Quality Assurance Associate - Hamilton, Canada - Centre For Probe Development And Commercialization

Centre For Probe Development And Commercialization

Verified Company

Hamilton, Canada

2 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

Reporting to the Supervisor, Quality Assurance Operations, the

Quality Assurance Associate will help to ensure GMP compliance during production of radiopharmaceuticals. This position will act as an interface between quality, radiopharmaceutical development, regulatory and production to ensure that all regulated activities listed below are conducted in compliance with relevant regulations and internal procedures.

Location:
Hamilton (On-site)

What You Will Do

QA activities associated with supply of AtomVie products; these include review of nonconformance reporting and investigations, follow up with CAPAs and change control.
Participate in Batch Record Review to release marketed and clinical products for use, as well as retrospective Batch Record Closeout.
Review standard operating procedures (SOPs), Master Batch Records, Standard Test Methods and other controlled documents for compliance with regulations and propose changes for review and approval.
Review and approval of specifications for incoming raw materials and for finished products.
Review stability protocols for compliance.
Review reports for compliance with protocols, quality system and regulatory requirements.
Support maintenance and improvement of the Quality Systems.
Represent Quality Assurance on project teams.
Provide support to internal and external audits by the AtomVie and participate in regulatory inspections of AtomVie facilities, as needed.
Assist in drafting and finalizing Annual Product Quality Reviews.
Develop and maintain an indepth knowledge of key regulations and guidance documents, pertinent to Quality Assurance and use this knowledge to improve the quality system; participate in building the AtomVie Quality System according to Health Canada, EU and FDA regulations, ICH Q10 and ISO guidance.
Other duties as assigned

Skills & Experience Required

A B.Sc or M.Sc in the life sciences with 15 years of experience in a GMP or equivalent regulated environment
Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records
Strong understanding of Health Canada, FDA and EU GMP regulations, with specific knowledge of the regulations as they pertain to sterile products
Proficiency in the English language both written and oral and excellent communication skills; detailoriented
Ability to work independently with mínimal supervision
Flexibility in work schedule to support a 24/7 production environment

AtomVie Offers: