Senior Quality Assurance Associate

Found in: Jooble CA O C2 - 2 weeks ago

Toronto ON, Canada Auro Pharma Inc. Full time

Company Profile

Auro Pharma Inc. is a Canadian subsidiary of Aurobindo Pharma. (

Aurobindo Pharma is a vertically integrated company manufacturing Drug Intermediates, API, Finished formulations, Research & Development. The group has 300 APIs and 500 formulations selling in over 130 countries with 19000 employees worldwide.

Auro Pharma Inc. is classed as #1 in growth for the past three years in Canada. We have a large basket over generic prescription products both orals and Injections in key therapeutic areas, Anti-Infective, Anti Retro Viral, Cardio Vascular, Central Nervous System and Pain Management. Auropharma has distribution and sales across Canada in Hospitals, Retail and Corporate.

Auropharma offers attractive compensation package, benefits and opportunity for growth to the right candidate.

Summary of Position

The Associate-Quality Assurance will assist the QA Head to provide proactive approach to identifying, evaluating, and controlling potential risks to quality and ensure continual improvement of process performance and product quality throughout products lifecycle.

 

The Associate-Quality Assurance will assist the QA Head to ensure that all Quality activities are completed in compliance with the current Good Manufacturing Practices and the Food and Drug Act.

 

Responsibilities

  • Review and consolidate Batch Release documents, coordinating with warehouse, manufacturing facilities, and testing laboratories to ensure timely lot releases. Prioritize Batch Release according to cycle time, customer expectations, and business requirements.
  • Maintain all GMP records in adherence to Good Documentation Practices. 
  • Possess training and expertise in documentation control, change control, deviations, CAPAs, and review of quality records.
  • Demonstrate comprehension of Health Canada, FDA, and EU GMP regulations, particularly regarding Pharmaceutical sterile and non-sterile products. 
  • Prepare, approve, and document all Release Records in accordance with Health Canada importer requirements.
  • Support the QA team lead in recall situations.
  • Aid the QA team lead during regulatory inspections and internal audits.
  • Review of OOS investigation.
  • Develop and/or review standard operating procedures as necessary.
  • Be available for extended hours and weekends when required, particularly during issue resolution or deadline-driven periods.
  • Fulfill other duties as assigned.

 

Qualifications

  • B.Sc. degree in Biology, Pharmacy, Microbiology or a similar discipline
  • Minimum 2 year Quality experience in a sterile pharmaceutical or drugs manufacturing
  • Knowledge and experience with cGMP regulations
  • Demonstrated effective management skills
  • Excellent communication skills, both written and oral, are required
  • Proficient in MS Office Suite software (Excel, Outlook, Word) and able to quickly learn new computer programs
  • Able to work in a fast-paced environment
  • Bilingual French is a plus.

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