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Jubilant DraxImage inc.: Manager, Quality Assurance

Jubilant DraxImage inc.

This is a Full-time position in Montreal, QC posted June 6, 2021.

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Manager, Quality Assurance position to join our growing team What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc.

is a rapidly growing company with offices in Kirkland, QC and Yardley, PA.

A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team.

Jubilant DraxImage is a proud member of the Jubilant Pharma family.

For more information, visit www.Draximage.Com We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce.

Our goal is to have a workforce as diverse as the patients and clients we serve.

We have an inclusive environment where our employees can thrive and where our differences are welcomed.

By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary Responsible for batch release, ensures that all products which are manufactured and tested meet the internal standards of JDM and those of the required regulatory authorities ((HPFBI, FDA, EU, CMDCAS, ISO13485 etc.).

Lead activities in multiple quality systems such as SOP, MBR approval and Annual Product reviews.

Provides Quality oversight of production activities.

Responsabilities Oversees all activities associated with API, raw material, semi and finished product and device releases, the review of all related documentation to ensure conformance to GMPs/medical device requirements and regulations Oversees activities associated with JDI training program, including the review and approval of all related documentation to ensure conformance to GMP and regulations.

Manages review and approval of GMP documents related to Quality Systems such as but not limited to Master Batch Records, SOPs, validation documents, stability reports, product specifications, APQRs, etc.

Provides Quality Assurance presence on the production floor to ensure quality oversight of production activities.

Ensures those programs and relevant documentation are maintained in compliance with all applicable regulatory standards and guidelines.

Prioritize team efforts in order to maximize corporate objectives and coordinate the tasks of the team in order to fulfill the department objectives.

Recruits and trains staff to carry out all functions of the Quality Assurance.

Periodically reviews the performance of employees with regards to the achievement of goals, objectives and key performance indicators.

Coach the team and ensure professional development of employees and knowledge redundancy among the Quality team.

Build and maintain successful cross-functional relationships with internal departments (QC, Production, Validation, R& D, etc.) as well as clients and external suppliers.

Ensures quality project schedules are maintained and communicated to both internal and external management.

Trends key performance indicators and conducts appropriate follow-ups as required.

Provides periodic status to Management as requested.

Brings to the attention of the Director, Quality Operations and Site Management Committee, information relating to the impact of legislation on the functions of the site.

Informs immediately of all potential recalls and / or critical issues.

Performs additional duties as assigned by Management.

Minimum B.Sc.

– specialization in Chemistry, Microbiology, or closely related discipline Ten (10) to fifteen (15) years of experience in Quality Assurance / Control and Compliance within the pharmaceutical or healthcare industry, with at least five (5) years in a management role.

Broad experience with regulatory, ISO13485 and GMP standards associated with process control and validation, manufacturing and packaging, testing.

Experience in dealing with regulatory authorities Microsoft Office Knowledge of ERP system (SAP) Knowledge of good documentation practices Excellent written and verbal communication skills Bilingualism (French & English).

Proficiency in English is essential