Bilingual (french English) Quality Assurance Supervisor
Boisbriand, QC, Canada
Job Description
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Job Position:
- Bilingual ( French - English) Quality Assurance Supervisor
- Manage review and approval of analytical test data generated. Perform deviation investigations and CAPA implementation of issues involving testing conducted by external as well as internal Quality control testing lab. Design and implement appropriate corrective actions as needed in a timely manner.
- Document the overall review of methods and implement corrective measures. Proposes requalification or revalidation of methods for improvement of quality operations.
- Review quality control testing of Raw Material, In-process, Finished Product, stability study samples
- Manage equipment calibration and qualification program for the laboratory equipment
- Participate in the selection, configuration and qualification (i.e. IQ/QQ/PQ) of laboratory equipment and developing operational procedure for calibration and operation of laboratory equipment
- Review and approve certificate of analysis (COA), Product specification, Safety data sheets and QC test reports for quality file records and for submission to the clients.
- Manage Technical/Quality Agreements with third-party service providers relevant to the Davion Canada Site
- Collaborate with R&D and QC team to set specifications for Cosmetic, medical device and Drug Product. Manage review and approve changes to methods, processes, and product specifications.
- Lead or participate in Quality and Compliance initiatives. Assist during inspections/audits (regulatory or internal) and audit observation responses
- Ensure compliance of standard GMP practices as per Health Canada and US FDA regulations.
- Ensure compliance of standard Good Pharmacovigilance practices (GVP) as per Health Canada
- Conduct Customer complaint investigation and identify Adverse Drug Reaction events. Assist General manager/ designated ADR coordinator with follow up and investigation of ADR reports
- Assist General Manager with documentation and communication related to reporting for ADR to Health Canada. Maintain and manage the documentation records related to GMP and GVP guidelines and requirements
- Efficiency of the quality department
- Compliance with GMP and GVP
- Good resource management
- Accuracy of records
- Minimum of 2 years of relevant discipline experience directly supporting Quality operations experience
- Bachelor\xe2\x80\x99s degree in engineering/applied science/Chemistry
- High attention to detail and accuracy
- Strong analytical skills with a systematic approach to problem-solving and issue resolution combined with solid understanding of the relevant technologies and design and their practical applications.
- Ability to interpret and evaluate complex processes, develop, and propose risk-based options to resolve issues and implement solutions.
- Able to confront and resolve conflict and lead efforts resolve critical situations.
- Knowledge of regulations and standards affecting pharmaceutical, NHP and Cosmetic products.
- Ability to understand impact of defects in on-market products and applies decision-making consistent with company and regulatory quality Policy.
- Knowledge of regulations and standards affecting pharmaceutical, NHP and cosmetic products
- Advanced knowledge of standards and applicable Health Canada regulations for GMP and GVP required.
- Advanced technical understanding of Quality Systems/Policies/Procedures and pharmaceutical, NHP and Cosmetic Products.
- Must be able to establish strategic direction and lead change. Advanced written and oral communication skills Able to manage multiple tasks and priorities
- Expertise with Quality System Regulations Strong problem-solving skills
- Medical and Dental Insurance after 3 months
- Parking Provided
- Salary offered: $52.000.00
- Number of hours per week: 40 hours
- Job status: permanent - 8:00 am to 4:30 pm
- Dental care
- Extended health care
- Life insurance
- On-site parking
- 8 hour shift
- Monday to Friday
- Boisbriand, QC: reliably commute or plan to relocate before starting work (required)
- Bachelor\'s Degree (required)
- quality assurance: 2 years (required)
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Job Detail
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Job IdJD2137518
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBoisbriand, QC, Canada
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EducationNot mentioned