Job Title

Applied Pharmaceutical Innovation (API) brings lifesaving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. APA is driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake. When you join API, you become part of a rapidly growing team that creates collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canadas life sciences sector. Job Overview The QA Validation / Change Control CSV and GMP Qualification role is responsible for providing Quality Assurance oversight and approval authority for the validation and qualification of computerized systems, IT infrastructure, and GMP Validation Qualification of facility utility equipment, systems and QC/Micro equipment/instrument and processes. The role ensures that Validation Qualification and 21CFR Part11 are applied, maintained, and performed in compliance with cGMP, Health Canada, FDA, 21CFR Part11, 21CFR Part210 &211, EU Annex11, ICHQ7, GAMP5 requirements and internal API procedural requirements using a riskbased approach. This position serves as a QA subjectmatter expert (SME) for computerized systems and GMP Validation Qualification, providing guidance on regulatory compliance, and supporting inspection readiness and audit activities. The QA Validation/Change Control ensures a riskbased approach to validation, promotes data integrity, and ensures systems remain in a compliant and inspectionready state throughout their lifecycle. Please note this position requires fulltime onsite presence. Key Responsibilities Provide QA oversight and approval for the validation and qualification of GxP computerized systems and GMP Validation Qualification, including IT infrastructure, manufacturing facilities, equipment, utilities, system, and QC equipment/instruments (FEU, S. and QCEI). Ensure validation activities are performed in compliance with cGMP, Health Canada, FDA, 21CFR Part11, 21CFR Part211, EU Annex11, ICHQ7, GAMP5 requirements and internal API procedural requirements. Act as the QA SME for validation strategies, documentation and acceptance decisions. Provide QA oversight and approval for software patch changes to computerized systems and GMP equipment, including impact and risk assessment. Review and approve deviations, incidents, CAPAs, and periodic reviews related to computerized systems and equipment validation. Validation Lifecycle Governance Govern the full validation lifecycle, including risk assessment, validation planning, qualification execution, and ongoing lifecycle maintenance. Provide expertise and solutions to issues regarding qualifications and validation strategies and documentation. Review and approve key validation deliverables, not limited to Validation Risk Assessment, Validation Plans, URS, FRS, configuration and design specifications, IQ, OQ, PQ protocols, traceability matrix and validation summary reports. Ensure systems and equipment remain in a validated and inspectionready state. Monitor and maintain audit trails and data integrity for all validated systems. Change Control (GMP Change Control and IT Change Control) Serve as change control expert for documentation of electronic change control documentation. Lead change control meetings. Control the electronic change control process as SME. Oversee change controls impacting validated computerized systems and equipment. Evaluate the impact of software, configuration, or equipment changes and define revalidation requirements. Risk Management & Data Integrity Ensure riskbased validation approaches are consistently applied across Validation Qualification and 21CFR Part11/Annex11 Computer System Validation and IT Infrastructure Qualification. Promote and support adherence to data integrity (ALCOA+) principles in computerized systems, Validation Qualification and QC equipment/instruments. Provide QA input to business continuity and disaster recovery planning for GxP systems. CrossFunctional & Vendor Oversight Partner with Engineering, IT, Manufacturing, QC, and Quality Systems to align validation expectations early in projects. Interface with supplier qualification for oversight of vendors and service providers, including review of validation packages and technical documentation. Support supplier qualification objectives and ongoing activities. Governance, Standards & Mentorship Lead, mentor and guide CSV and validation personnel; promote a strong quality culture. Develop, maintain, and improve CSV and equipment validation SOPs, standards, and templates. Drive continuous improvement initiatives to optimize validation efficiency while maintaining compliance. Qualifications Education Bachelors degree in a related field is required. QA Engineer Certification is an asset. Experience At least 3 years of experience in handling validation projects for computerized systems, qualification validation FEU, S., and QCEI in pharmaceutical, medical device industry or biologics. Expertise in the application of Health Canada and FDA cGMP requirements including 21CFR Part11, 21CFR Part210 &211, EU Annex11, ICHQ7, GAMP5 requirements and internal API procedural requirements. Knowledge of GAMP5 guidance pertaining to highly complex automated electronic systems for quality and manufacturing/packaging and engineering operations. Expertise in electronic quality management systems (QMS), QMS product management, and systems validation. Ability to drive requirements to closure and work with Quality to develop guidelines and procedures to formalize and educate colleagues on data integrity, ALCOA+. Demonstrated analytical and conceptual problemsolving skills and the ability to synthesize and clearly communicate complex findings to various stakeholders. Personal Competencies Strong customer focus with a demonstrated ability to work seamlessly with business sponsors and technologists. Exhibits curiosity, a commitment to learning, and exploring new technology. Fosters a transparent, honest, and positive team environment. Resultsoriented and processdriven, with high expectations of self and the team. Excellent communication skills with demonstrated experience in making articulate and effective oral presentations to different audiences. Ability to build constructive business relationships and gain the trust of others. Proven ability to lead, persuade, and influence. Must be selfconfident, outgoing, and able to communicate effectively upward and downward the management chain. Working Conditions Required travel between Edmonton API sites. This position requires you to be on site. Perks and Benefits at API Comprehensive Health Coverage premiums are 100% covered for employees and dependents. Retirement Savings RRSP Matching Program up to 13% of base salary. Professional Development Opportunities access to training programs, workshops, conferences, and certifications. Collaborative and Inclusive Environment a supportive atmosphere that values teamwork and diversity. Generous Paid Time Off includes vacation days, medical/personal days, and holidays. Green Transit Allowance eligible employees can enroll in the program to use environmentally friendly modes of transportation. Work From Home eligible employees are entitled to 20 remote work days, subject to job function, company needs, and manager approval. Equal Opportunity Statement Our team, clients, and stakeholders come from a variety of backgrounds. In recruiting for our team, we welcome the unique contributions that all people bring to the workplace in terms of varied lived experiences, education, culture, gender, race, sexual orientation, religious or ethnic background, neurodiversity, and cognitive and physical ability. Before employment, successful candidates will be required to meet the requirements of a preemployment screening, which includes background reference checks, educational credential verification, and criminal reference checks. Applicants with education credentials earned outside of Canada should have their credentials evaluated by World Education Services or the International Qualifications Assessment Service (IQAS). #J-18808-Ljbffr