Specialist, Quality Assurance Systems

Scientific Search; Montreal; On-site; CAD 60,000 - 85,000; Full time

Job summary

A global pharmaceutical CMO is seeking a Quality Assurance professional in Montreal. The role involves coordinating quality-based systems and ensuring compliance with GMP regulations while providing technical support and guidance. Successful candidates will have a BSc in a relevant field and at least five years of QA experience in the pharmaceutical sector.

Qualifications

• Minimum five years experience in Quality Assurance/control or regulatory compliance in pharmaceuticals.
• Knowledge with compendia (USP, EP, BP) and cGMP regulations.
• General knowledge of Quality systems, Operations and Quality control processes.

Responsibilities

• Coordinates and supports quality-based systems to optimize company processes.
• Ensures technical content and compliance to GMP regulations.
• Leads quality-based initiatives to optimize operations and programs.

Skills

Bilingual (French & English)

Report writing

Technical support

Data entry

Knowledge of cGMP regulations

Education

BSc in chemistry, microbiology or closely related discipline

Tools

Microsoft Office

TrackWise

MasterControl

SAP

Job description

Onsite in Montreal, QC

Company Profile: Global Pharmaceutical CMO

What You Will Be Doing

Coordinates and supports quality-based systems to optimize company processes and ensures appropriate technical content and compliance to GMP regulations, company standards and customers’ requirements.

• Annual product review: (APR) Gathers and compiles data and provides to customers as per established timeline.
• Ensures integrity and traceability of all data generated and reported. Notifies immediately Manager of any out-of-specification, out-of-trend, incomplete information and other irregularities.
• Leads quality-based initiatives at both documentation and process level in order to optimize operations and programs. Ensures ongoing improvement of established procedures and adherence to new systems/processes and compliance with regulatory requirements.
• Performs additional duties assigned by Management.
• Change control management: Coordinates change controls to determine impacts on products and/or processes.
• Leads quality-based initiatives at both documentation and process level in order to optimize operations and programs. Ensures ongoing improvement of established procedures and adherence to new systems/processes and compliance with regulatory requirements.
• Performs additional duties as assigned by the Manager, Quality Systems Department.
• Performs any other tasks assigned by Management.
• Evaluate and approve change controls related to SOP’s.
• Format and issue SOP’s.
• Load documents in SAP for approval purposes (SOP’s)
• Distribute controlled copies of SOP’s and ensure that all obsolete copies are destroyed.
• Maintains database of controlled paper copies of SOP’s
• Notification and follow-up for SOP review
• Master documentation control of SOPs such as issuing or cancelling documents according to tasks in notifications.
• Issue production batch records for manufacturing, packaging and inspection.
• Print production batch records for manufacturing, packaging and inspection.
• Print Stability labels according to SOP if required
• Print Sampling Plan and corresponding labels according to instructions.
• Verification and Confirmation of the PI Sheet in SAP
• Print identification labels for production if applicable
• Prepares, reviews and maintains specifications for finished products, raw materials and packaging components in SAP ensuring technical accuracy and compliance to customers’ requirements, GMP, and compendia standards, and adherence to established timelines.
• Issues and maintains analytical methods, and/or analytical work orders.
• Provides technical support and guidance relative to the TSE/BSE and other regulatory contaminants requirements
• Translates applicable regulatory requirements as well as customers’ requirements into technical documentation and ensures internal communication of these to appropriate departments
• Performs additional duties assigned by Management.
  
  

Key Interfaces

• Clients
• Operations, Quality, Production, Commercial, Validation, Technical Services, Supply Chain
  
  

What you will bring to the table:

• BSc in chemistry, microbiology or closely related discipline.
• Minimum five (5) year experience working in Quality Assurance/control or regulatory compliance within pharmaceutical or healthcare industry.
• Knowledge with compendia (USP, EP, and BP) and cGMP regulations.
• General knowledge of Quality systems, Operations and Quality control processes.
• Proficiency in computer and data entry (Microsoft Office, TrackWise, MasterControl and SAP environment).
• Bilingual (French & English). Proficiency in English is essential.
• Solid report writing ability.
  
  

If you would like to learn more about this great opportunity, please reach out to Brittany Moore at [e-mail]