GMP Quality Consultant (Pharma)

RQC; Toronto; Hybrid; CAD 83,000 - 179,000; Full time

Job summary

The Quality Consultant at RQC provides established QA consulting services to regulated industries, including pharmaceutical, medical device, and natural health product spaces—working remotely or onsite.

You will manage lifecycle quality systems, qualification and validation activities, supplier quality audits, and develop compliance approaches for site licensing or remediation, with emphasis on GMP, GLP, GDP, and GCP practices.

Qualifications

• Post secondary QA and/or regulatory degree or equivalent experience.
• Experience with GMP, GLP, GDP and possibly GCP.
• Ability to interpret regulations and compile regulatory submissions.

Responsibilities

• Provide QA consulting remotely or onsite.
• Manage quality systems documentation lifecycle.
• Qualify and validate facilities, equipment, and computerized systems.
• Perform supplier quality and GMP audits.
• Develop compliance strategies for licensing or remediation.
• Oversee quality activities across drug lifecycle, including review and regulatory audits.

Skills

Quality assurance

GMP

GLP

GDP

GCP

Regulatory affairs

Communication

Time management

Problem solving

Pharmacovigilance

Regulatory submissions knowledge

Education

University degree or college diploma in QA/regulatory

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:
  • Quality risk management
  • Equipment and process validation
  • Electronic systems validation and governance
  • Post-market product related activities (e.g., Stability and Annual product review, trending)
  • Reporting and management review functions
  • Corrective Action management
  • Analytical test validation and result review
  • Quality document review and approval
  • Regulatory authority audit hosting
  • 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