Job Title

Senior Compliance & Laboratory Systems SpecialistJoin to apply for the Senior Compliance & Laboratory Systems Specialist role at Catalent.Position SummaryWork Schedule: Monday-Friday 8 AM-4:30 PM; potential future transition to 12hour shifts.100% onsite at the Adair site.The newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalents Zydis technology, a globally renowned, fastdissolve oral dosage form that has transformed the lives of millions of patients worldwide. At Adair, youll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing.Reporting to the Director of Quality, the Senior Compliance & Laboratory Systems Specialist ensures compliance with regulatory standards and internal policies, oversees electronic laboratory systems, and supports the companys quality management systems and qualification activities to ensure GMP compliance. This role serves as a key liaison between Quality Control, IT, Validation and Quality Assurance, ensuring data integrity and system validation across the site.ResponsibilitiesEnsure laboratory operations comply with GMP/GLP requirements, current governmentmandated regulations, and Catalent Global Quality Policies and Standards. Administer user accounts, roles, and system functions for electronic laboratory systems (e.g., LSA).Oversee laboratory calibration and equipment qualification activities to meet compliance expectations and collaborate with IT and Validation teams to maintain system compliance with 21 CFR Part 11 and data governance requirements.Participate in and approve data integrity assessments across laboratory and nonlaboratory systems, identify data integrity risks (DIARP), and support the development of improvement plans, including identifying data and system issues, defining requirements, and recommending enhancements to system functionality and related processes.Lead, coordinate, and participate in investigations and corrective action identification/implementation for Deviations & Laboratory investigation reports. Ensure ontime closure of deviations, LIRs, and corrective action/preventive action items.Act as Quality subjectmatter expert for the review and approval of SOPs, validation and qualification protocols, summary and trend reports, and change controls to ensure compliance with quality standards. Ensure Environmental Monitoring (EM), Purified Water (PW) monitoring, and cleaning validation programs fully meet regulatory requirements and established policies and procedures.Support sitewide quality improvement initiatives by contributing to project teams to execute key quality projects and drive continuous improvement of the Quality Management System by leading teams through the implementation of new systems, processes, and ways of working.Provide support during regulatory and customer audits, ensuring readiness and compliance; represent laboratory compliance during inspections.Perform other duties as required.Candidate ProfileBachelors degree in Life Sciences, Engineering, Computer Science or related discipline required.5+ years of experience in a Quality Assurance environment, ensuring safety, quality, and productivity.Experience in pharmaceutical or GMP facilities; laboratory experience preferred.Experience in Quality Management System & Validation, preferably within the pharmaceutical industry, highly desirable.Strong attention to detail and accuracy; experience generating, reviewing, and approving controlled documents.Knowledge of laboratory techniques, terminology, equipment, and materials; handson experience using electronic laboratory systems.Strong understanding of GxP requirements, 21CFR Part11, data integrity principles, and system validation.Excellent interpersonal skills with the ability to work effectively across all levels and functions, and to influence and motivate others to achieve results.NonCanadian credentials must provide an evaluation confirming Canadian equivalency (e.g., WES).Must be able to communicate effectively, sit for extended periods, use manual dexterity to operate a computer, and occasionally stand, walk, bend, stoop, kneel or crouch; close vision required. Ability to handle hazardous chemicals following safety procedures.PayThe anticipated salary range for this position in Ontario is $67,000 $82,000 per annum.BenefitsComprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)Group Retirement Savings Registered Pension Plan (RPP) with employer contributionsPaid Time Off ProgramsOpportunities for professional and personal development & growth including tuition reimbursementEqual Opportunity & AccommodationCatalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If an applicant requires reasonable accommodation due to a disability, please submit a request by email with the job number, title and location to . #J-18808-Ljbffr