Quality Assurance Associate (Contract)

Auro Pharma Inc.; Vaughan; On-site; CAD 60,000 - 75,000; Full time

Job summary

Auro Pharma Inc. seeks an Associate-Quality Assurance for a maternity leave contract to support quality activities and compliance with GMP standards. The role includes reviewing documents, managing records, and assisting during regulatory inspections. Ideal candidates must hold a B.Sc. and possess QA experience in pharmaceuticals.

Benefits

Attractive compensation package

Opportunity for growth

Qualifications

• Minimum of 2 years Quality Assurance experience in pharmaceuticals.
• Knowledge of cGMP regulations required.
• Bilingual French is a plus.

Responsibilities

• Assist QA Head with quality control and compliance activities.
• Review Batch Release documents and maintain GMP records.
• Prepare standard operating procedures and assist in regulatory inspections.

Skills

Communication

Management skills

Fast-paced work capability

Education

B.Sc. degree in Chemistry, Biology, Pharmacy, Microbiology

Tools

MS Office Suite

Job description

3 days ago Be among the first 25 applicants

Type: Maternity leave contract ( for 1 year) with possible extension

Company Profile

Auro Pharma Inc. is a Canadian subsidiary of Aurobindo Pharma. (www.auropharma.ca)

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.

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

• B.Sc. degree in Chemistry, Biology, Pharmacy, Microbiology or a similar discipline
• Minimum of 2 year Quality Assurance experience in a 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.

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 [e-mail] .

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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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