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Qa emu specialist – engineering, maintenance & utilities

Green Cross Biotherapeutics Inc.

This is a Full-time position in Montreal, QC posted November 3, 2019.

Position Summary The Quality Assurance Engineering Maintenance & Utilities (EMU) Specialist is responsible for the delivery of quality assurance activities at the Green Cross Biotherapeutics (GCBT) site, specializing in engineering, maintenance and clean utilities areas.

The QA EMU Specialist position ensures that engineering, maintenance and utilities operations are conducted in accord accordance with cGMP, Corporate and Regulatory requirements.

This responsibility requires the delivery of QA and compliance support in the EMU areas for the site.

The Quality Assurance EMU Specialist executes the site QA activities at GCBT in order to protect the safety, quality and efficacy of our products, through the compliant operation of clean utilities systems and the effective support of calibration, maintenance, engineering projects and systems.

This key role must ensure effective interaction with other engineering, operations, maintenance and utility departments.

The QA EMU Specialist ensures that all quality system records (e.g.

deviations, CAPAs, change controls, etc), are supported with GMP document review, and effective quality oversight.

In particular, this will involve partnering with major stakeholders such as Operations, QC, and Facilities to optimize quality systems and related processes for engineering, maintenance and utility support functions.

Key Duties and Responsibilities Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to GCBT engineering, maintenance and utility system operations.

Acts as quality point person, providing guidance and feedback on quality assurance issues.

Provide key decisions as needed for the engineering, maintenance and utility system operations departments.

Performs timely review of documentation/investigations/reports specific to engineering, maintenance and utility system operations, highlighting and assisting in the resolution of issues commensurate with the level of risk Provide sound QA and Compliance support to engineering, utilities, maintenance, calibration and all related EMU systems in order to ensure operations are functioning in a state of compliance for the production of commercial products.

Ensure relevant QA documents and procedures are approved to schedule to support ongoing operations of all facility systems (maintenance, calibration, clean utility operations).

Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives as the key Quality point of contact supporting EMU departments.

Deliver Quality Assurance review and approval of SOPs, quality records, policies, operational standards, validation protocols and reports as required to certify compliance with specifications and procedures, supporting EMU departments.

Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending, supporting EMU departments.

Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness, supporting EMU departments.

Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems, supporting EMU departments Representing Quality Assurance to guide various project and technical meetings, as needed, supporting EMU departments.

Working with EMU departments to guide timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions Inputting information from the Quality Systems into electronic databases and generating reports from these systems to provide related reports on the quality management system for engineering, maintenance and utility departments.

Capturing and reporting metrics around Quality System for engineering, maintenance and utility departments.

and closure/approval times.

Providing on the floor support to facilities for the operation of clean utilities, clean rooms and related facility systems.

Document creation and review, including Standard Operating Procedures, study protocols, and reports Provide training to site personnel and contractors on GMP and the Quality System procedures specific to the facility, utility, calibration and maintenance systems.

Actively contributes to continuous improvement activities.

Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.

Ensure GCBT activities comply to the applicable current GMP regulations and GCBT SOPs Ensures the integrity and traceability of all data generated and reported Performs other duties as assigned by Quality Lead Qualifications: University Degree in Chemical Engineering, Mechanical Engineering, Biology, Biochemistry, Chemistry, Microbiology or related discipline.

Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, EMA or other regulatory authorities.

6 to 10 years relevant experience within the biotech, pharma industry or a related field, with direct experience in pharmaceutical engineering systems, maintenance, calibration systems and clean utility operations.

Experience in biologics/parenteral products/sterile manufacturing preferred.

Strong knowledge of Health Canada and US FDA cGMP requirements for pharmaceutical manufacturing and pharma/biologic facility operations required.

Excellent accuracy and attention to detail Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.

High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.

Technical writing skills required.

Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

The individual in this position is expected to represent GCBT interests, objectives and policies in a responsible and professional manner.