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Certara: 1977- Manager, Quality Assurance

Certara

This is a Full-time position in Montreal, QC posted July 19, 2021.

Certara is hiring a Quality Assurance Manager to support our Integrated Drug Development!

This position can be based out of our Montreal office location or can be full-time remote in Quebec or Ontario.At Certara, we accelerate medicines to patients by partnering with life science innovators.

Our Integrated And Proprietary End-to-end Platform With Biosimulation, Regulatory Science, And Market Access Solutions Combined With Our Strong Team Of Scientists And Subject Matter Experts Enable Our Clients To HaveIn the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services.informed decision-making & reduced clinical trial burdenhigher R& D productivityimproved patient outcomes & increased patient access to medicinesaccelerated regulatory approvalCertara is a global team that fosters and nurtures a diverse and inclusive culture.

We are proud to be an Equal Opportunity Employer.

The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.Job OverviewThis role will be responsible for the coordination of all Certara global quality assurance needs, ensuringcompliance internally, externally with customers/clients, and global regulatory agencies.Responsibilities Lead and Develop global quality assurance team that ensures Certara maintains the highest standards internally and externally, upholding global compliance requirements.

Work with key members of the executive staff to develop a project plan of implementing the required changes to quality assurance resources in support of a globalized department.

Oversee and perform Quality Assurance review/approval of software development methodology deliverable documents.

Oversee the maintenance records required for compliance with regulatory requirements and customer/client expectations.

Schedule, participate and perform internal audits of Certara Quality Management System, Client Deliverables and software-related areas ensuring that QA staff are assigned as appropriate.

Schedule and lead external audits of Certara vendors as required by SOP and risk score.

Draft new and maintain existing Certara Policies and SOPs along with assistance from Outside QA Consultants and Certara Business Leaders.

Manage facility and/or client project and software-specific audits by customers or their authorized representatives; assist with facility and/or software-specific inspections by regulatory authorities Manage the execution of computer system validation, computer system qualification, and computer equipment qualification projects Manage and assist with the investigation of deviations and documentation of deviations and corrective actions/preventive actions (CAPAs) Develop, manage, schedule and ensure that the QA team is providing training in areas such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), ICH Guidelines, 21 CFR Part 11, and Certara policies and SOPs to the Certara staff.

Schedule and also conduct client deliverable audits, and monitor critical phases of studies Review study reports, associated datasets and analyses, and associated documentation to ensure consistency of reporting and for compliance with Certara standard operating procedures (SOPs) and policies Review study reports, associated datasets and analyses, and associated documentation for compliance with regulations and guidelines (i.E., GCP and/or GLP), scientific practices, client SOPs and expectations Education, Experience, Training, And Knowledge Bachelor of Science (or equivalent) degree, scientific or health-related discipline preferred.

Management experience required.

Minimum 8-10 years of experience in US and/or International quality assurance, specifically in a regulated industry (preferably pharmaceuticals/biotechnology).

Minimum of 3-5 years executing computer system validation projects.

Minimum 3-5 years of experience as a Quality Assurance Representative/Quality Engineer/QA Tester for scientific or quality system software.

TrackWise Digital experience a plus Skills & Abilities Proficient in reading, writing, and communicating in English Knowledge and application of pharmaceutical regulations, guidelines, SOPs/policies, and protocols Familiarity with a variety of software tools (scientific, analysis, or quality system tools preferred) Knowledge of regulations, guidelines, SOPs/policies, protocols, document management processes Proficient in the use of Microsoft Office applications (i.E., SharePoint, Word, Excel, PowerPoint) Excellent written and verbal communication skills are required Organization and accuracy in documentation skills are required Ability to adhere to strict guidelines and procedures Ability to interact effectively in a team based environment Ability to work independently and work with limited direction Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance.

We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.Montreal Quebec-Ontario