Quality Assurance Specialist (18-Month Contract)

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing , producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our “Together, Beyond Animal Health” vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Your missions :

Quality Assurance Specialist

At local level, conduct audits of the activities and projects as appropriate. Act as the lead auditor for complex/external audits.

Responsibilities:

Right Level of Quality & Strategy

• In their field of expertise, implement and improve the quality system.
• May release non GMP/GMP Product and materials (including investigational product).
• Is accountable for quality related decisions within or without project management (depending on seniority level)
• Can approve product related deviations and action plans.
• Complete the assigned CAPA, change control or any other assigned action in due time.

QMS & Documentation

• Write QMS documents.
• May approve SOPs in their area of expertise.

Community Building and Activation

• Ensure continuous improvement in the production process in relationship with local stakeholders.
• Build training modules and animate quality training sessions.

Audits & Inspections

• Conduct audits of studies, investigator sites, Contract Research Organizations and Contract Manufacturing Organizations, internal audits as appropriate.
• May host inspection.
• Auditing (Internal/External) – Perform and document audits. Determine corrective and preventive actions (CAPA) through negotiation with internal and external stakeholders.

Other Responsibilities

• Product Quality Review (PQR) – Collect data and perform trend analysis. Write annual PQR reports.
• Supplier/Vendor Qualification – Administrate the supplier qualification program. Collaborate with suppliers and vendors. Generate supplier questionnaire and collect data. Maintain records and database.
• Support for Qualification/Validation activities – Executing protocols in whole or in part. Contribute the protocol generation. Organize or conduct sampling as required.
• Environmental Monitoring (EM) program – Help organize and support EM scheduling and sampling. Collect and analyze data. Support aseptic qualification activities.
• Pest Control Program (PCP) – Monitor and collect PCP data. Coordinate activities with PCP service provider.
• Deviation Investigation – Investigate deviations, determine root cause, and document results. Determine and/or complete CAPA as required. Collect and analyze deviation trend data.
• CAPA/Change Control – Complete CAPA and administrate change control process as assigned.
• Training – conduct or assist in training activities within the relevant area of expertise.

Other duties as assigned.

Competencies:

• Drive Ambition & Accountabilities

• Influence Others

• Collaborate with Empathy

• Engage & Develop

• Shape Solutions out of Complexity

• Client Focus

Qualifications

• Post-secondary degree/diploma in biological sciences or related field preferred.

• Post-secondary degree/diploma in Quality Assurance/Control ideal.

• 3 years in a Quality Assurance role in which you were involved in the development and administration of quality assurance systems.

• Previous experience in pharmaceutical or similar industry.

• Previous experience within a GXP environment.

Disclosures:

• This requisition is for a current opening at our Guelph, ON facility
• Targeted compensation range is between $65-75k annual salary but may vary dependent upon education, skills and experience

Your profile :

Qualifications

• Post-secondary degree/diploma in biological sciences or related field preferred.
• Post-secondary degree/diploma in Quality Assurance/Control ideal.
• 3 years in a Quality Assurance role in which you were involved in the development and administration of quality assurance systems.
• Previous experience in pharmaceutical or similar industry.
• Previous experience within a GXP environment.