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:
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
