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First seen by our source: 5 hours ago

GMP Quality Consultant (Pharma)

@ RQC

Toronto, Ontario

Full-time
Apply now
SIGNALS

Overview

RQC is hiring a full-time GMP Quality Consultant to deliver quality assurance consulting to regulated pharmaceutical, medical device and natural health product clients. The role covers quality system lifecycle management, facility and computerised system validation, supplier audits and regulatory audit hosting, performed remotely or onsite. Candidates need knowledge of Health Canada and international GMP.

Responsibilities:

  • Lifecycle management of pharmaceutical quality systems
  • Qualification and validation of facilities, equipment and systems
  • Conducting supplier quality and GMP evidence audits
  • Hosting regulatory authority audits
  • Managing deviations, CAPA, change control and complaints

Requirements summary:

  • Post-secondary degree or diploma in quality assurance or regulatory affairs
  • Demonstrated experience with GMP, GLP, GDP and GCP
  • Knowledge of Health Canada and international GMP
  • Strong written and oral communication skills
  • Strong organization, time management and problem-solving skills
Source and dates

Source type not verified · apify-linkedin

Employer posting date
Not provided
First seen by our source
2026-11-14
Source record updated
2026-11-14

These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.

Job details

SeniorityMid level
DepartmentBusiness operations
Hours per week40 (estimated)
Work settingOffice, Client sites
PositionMostly sitting
Physical demandsphysical low · computer high
LanguagesEnglish
EducationCollege diploma (required), Bachelor’s degree (required)
Fields of studyQuality Assurance, Regulatory Affairs, Pharmaceutical Sciences, Life Sciences

Summary and details written by AI from the posting; the employer’s posting is the authority.

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Job description

The Quality Consultant is responsible for supplying establishment, validation, operational and other quality assurance consulting services to regulated industries, including those in the international Medicinal Product, drug, medical devices, and natural health products spaces.

Responsibilities include:

· Applying your scientific and regulated product knowledge to fulfill client projects, either remotely, or onsite

· Lifecycle management of pharmaceutical quality systems, including management of customer quality manuals and product documentation

· Qualification and validation of facilities, equipment and computerised systems

· Conducting supplier quality and GMP evidence audits

· Authoring and executing compliance approaches for site licensing or remediation.

· Hands-on application and management of quality tasks, at all stages of the drug manufacturing and supply lifecycle, with a focus on:

o Quality risk management

o Product quality system documentation

o Product disposition

o Equipment and process validation

o Electronic systems validation and governance

o Post-market product related activities (e.g., Stability and Annual product review, trending)

o Root cause investigation management

o Reporting and management review functions

o Corrective Action management

o Change management (including risk assessment)

o Analytical test validation and result review

o Quality document review and approval

o Regulatory authority audit hosting

o Product quality complaints

o Annual product quality review, trending and stability performance review

Skills and Job-Related Experience:

· Sound knowledge of quality assurance terminology, International and Health Canada Good Manufacturing Practices (GMPs)

· Demonstrated experience applying quality standards, including good manufacturing practices (GMP), good laboratory practices (GLP), good distribution practices (GDP) and as applicable good clinical practices (GCP)

· Awareness and experience in developing specified quality system components, such as a quality manual, site master file and validation master plan

· Communicate technical information effectively to peers, management, customers using language, graphics, and computer skills.

· Strong organizational and time management skills, combined with a proven ability to meet strict and established timelines.

· Strong problem-solving skills

· Strong written and oral interpersonal and communication skills

· Other language skills are an asset

· Capacity for pharmacovigilance activities an asset

· Knowledge in interpretation of regulations, labelling reviews, compiling regulatory eCTD submissions (drug identification number – DIN), drug establishment licence (DEL), new drug submission (NDS) is an asset

Educational Requirements:

· Post Secondary Quality Assurance and/or Regulatory required (University Degree and/or College Diploma/Certificate or equivalent experience).

· Areas of Specialization: Quality Assurance, regulatory affairs, cannabis, scientific/pharmaceutical industries

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