Quality Assurance Associate - Hamilton, Canada - AtomVie Global Radiopharma Inc.

AtomVie Global Radiopharma Inc.

Verified Company

Hamilton, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

AtomVie is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals.

We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

About the Role*
What You Will Do

Support technology transfer and validation activities of investigational and commercial products and processes; including review and assessment of executed batches records and any relevant associated data (e.g., testing data OOS, nonconformances, change controls and CAPAs, etc.)
Support assigned projects and ensure that high quality standards are met within the projected timelines and project outcomes are compliant with internal/external requirements and GMP regulations
Participate in client and internal project team meetings and address any issues in a timely manner
Detect, report, and proactively propose solutions to challenges to ensure compliance with AtomVie's internal standards as well as regulatory standards.
Review standard operating procedures (SOPs), MBRs, STMs and other controlled documents for compliance with CAPAs, change controls, regulations and as per client requirements as needed
Review validation and stability protocols for compliance.
Review reports for compliance with protocols, quality systems, regulations and client requirements.
Conduct internal training of staff where needed
Update job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; and participating in professional organizations
Develop and maintain an indepth knowledge of key regulations and guidance documents, pertinent to Product Development and Quality Assurance and use this knowledge to improve the quality management system
Initiate and support improvement initiatives in favor of the development and growth of the AtomVie's quality management system.
Support the growth and development of AtomVie's Quality Management System in accordance with Health Canada and FDA regulations, ICH Q10 and ISO guidance
Complete any other related duties that support the core activities and mission of AtomVie, as required

Experience Required*- Post-secondary education in Engineering, Chemistry, Microbiology or a Science field

Minimum 35 years of relevant experience working in Biotech/Pharmaceutical/Radiopharmaceutical industry; experience in sterile products is considered an asset
Deep understanding of Health Canada, FDA and EU GMP regulations

What You Bring to the Role*- You are familiar with GMP, Method & Process Validation and Technology Transfer

Ability to support improvements and interact with internal and external stakeholders
Excellent communications skills in both written and spoken English
Agile responsiveness and flexibility to industry and business needs while maintaining a detailoriented and compliant outlook
Strong clientfacing, teamwork and organizational skills

AtomVie Offers: