.

Utiliser des méthodes statistiques appropriées, telles que l’analyse des tendances, pour faciliter l’analyse ou l’examen des données de fabrication, de qualité et/ou de laboratoire afin de détecter des problèmes récurrents ou des tendances négatives. Lorsque des problèmes récurrents et/ou des tendances négatives sont identifiés, recommander des mesures correctives pour résoudre les problèmes.

Aider, selon les instructions reçues, les équipes chargées des systèmes de qualité et des opérations de production à se conformer aux exigences de Santé Canada et de la FDA.

Education:

• Diplôme de baccalauréat en génie, en sciences, en chimie ou en biologie (préférable) OU diplôme du programme de techniques de laboratoire.

Expérience et compétences requises:

Au moins 1 an d’expérience combinée en ingénierie de la qualité et en validation des procédés est requis. Une expérience dans la fabrication de produits pharmaceutiques, de dispositifs médicaux et/ou en laboratoire (chimie organique, analyse et/ou microbiologie) est préférable.

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Purpose and Scope:

The Quality Specialist is responsible for representing the sites’ quality initiatives and compliance objectives in the development of methods, procedures, validations and quality planning of the facility. This position will support all existing products as well as new product design.

Responsibilities:

• Participate in development, review and improvement of the facility’s Quality Plan and manufacturing processes.

• Performs plant investigations into product complaints and prepares reports for review by Quality Manager prior to submittal to Corporate Quality Systems.

• Analyze processes, work operations, quality records, complaints and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigate and assist in making recommendations necessary to correct and prevent recurrence (NC).

• Use appropriate statistical methodology, such as trend analysis, to assist in analyzing or reviewing manufacturing, quality and/or laboratory data for recurring problems of the detection of negative trend. When recurring problems and/or negative trends are identified, recommends corrective action for problem resolution.

• Draft, review and/or assist in the implementation of validation protocols, final validation reports, quality system procedures, installation, operational and performance qualifications, analytical test method and Documentation Change Requests.

• Perform CpK and trend analysis for manufacturing systems, establishes reports and procedures in conjunction with Plant Operations to assure system reliability and product quality.

• Reviews processing procedures in new and existing programs to assure enhanced quality while remaining in compliance with Health Canada, FDA and cGMP.

• Participates in management of the plant metrology programs to assure all appropriate tooling is available for inspection and test and that all calibration activities are performed when due.

• Participates in the excursions investigations and in the elaboration of corrective and preventive actions (CAPA).

• Assist, as assigned, the Quality Systems and Production operations with compliance to Health Canada and FDA requirements.

• Participate as a member of the facility’s Audit Team in performing internal and external audits as required.

• Assist in providing in-house training (e.g. calibration, validations) in conjunction with plant management; to operators and other personnel, as assigned.

• Participate in product design control activities for new product lines.

• Conduct risk analysis as part of design control for new and existing product lines to identify potential hazards associated with the device design under both normal and fault conditions.

• Perform monitoring of Quality data (Monthly trending and annual product quality review).

• Perform laboratory and environmental investigations.

• Support laboratory analyses as needed.

• Designee for Quality Systems Manager functions and or responsibilities including product release.

• Other duties as assigned by the Quality System Manager.

• Create POs or process invoices as needed using SAP.

Education:

• Bachelor degree in Engineering, Science, Chemistry or Biology preferred OR Diploma in Laboratory Techniques program

Experience and Required Skills:

• Minimum of 1 year of combined Quality Engineering, process validation required. Pharmaceutical manufacturing, medical device manufacturing and/or laboratory (organic chemistry, analytical and/or microbiology) experience preferred.

• Bilingual (FR/EN) is an asset.

• Knowledge of process validation (IQ, OQ, PQ, ATMV), analytical instrumentation, Health Canada and FDA regulatory requirements, statistical process control and statistical problem solving.

• Must have good organizational skills and be able to perform work with little supervision. Position requires a mathematical aptitude with a good background in algebraic skills and statistical analysis skills.

• Knowledge of analytical laboratory methodologies is important.

• Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.

• Good knowledge of Microsoft Office applications (Word, Excel, PowerPoint).