Quality Assurance Specialist, Validation and

Help bring research to life and drive your career forward with the National Research Council of Canada (NRC), Canada’s largest research and technology organization.

The NRC is building a new permanent, GMP-compliant clinical trial material facility at its Royalmount Avenue site in Montréal. When complete, this facility will be used to manufacture vaccine and other biologic materials for clinical trials, to support vaccine development at the clinical trial stage.

As a member of the multidisciplinary project teams, the Specialist, Validation and compliance Quality Assurance actively participates:
1. New Facility and afterwards in routine: QA Validation

In all stages of the validation lifecycle for equipment, software, systems, and processes in compliance with applicable regulations, policies and procedures.

Some job responsibilities are related to new and existing clean utilities, equipment, software, systems, and processes (sterilisation, cleaning, QC method, manufacturing process and Viral inactivation and biological impurities removal):

- documents related to qualification and validation.
- deviation/non-conformance/change control/CAPA reports and records
- Change Control evaluations
- SOPs.
- Preventive maintenance and calibration plan and other activities related to Maintenance and calibration
- Risk assessments and impact assessments associated with Computerized system validation (CSV) activities and data integrity

2. In routine: QA Compliance

Some job responsibilities are:

- Management of Standard Operating Procedures (SOP’s)
- Conduct independent QA audit;
- Conduct vendor & subcontractor audit. Maintain the supplier quality management system;
- Support auditees in the preparation and during a regulatory agency or client audit;
- Manage batch records
- Release, reject or quarantine manufacturing lot, perform annual product quality review and other QMS trend analysis;
- CAPA, Deviation, Change Control, complaint, risk assessment review and approval

**Screening Criteria**:
**Education**:
Master’s Degree in IT, Chemistry, Biochemistry, Microbiology, Engineering (Chemical, mechanical) or other related discipline.

A Bachelor’s degree combined with relevant experience may be considered.

For information on certificates and diplomas issued abroad, please see Degree equivalency

**Experience**:

- Significant experience in biopharmaceutical / pharmaceutical / biotechnology sector in validation or in a similar role reviewing validation documents
- Basic experience in qualification of computerized equipment (bioreactors, Purification and filtration systems, including single-use equipment, etc.).
- Basic experience in quality assurance activities related commissioning, qualification and validation (CQV) requirements for equipment, utilities, facility
- Basic experience in quality assurance activities related to verification/ Validation : Cleaning, Sterilisation, process, QC method
- Significant experience in quality assurance/compliance activities such as: Standard Operating Procedures (SOP’s) lifecycle, Supplier quality management, Master batch record and executed batch record review and approval, batch release, CAPA, Deviation, Change Control, complaint, risk assessment approval

Note : Significant experience is minimum 5 years, whereas basic experience is 2 years.

**Condition of Employment**:
Reliability Status

**Language Requirements**:
Bilingual Imperative BBB/BBB

Information on language requirements and self-assessment tests

**Assessment Criteria**:
**Technical Competencies**:

- Strong multi-faceted technical background and understanding of validation frameworks across all operations functions: commissioning, qualification and validation (CQV) requirements for equipment, utilities, facility and processes.
- Understanding of CSV requirements.
- Strong Understanding of quality assurance and compliance requirements related to: Standard Operating Procedures (SOP’s) lifecycle, Supplier quality management, Master batch record and batch record review and approval, batch release, CAPA, Deviation, Change Control, complaint, risk assessment approval.
- Strong knowledge of GMP, 21 CFR Parts 820, 210/211, ISO and GAMP standards, PIC/S Guidelines, WHO Guidelines related to Computerized System Validation (CSV) and Data Integrity, Health Canada GUI-0001 and GUI-0036, ICH guideline for biologics, Eudralex.
- Strong accuracy and attention to detail.
- Excellent interpersonal skills, communication and organizational skills.
- Strong judgment, decision making and trouble shooting skills.

**Behavioural Competencies**:

- Management services - Communication (Level 3)
- Management services - Conceptual and analytical ability (Level 3)
- Management services - Teamwork (Level 2)
- Management services - Initiative (Level 2)
- Management services - Results orientation (Level 2)

**Competency Profile(s)**:
**Relocation**:
Relocation assistance will be determined in accordance with the NRC's directive