Senior Quality Assurance Specialist
3 weeks ago
- Perform adherence checks as applicable
- Facilitate and/or Lead product complaint/inquiry requests, investigations and trending as per client or Kuehne+Nagel requirements
- Monitor temperature conditions of the facilities if applicable review inbound product temperature conditions;
- Maintain site documentation control and records retention for all local forms, WIs, SOP's, and client specific documentation
- Review, sign off, and oversee QA records such as certificates of destruction, calibration records, sanitation, etc.
- Facilitate deployment and development of training strategies
- Train and oversee Level I and II staff as assigned
- Support Operations in the maintenance of the site training program and applicable documentation;
- Oversee and/or execute development and implementation of change controls, WIâs, and SOPâs using working knowledge of GMPâs and industry standards
- Support the development of pro-active strategies as preventive measures against potential future issues within the QMS
- Assist QA Manager with new client / product onboarding / setup preparation
- Oversee day to day activities of QA Specialists, monitoring of work quality and productivity as assigned by the QA Manager
- Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology or a related discipline) is required
- 5+ years industry experience in Medical Device/Pharmaceutical industry in QA
- 3+ years industry experience in Medical Device/Pharmaceutical distribution site is preferred
- Meet Health Canada's requirements to perform RPIC and QPIC responsibilities
- Strong knowledge of Quality Management systems and standards (i.e: GMP, ISO 13485, ISO 9001)
- Proficiency in French (written and verbal) an asset
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