Quality Assurance Specialist

5 months ago

Guelph, Canada Ceva Animal Health Full time

Ceva is seeking a Quality Assurance Specialist who will play a vital role in enuring the quality of our Immucox vaccine line by conducting audits of the activities and projects as appropriate.

Ceva Animal Health Canada established itself in Canada with the acquisitions of CentaurVA Animal Health and Vetech Laboratories in October 2011. Our Canadian presence expanded during 2019 when we acquired IDT Biologika subsidiary Gallant Custom Laboratories manufacturer of autogenous vaccines.

Ceva offers an expanding range of products for companion animals, poultry, swine, and ruminants for Canadian customers.

**About the Role**

In this role you will conduct audits of the activities and projects as appropriate. Act as the lead auditor for complex/external audits.

**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.

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 Organisations 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 duties as assigned.

**About You**
- You have a post secondary degree/diploma in biological sciences or related field. Ideally, you have a post-secondary education in Quality Assurance or Quality Control.
- You have a minimum of 3 years in a Quality Assurance role in which you were involved in the development and administration of quality assurance systems
- You have previous experience in biologics, pharmaceutical or a similar industry
- You have previous experience within a GXP environment
- Ceva Animal Health - Canada is committed to accommodating any applicant with a disability, as required by law, during the recruitment, assessment and selection process. Please notify us if you require accommodation._
- We are an equal opportunity employer and consider all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status._

**Job Types**: Full-time, Permanent

**Salary**: $66,000.00-$75,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Dental care
- Disability insurance
- Discounted or free food
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- RRSP match
- Vision care

Schedule:

- Day shift
- Monday to Friday
- Weekends as needed

Work Location: In person

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