Validation Qc Specialist

5 days ago

Anjou, Canada Cryopak Full time

Under supervision of the CVT QA /Services Director, this position is coordinate for all segments of the quality/validation functions. Responsible to coordinate, developping and implementing Quality/ validation processes to ensure products and services meet with appropriate regulatory agency requirements, internal company standards and current industry practices. Coordinates and reviews quality /validation area processes and procedures, making recommendations for changes and/or improvements in conjunction with our regulatory service/instrumentations/R&D teams.

1.Write /execute / reviews (protocol generation, execution, and final package preparation) process validation/quality activities related to the implementation of process changes and new processes while exercising judgment with broadly defined procedures and practices to establish approval criteria, identify and implement solutions to meet CVT and Regulatory Agency Requirements.
- Ensure that agreed section and project timelines are implemented and achieved.
- Ensure work is in line with regulatory requirements and guideline

2.Co-ordination the mapping /Thermal equipment’s/ system validation project expectations with CVT Pharma clients
- Collect and data trend reviews of mapping /validation projects.

3. Identifies, implements improvements and reviews to the QA/QC Process (Policies, SOPs, and technical Quality documentation to support regulatory /instrumentations / R&D practices) to meet CVT and Regulatory Agency requirements
- Maintain familiarity with laboratory operating, quality assurance/quality control procedures, quality system regulations and standards in order to assist the Team leader and Quality Manager

4. Create and execute testing plans and procedures according to the most appropriate methodology, report anomalies and follow their corrections with the R&D team.
- create and prioritize bug reports with clear reproduction steps

5. Conduct the team meetings and provide employee training on compliance related topics, policies and or procedures
- a. Train staff in validation activities, to provide the right level of support required to achieve workload.
- b. Work cross-functionally with other departments or teams and attend meetings as required.

**You will be**:
1. Bilingual (French & English)

2. Knowledge of GMPs guidelines, and process validation/ QC.

3. Experience of writing protocols and reports

4. Experience of raising, completing, and investigating quality records.

5. Proficient in Microsoft Word and Excel & Computerized Monitoring System.

6. Excellent organizational and prioritization skills and methodical attention to detail

7. Understanding of accessibility and usability best practices

8. Clean driver’s license 50% Travel

9. +3 years’ experience in pharmaceutical /biotechnology technical operations experience (e.g. Quality Assurance / Quality control /validation)

10.College diploma in science, industrial pharmacy or related discipline.

**Why work for Cryopak**

70% group insurance premium paid by employer

6 sick days

Vacation entitlement greater than CNT santands

Family oriented company

RRSP 3% match

Parking on ste

Telemedice

Carreer development

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