Quality Assurance Officer

1 day ago

St Catharines, Canada Biolyse Pharma Full time

**Job description**

**Biolyse Pharma**
**Situated in St Catharines, Biolyse Pharma is a sterile manufacturing company that produces oncology products. **We are seeking a highly skilled and motivated Senior QA Officer to join our dynamic team and play a pivotal role in ensuring the safety, efficacy, and quality of our pharmaceutical products.

**Key Responsibilities**:

- **Quality Oversight**: Oversee and manage quality assurance activities, including the development, implementation, and maintenance of QA policies and procedures to ensure compliance with Health Canada and other regulatory bodies.
- **Audit Management**: Plan, conduct, and report on internal and external audits. Address audit findings and oversee corrective and preventive actions (CAPAs).
- **Compliance Monitoring**: Monitor and review batch records, quality control testing, and documentation to ensure all products meet quality standards.
- **Release of Drug Products**: Evaluate and approve drug product batches for release, ensuring compliance with regulatory standards and internal quality specifications.
- **Regulatory Affairs**: Collaborate with regulatory affairs teams to ensure all products are compliant with regulatory requirements and industry standards.
- **Training & Development**: Develop and deliver training programs for staff on quality assurance processes, GMP (Good Manufacturing Practices), and regulatory requirements.
- **Continuous Improvement**: Identify and implement continuous improvement initiatives to enhance quality processes and systems.
- **Problem-Solving**: Investigate and resolve quality issues, deviations, and non-conformities in a timely manner.

**Qualifications**:

- **Education**: Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, or a related field.
- **Experience**: Experience in quality assurance within the pharmaceutical industry.
- **Knowledge**: Deep understanding of GMP guidelines. Familiarity with ISO standards is a plus.
- **Skills**: Strong analytical, problem-solving, and decision-making skills. Excellent communication and leadership abilities.

**How to Apply**:
**Job Types**: Full-time, Permanent

Pay: $21.00-$25.00 per hour

Expected hours: 40 per week

Work Location: In person

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