Quality and Validation specialist

4 weeks ago

Alliston ON, Canada ALTEN Canada Full time

SUMMARY OF RESPONSIBILITIES• Coordinate and execute the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating/compiling and/or reviewing validation packages, providing technical expertise and information resources to other departments and ensuring compliance to Regulatory and Corporate requirements.• Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies, Health Canada, and ISO requirements.• Utilize the Trackwise system for Change Control Management practicesESSENTIAL DUTIES AND RESPONSIBILITIESDetail the major responsibilities/activities of the job in 3 to 6 statements.Record responsibilities in order of most to least time spent. Record % of time spent in left margin.Time Spent Major Responsibilities / Activities50% • Create validation packages for systems, processes, cleaning procedures, analytical methods and equipment to demonstrate a validated state of control• Write protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages• Coordinate validation and IQ/OQ/PQ activities with Production, Quality Control Laboratories and outside contractors providing leadership, training and guidance• Monitor and support the execution of the protocols through training, facilitating and problem solving activities30% • Provide guidance and assistance on validation formats, requirements and procedures as a team member on various validation projects• Support validation training for team members and provide resource information as a technical expert• Review completed validation packages for compliance with validation requirements10% • Manage the validation status of the facility and ensure change control by maintaining the facility Master Plan as a current document, and tracking all validation efforts via schedules & status logs• Maintain the Site Reference File10% • Establish and manage the Validation Maintenance schedule• Prepare or assist in the preparation of Validation Maintenance packages• Manage the cleaning validation program and update the Cleaning Validation Risk Assessment document, adding new products and equipment as required• Contribute / participate in facility Quality review meetings• Participate as the Validation SME during Regulatory and Corporate compliance inspections• Support the Quality System Improvement Plan (QSIP) by ensuring that quarterly Quality Quotient assessments are completed and opportunities are identified and action plans created.Education/ExperienceEducation LevelRequired:• University Degree, Bachelor of Science•Major Subjects / SpecialtiesRequired:• Science (Chemistry, Microbiology, Pharmacy, Engineering)Preferred:• Experience working with pharmaceutical liquids processing systemsType of ExperienceRequired:• Previous experiences in GMP environment• Knowledge of GMP, ISO and Regulatory standards• Excellent written & oral communication skills required for writing commissioning & validation test plans, and final reportsPreferred:• Experience with liquid processing equipment is an asset.• Knowledge of Corporate Quality requirementsYears of ExperienceRequired:• 2-3+ years experience in a GMP regulated environment (preferably in the Biotech, Pharmaceutical, CPG or food industry)Preferred:• 5+ years experience in a GMP regulated environment (preferably in the Biotech, Pharmaceutical, CPG or food industry)Additional Skills / Special Training / Technical Skills RequiredRequired:• Strong understanding of Health Canada GMP and Medical Device Regulations.• Thorough knowledge of applicable procedures, specifications, regulations and standards.• Strong process and project management capabilities.• Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.• Ability to build strong relationships with internal and external customers.• Strong ability to balance multiple priorities.• Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.• Strong analytical and problem solving skills and critical thinking abilities.• Intermediate to Advanced proficiency in Word, Excel, Powerpoint.• Solid understanding of statistical tools/techniquesPreferred:• Basic understanding of computer system validations• Certified Greenbelt / Blackbelt designation.• Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.• Proficiency in Trackwise System• Comprehension/Proficiency of Minitab

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