1. JOB OBJECTIVES
Provide support to the Production department through:
- Monitoring and documenting events and incidents to assess their impact on product quality.
- Conducting investigations: data collection, verification, analysis, and report writing.
2. PRIMARY FUNCTIONS
- Initiate, investigate, and close deviations within deadlines and in accordance with corporate procedures.
- Lead investigations and write incident and complaint reports.
- Assess trends in collaboration with the Quality Assurance team.
- Coordinate corrective actions related to incidents and organize meetings when necessary.
Other
- Participate, as needed, in drafting and updating the department’s Standard Operating Procedures (SOPs).
- Ensure compliance with health and safety rules (handling, behavior, etc.).
- Perform any other related duties deemed relevant to the position.
3. EXPERIENCE REQUIREMENT AND APTITUDES
- Bachelor’s degree in science or any other relevant education.
- Minimum of 3 years of experience in a similar position, preferably in the sterile pharmaceutical industry.
- Knowledge of Canadian and international Good Manufacturing Practices (GMP).
- Bilingual (French and English) with excellent written and verbal communication skills.
- Proficiency in computer tools, particularly the Microsoft Office suite.
- Strong analytical and synthesis skills, sound judgment, and problem-solving abilities.
- Experience in technical writing.
- Team spirit.
- Dynamism, rigor, autonomy, and attention to detail.
- Strong organizational skills and ability to manage priorities.
- Ability to work under pressure and meet tight deadlines.