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Working at MedXL
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When enhancing lives is your quest, your work is meaningful, your contributions significant, and your curiosity is driven by limitless possibilities, that’s MedXL. Here your compassion, commitment and delivery of results will take us far. Together, we can make a difference in healthcare around the world.
MedXL is committed to employment equity
MedXL is committed to employment equity and encourages applications from women, members of visible minorities and persons with disabilities. As an equal opportunity employer, we are committed to fair employment practices to ensure that qualified candidates have access to employment opportunities and that hiring decisions are made on the basis of merit.
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Available Positions
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March 6, 2023Details
Quality Assurance SpecialistJob summary
Must be able to apply Canadian, American and European GMP regulations. Support Quality Assurance & Compliance Manager to ensure compliance of the batch record verification process in accordance with Good Manufacturing Practices (GMP), company standards, product specifications and procedures.
Main responsibilities :
- Performs the revision of production documents in accordance with internal procedures and GMP’s.
- Ensure the continuous flow of processes associated with the manufacture and/or packaging of finished products and the intermediate stages.
- Issues certificates of compliance and required documentation upon release of finished products.
- Coordinate all activities related to the batch review process and participate in the implementation and maintenance of the department’s performance tools.
- Identifies and evaluates related documents such as, but not limited to, nonconformance reports, Change controls, Validation documents, etc., to ensure product quality.
- Coordinate batch disposal/release activities from the computer system.
- Ensure that the batch revision and release cycle time is respected in order to minimize product stock-out situations.
- Be able to identify, when reviewing documents, the need for an investigation if a compliance issue is identified during the manufacturing and/or packaging process.
- Collaborate with Operations, Logistics, Warehouse, Maintenance, Validation and Laboratory departments to proactively resolve potential compliance issues to deliver products on time.
- Perform the first review of non-conformance reports initiated.
- Actively participates and facilitates the timely completion of non-compliance reports.
- Actively participates in the completion and closure of CAPA’s and deviations.
- Minors and suggests immediate corrective action when production is directly impacted.
- Participate when required in special projects.
- Performs any other task to support the activities of the department.
- DEPENDING ON QUALIFICATIONS, may be required to perform the tasks of the biosafety officer on site (containment level 2 laboratory).
Organizational relationships:
Collaborates with the operations, logistics, warehouse, maintenance, validation and laboratory departments.Job requirements
EDUCATION: Possess a bachelor’s degree in science.
EXPERIENCE :. A minimum of 2 years of experience as a Quality Assurance Specialist in the pharmaceutical industry and knowledge of GMP’s.Skills/Qualifications:
- Very good knowledge of Good Manufacturing Practices (GMP).
- Work independently and demonstrate excellent team spirit.
Other:
- Knowledge of Microsoft Office (Word, Access, Excel)
- Be able to solve problems related to the manufacturing / packaging of products and have a logical thinking, meet deadlines and know how to deal with difficult / unforeseen situations, be reliable, enthusiastic and able to establish interpersonal relationships easily and have a developed sense of customer service.
- Spoken/written lagunages :
Excellent verbal and written communication is required, both in English and French.
Working environment:
- Office work. The candidate may be required to go on the floor (manufacturing/packaging plant) to understand and solve problems related to the manufacturing/packaging of products.
Deadline for CV’s : March 14, 2023
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March 6, 2023Details
Quality System SpecialistJob summary
Reporting to the Manager, Quality Assurance, the specialist is responsible for providing quality assurance support to the various departments of the plant.
Main responsibilities :
- Support the Change Control program.
- Monitor the implementation of Change Controls and ensure their effectiveness.
- Support data collection and drafting of APQPs and PMS.
- Support the internal audit program.
- Support the supplier management program.
- Support the document management program, including related administrative tasks and archiving.
- Support the administration of eGMSs.
- Provide support for manufacturing investigations (complaints, non-conformities, CAPA, etc.), as needed.
- Coordinate special projects for the department (eQMS, ISO 13485, continuous improvement, etc.)
- Ensure GMP throughout plant processes.
- Depending on the qualifications, may be required to perform the tasks of the biosafety officer on the site (containment level 2 laboratory).
- Establish and maintain quality standards aligned with applicable international cGMP regulations and guidelines and ISO standards.
- The list of tasks and responsibilities mentioned above is not restrictive. In the performance of your duties, the Quality Assurance Specialist performs any task related to your job for the proper functioning of the organization.
- DEPENDING ON QUALIFICATIONS, may be required to perform the tasks of the biosafety officer on site (containment level 2 laboratory).
Organizational relationships:
Collaborates with the operations, logistics, warehouse, maintenance, validation and laboratory departments.
Job requirements
EDUCATION: BAC in science or any related discipline.
EXPERIENCE :.
A minimum of 5 years of experience in a pharmaceutical industry.Knowledge of GMPs and their applications in a sterile product environment.
Skills/Qualifications:
- Knowledge of Microsoft Office (Word, Access, Excel).
- Very good knowledge of Good Manufacturing Practices (GMP).
- Demonstrated interpersonal skills.
- Work independently and demonstrate excellent team spirit.
- Collaborate successfully with various departments.
- Experience in microbiology would be an asset.
- Must be available to support a plant that operates 24/7.
Other:
- Spoken/written lagunages :
Excellent verbal and written communication is required, both in English and French.
Deadline for CV’s : March 14, 2023
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February 20, 2023Details
Technician, Chemistry III LaboratoryJob summary
The candidate will be responsible for performing chemical analyzes related to all stages of the manufacture of sterile and non-sterile pharmaceutical products, in accordance with established procedures and GMPs.
Main responsibilities :
- Perform physico-chemical tests on water, raw materials, products in process and finished products using established methods as well as the various pharmacopoeias (USP, EP, BP, JP).
- Perform calibration, calibration and checks on various laboratory instruments.
- Participates in different types of investigations such as OOS, CAPA, exception report.
- Support production lines as needed.
- Participates in procedural reviews and the writing of analysis reports.
- Respect the schedule and deadlines in accordance with manufacturing.
- Occasional involvement in certain special projects or studies such as Kaizen, Lean Manufacturing, 5S, etc.
Job Requirements:
EDUCATION: College or university degree in science.
EXPERIENCE: 3 to 5 years of experience in quality control, Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
SKILLS/QUALIFICATIONS.
- Knowledge of pharmacopoeias, instrumentation (basic laboratory equipment, HPLC, UV/IR spectrophotometer, etc.), computer software.
- Ability to work effectively within a team.
- Experience in the pharmaceutical, cosmetic or food industry would be an asset.
- Knowledge of Microsoft Office software (Word.Excel).
- Excellent interpersonal and communication skills.
- Excellent priority management skills and ability to work under minimal supervision and tight schedule.
OTHERS: Bilingual
WORKING ENVIRONMENT:
- Day or evening shift ( 40 hrs per week)
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July 19, 2022Details
Prefilled Syringe Technician - Night shiftMEDXL INC.
POSITION DESCRIPTION
TITLE : Technician
DEPARTEMENT : Manufacturing
SERVICE : Prefilled Syringes
SHIFT: Night
10:40PM to 6:40AM, Sunday to Friday
37,5 hours paid per week
SUPERVISOR TITLE : Team Leader
TASKS AND RESPONSIBILITIES
· Check the work on the billboard.
· Check the tickets on the approved products.
· Supply the machine with tickets.
· Carry out the filling of syringes by machine (hopper) and by hand.
· Put aside syringes at the beginning, the middle, and the end to be sampled by quality control.
· Check the tickets applied on the syringes and count the rejects.
· Fill the syringes on the pump.
· Check the syringes (for dirt, level of liquid).
· Put the caps on syringes and then put them in the bin.
· Take the bins when filled with syringes and put the bin at the proper place.
· Make sure of the availability of the raw material and the supplies.
· Pack the syringes with the appropriate equipment.
· Check the lot, and the printing on the ticket.
· Place product in box, tape the top and put the sticker on the box.
· Count the boxes.
· In some case pack the product manually for certain products.
· Operate various machines.
· Respect the company policies.
· Carry out maintenance of the equipment and your working area.
· Apply the regulations of health and security at work.
· Apply the regulations regarding contamination in the company.
· Perform all related tasks.
NECESSARY QUALIFICATIONS
· Having a secondary 5 minimal.
· No experience required.
REQUIREMENTS
· Impeccable personal hygiene.
· Diligence, adaptability, punctuality, meticulous and responsible.
· Good manual dexterity and good organizational skills at work.
· Capable of working with a team.
· Reach a good execution speed.
PROBATION PERIOD
· 3 months
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April 21, 2022Details
Coordonnateur(trice) AQTÂCHES ET RESPONSABILITÉS
· Responsable du suivi des requêtes de changements et des non-conformités.
· Rédiger et réviser les procédures d’assurance qualité et contrôle qualité.
· Responsable de la formation du nouveau personnel du département sur les systèmes qualité implantés.
· Responsable de la gestion documentaire du système qualité afin qu’elle soit conforme aux normes et règlements.
· Participer à la qualification et la sélection des fournisseurs en collaboration avec l’ingénierie et les achats.
· Gérer les plaintes des fournisseurs et des clients.
· Faire le suivi des CAPA.
· Participer aux dossiers de validation de processus.
· Participer à la rédaction des procédures d’opérations normalisées (PON).
· Vérifier le dossier de fabrication pour le relâche des lots de fabrication et émettre le certificat de conformité.
· Participer aux audits internes et externes.
· Faire le suivi d’audit de la dose de stérilité.
· Participer aux réunions du département.
· Faire le suivi de la stabilité permanente.
· Effectuer les KPI
· Effectuer la surveillance post-commercialisation.
· Soutien de Contrôle de qualité dans le cas de besoin.
· Effectuer toutes autres tâches connexes.
QUALIFICATIONS REQUISES
· Posséder un B.Sc et avoir une expérience minimale de 2 ans comme coordonnateur en assurance qualité
· Avoir de bonnes connaissances des logiciels de bureau courants.
· Maîtriser les bonnes pratiques de fabrication.
· Être bilingue à l’écrit.
· Maitrise les normes 13485 :2016, CMDR, CFR21PART820, MDD 93/42/EEC,
EXIGENCES
· Être adaptable, assidu, résistant au stress, minutieux.
· Être capable d’apprendre et de travailler en équipe.
· Avoir de bonnes capacités de travail et d’analyse, de l’initiative, du jugement, une bonne organisation de travail.
PÉRIODE D’ESSAI
· 6 mois.