Specialist, QA Validation/ Change Control

API • Edmonton, AB

39d • Onsite

About The Position

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating 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 Canada’s life sciences sector.

The QA Validation/ Change Control – CSV and GMP Qualification 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. This role ensures that Validation Qualification and 21 CFR part 11 are applied, maintained, and performed in compliance with cGMP, Health Canada, FDA, 21 CFR Part 11, 21 CFR Part 210 & 211, EU Annex 11, ICH Q7, GAMP 5 requirements and internal API procedural requirements using a Risk based approached.

The position serves as a QA subject matter 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 risk-based approach to validation, promotes data integrity, ensures systems remain in a compliant and inspection-ready state throughout their lifecycle.

Please note this position requires full-time on-site presence.

Requirements

• Bachelor's degree in related field is required.
• At least 3 years of experience required in handling validation projects for Computerized system, Qualification Validation FEU, S. and QC-EI in pharmaceutical, medical device industry or biologics.
• Expertise in the application of Health Canada and FDA cGMP requirements including 21 CFR Part 11, 21 CFR Part 210 & 211, EU Annex 11, ICH Q7, GAMP 5 requirements and internal API procedural requirements.
• GAMP 5 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.
• Able to drive requirements to closure and work with Quality to develop guidelines and procedures to formalize and educate colleagues on needs and expectations of data integrity, ALCOA+.
• Demonstrated analytical and conceptual problem-solving skills and the ability to synthesize and clearly communicate complex findings to various stakeholders.
• 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.
• Results-oriented and process-driven, 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 self-confident, outgoing, and able to communicate effectively upward and downward the management chain.
• Required travel between Edmonton API sites.
• This position requires you to be on site.
• Applications submitted without a resume AND cover letter will not be reviewed.

Nice To Haves

• QA Engineer Certification is an asset.

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 QC-EI).
• Ensure validation activities are performed in compliance with cGMP, Health Canada, FDA, 21 CFR Part 11, 21 CFR Part 211, EU Annex 11, ICH Q7, GAMP 5 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.
• 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 inspection-ready state.
• Monitor and maintain audit trails and data integrity for all validated system.
• Serve as Change Control expert for documentation of electronic Change Control documentation.
• Lead Change Control meeting.
• 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 re-validation requirements.
• Ensure risk-based validation approaches are consistently applied across Validation Qualification and 21 CFR part 11/Annex 11 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.
• Partner with Engineering, IT, Manufacturing, QC, and Quality Systems to align Validation expectations early in projects.
• Intervace 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.
• 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.

Benefits

• Comprehensive Health Coverage: At API, we prioritize the well-being of our employees. We offer a comprehensive health coverage plan. Our premiums are 100% covered, ensuring that you and your dependents receive the necessary healthcare support.
• Retirement Savings: API offers a RRSP Matching Program. Employees may be eligible to participate, with API matching of contributions up to 1–3% of base salary, in accordance with program terms.
• Professional Development Opportunities: We foster a culture of continuous learning and growth. API provides access to various professional development opportunities, including training programs, workshops, conferences, and certifications. We encourage employees to enhance their skills, broaden their knowledge, and stay updated with the latest advancements in the life sciences industry.
• Collaborative and Inclusive Environment: At API, we believe in the power of collaboration and diversity. We foster an inclusive work environment that values and respects individuals from all backgrounds. We promote teamwork, open communication, and a supportive atmosphere where everyone's contributions are valued.
• Generous Paid Time Off: We understand the importance of taking time off to recharge and maintain a healthy work-life balance. API offers a generous paid time off (PTO) policy that includes vacation days, medical/personal days, and holidays. We encourage our employees to prioritize their well-being and enjoy quality time away from work.
• Green Transit Allowance: Employees based out of an office are eligible to enroll in our green transit program, which promotes the use of environmentally friendly modes of transportation. By participating in the program, you commit to making green transit your primary mode of transportation for at least 75% of your commute to and from work. Green transit includes walking, biking, carpooling, and public transportation.
• Work From Home: Eligible employees are entitled to 20 Work from Home days, this is subject to job function, company needs, and manager approval.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees