Quality Assurance Associate

Company Profile

Aurobindo Pharma is a vertically integrated pharmaceutical organization heavily focused in research & development and in manufacturing drug intermediates, Active Pharmaceutical Ingredients (API) & finished formulations. The group has proven regulatory expertise, technology and know-how for speciality formulations. Aurobindo Pharma has a global network and customer centric approach.

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 compile Batch Release documents. Liaise with warehouse, manufacturing facilities and testing laboratory to facilitate the timely release of lots. Prioritize Batch Release based on cycle time, customer expectations, and business needs.
• Keep all GMP records in compliance with the Good Documentation Practices.
• Initiate deviation reports, prepare and execute Investigations, and ensure timely escalation to relevant stakeholders.
• Training and experience in documentation control, change control, CAPAs and review of quality records.
• Understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to Pharmaceutical sterile and non-sterile products.
• Assist the QA team lead in the event of a recall.
• Assist the QA team lead during regulatory inspections and self-audits.
• Assist the QA team lead in the investigation of complaints.
• Prepare and / or review standard operating procedures when required.
• Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.
• Perform other duties as required. Reports to : Director Quality Assurance

Qualifications

How to apply

If this opportunity interests you, and you meet all of the above requirements, please submit your resume and a cover letter stating salary expectations to  .

Auro Pharma Inc. offers attractive compensation package, benefits and opportunity for growth to the right candidate.

We thank all applicants for their interest, however only candidates selected for interviews will be contacted.