Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Initiates, leads, and coordinates complex investigations with key cross-functional parties related to Deviation Reports (DRs). Responds to Packaging and Processing deviations, provides technical leadership for root cause investigations, develops and authors trend reports to identify recurring issues, systemic gaps, and emerging risks, and recommends proactive improvements to enhance compliance and operational performance.
Propose Corrective Actions Preventative Actions (CAPAs) to ensure root cause of investigations are addressed and prevent recurrence of the event.
Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements.
Track, trend, and monitor metrics for deviation investigations and related processes to identify trends and associated actions to mitigate risks and drive performance.
Prepare and present periodic trend reports that summarize investigation data, recurring issues, root cause patterns, CAPA effectiveness, and opportunities for continuous improvement.
Bachelor's degree in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment or College/Technical School diploma in pharmaceutical manufacturing, science or related field.
Minimum 5 years of manufacturing experience in the pharmaceutical, food, or cosmetic industry, including demonstrated experience leading complex investigations, technical/scientific writing, trend analysis, and cross-functional collaboration.
Compensation
The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.
