Specialist, Validation

Job purpose

The Validation Specialist is responsible to lead validation activities and provide expertise for the generation, execution, modification and summation of Validation documents of equipment (manufacturing and laboratory), processes, cleaning, sanitizing and facilities aspects of SunPharma Canada’s manufacturing site that may affect the quality of the product produced or tested. This is accomplished through interaction and co‑ordination of activities with all relevant departments within the organization.

Duties and responsibilities

• Ensure validation programs are established and maintained and provides feedback to generate accurate lists to ensure Master Plan objectives and schedules are met working within the constraints established by the production schedule.

Prepare Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ / OQ / PQ / Process). Ensure protocols provide :

Responsible and accountable for the execution of Validation Protocols including :

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

Working conditions

Physical requirements

Office based – 5 days on‑site

Direct reports

NA

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