Dirección
forma de trabajoYour Role
As the Quality Assurance Specialist, you will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local level within the assigned business unit(s), in accordance to Distribution and/or Wholesaling requirements, as applicable. This role will execute branch Quality functions employing knowledge including but not limited to: corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). The ARPIC will assume full responsibility for all transactions involving precursors. You will report to the Contract Logistics Quality Manager.Your Responsibilities
- Support local Management within the Corporate Quality organization while maintaining site compliance to all Federal, Provincial and Local Quality requirements, as applicable to Distribution and/or Wholesaling activities.
- Assist the flow of Operations including Inbound, Returns, Destruction, Outbound, Retention etc. where Quality support may be required;
- Release and/or quarantine product in accordance to client or Kuehne+Nagel instructions and regulatory requirements;
- Inspect finished products and oversee the sampling of these products for testing and retention purposes in accordance to client or Kuehne+Nagel requirements;
- Support product complaint/inquiry requests or investigations in accordance to client or Kuehne+Nagel requirements
- Monitor temperature conditions of the facilities and if applicable review inbound product temperature conditions;
- Maintain site documentation control and records retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation;
- Review and sign off on QA records such as certificates of destruction, calibration records, sanitation, pest control, training, etc.;
- Support operations in the maintenance of the site training program and applicable documentation;
- Review and reporting of non conformance and planned deviation reports to ensure they are addressed at site level, including root causes completeness and timely implementation of CAPAs;
- Support operations in the completion of non conformity and planned deviation reports
- Support client audits, internal facility audits and external audits on behalf of KN;
- Support audit remediation activities
- Perform adherence checks as applicable
- Monitor the daily operational transactions of CDS (Controlled Drugs and Substances) /PCR (Precursor Control Regulations) products and fulfill regulatory reporting obligations per OCS (Office of Controlled Substances) regulations;
- Support the monitoring, and tracking of KPIs
- Support continuous improvement initiatives developed by Site QA Manager / Operations
- Support new client / product onboarding / setup preparation
If you require an accommodation for the recruitment /interview process (including alternate formats of materials, or accessible meeting rooms or other accommodation), please let us know and we will work with you to meet your needs.
Your Skills and Experiences
- Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, or a related discipline) is required
- 1-3 years industry experience in Medical Device/Pharmaceutical industry in QA. RA experienced may be considered 2+
years industry experience in Medical Device/Pharmaceutical distribution is preferred - Meet Health Canada's requirements to perform A/RPIC and A/QPIC responsibilities
- Basic knowledge of Quality Management systems and standards (i.e.: GMP, ISO 13485, ISO 9001
- Basic knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial regulations and guidelines
