quality assurance officer
Posted on
September 18, 2024
by
Employer details
Biolyse Pharma
Job details
*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.
*Job Description:*
We are seeking a highly skilled and experienced QA Officer to join our Quality Assurance team. The ideal candidate will have a strong background in pharmaceutical quality assurance, with a proven track record of ensuring compliance with regulatory requirements and maintaining the highest standards of quality.
*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:*
Interested candidates should submit their resume detailing their relevant experience and qualifications through Indeed, alternatively resumes can be sent to info@biolyse.com
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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LocationSt. Catharines, ON
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Workplace information
On site
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Salary$21.00 to $25.00HOUR hourly
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Terms of employment
Permanent employmentFull time
- Start date
Starts as soon as possible
- vacancies
1 vacancy
- Source
indeed.com
#9451105785
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