Quality Consultant

RQC; Canada; Hybrid; CAD 75,000 - 110,000; Full time

Job summary

RQC is seeking a Quality Consultant to provide assurance services across regulated markets, including medicinal products, drugs, medical devices, and natural health products. The role involves remote or onsite project work, lifecycle management of quality systems, and validation activities.

Responsibilities include audits, regulatory submissions, and ensuring compliance with GMP, GLP, GDP, and GCP. Strong communication and organizational skills are essential to meet tight timelines and client

Qualifications

• Proficient in GMP, GLP, GDP and GCP concepts.
• Experience applying quality standards to regulated products.
• Ability to develop quality manuals, site master files and validation plans.
• Strong written and oral communication and presentation skills.

Responsibilities

• Provide QA consulting remotely or onsite for regulated industries.
• Manage lifecycle of quality systems and documentation.
• Qualification and validation of facilities, equipment, and computerized systems.
• Conduct supplier quality audits and GMP evidence.
• Develop and implement compliance approaches for licensing or remediation.
• Apply quality tasks across drug manufacturing and supply lifecycle.

Skills

GMP knowledge

GLP knowledge

GDP knowledge

GCP knowledge

Regulatory interpretation

Communication skills

Time management

Problem solving

Language skills

Education

QA/regulatory degree or diploma

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 computerized 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

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