Job Summary
The Validation Manager is responsible for Accuristix Inc site validation requirements ensuring compliance with the regulatory and industry standards. This includes all activities related to site & chamber mapping studies & HVAC qualification. The Validation Manager will execute site Validation Master Plans and ensure all requirements are met.
The Validation Manager is also responsible for equipment, warehouse and chambers qualification for Accuristix Inc as well as in-house calibration activities.
Duties and Responsibilities
- Execute and maintain Accuristix Inc Master Validation Plans for all sites. Execute re-qualification of facilities/equipment as required
- Ensure Accuristix Inc facilities & chambers are temperature mapped according to Health Canada guidelines and seasonality. Write protocols & reports.
- Ensure HVAC systems are qualified.
- Source mapping temperature sensors and ensure they are calibrated according to set schedule. Assess and address any issues.
- Identify hot & cold locations for all temperature mapped facilities & chambers.
- Recommend placement of temperature sensors in facilities/chambers according to identified hot/cold spots and outcome of mapping study.
- Generate sensor maps for all facilities/chambers and keep up-to-date.
- Ensure validation temperature monitoring system and review of major system changes for impact to validation.
- Support validation of shipping lanes and shipping containers. Write SOPs as required.
- Write SOPs related to temperature mapping & monitoring.
- Participate in writing, review & approval process for validation related policies & procedures.
- Ensure validation tasks are identified and completed for facility/chamber commissioning & decommissioning.
- Participate in review & assessment of change controls that may have a validation impact. Complete validation tasks as required.
- Assess Accuristix Inc equipment as GMP impacting and execute related risk evaluation.
- Validate all GMP equipment and identify re-validation requirements. Write validation protocols & reports.
- Identify equipment calibration & preventive maintenance parameters as well as acceptance criteria. Recommend calibration & preventive maintenance frequency.
- Oversee in-house calibration activities, equipment and area. Qualify calibration chamber and ensure preventive maintenance is executed at scheduled intervals.
- Execute calibration of temperature loggers/sensors and thermostat/controller devices following Accuristix Inc procedures. Investigate failures and review results.
- Ensure validation tasks are identified and completed for equipment commissioning & decommissioning.
- Train users as required on validation related processes.
- Mentor direct reports to develop and maintain a work environment that fosters employee excellence, employee development, strong teamwork, communication and support of core values.
- Escalate concerns to Senior Management.
- Support regulatory, Client & internal audits.
- Perform other duties as required.
Qualifications
- B.Sc. or equivalent work experience.
- 2 to 3 years experience in a pharmaceutical manufacturing or related environment
- Experience with validation
- Experience developing technical requirements documentation
- Excellent interpersonal and communication (both written and oral) skills
- Excellent project management, project documentation and organizational skills
- Knowledge of Canadian GMP regulations
Education:
- Bachelor's Degree (required)
Experience:
- pharmaceutical manufacturing or related environment: 2 years (required)
- validation: 1 year (required)
Work Location: In person
