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Quality Systems Specialist
4 months ago
The Quality Systems Specialist is responsible for maintaining and continuous improvement of the site Quality Management System throughout their knowledge and areas of expertise.
Ensure that objectives are effectively achieved, consistent with site requirements to ensure compliance, safety and reliable supply to our customers.
Primary Responsibilities:
- Provide quality support to the project and site, including training and guidance on the interpretation and implementation of site Guidelines / Policies and regulatory requirements.
- Provide expertise on deviation management, change control management, quality systems management, document / SOP management, GMP training & knowledge management.
- Ensure the health & well being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs
- Serve as support for metrics management for site deviation management and change control systems.
- Support the review and approval of site deviation and investigations reports.
- Support the site change management process.
- Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
- Day to day management of Deviation CAPA and Change Control metrics
- Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
- Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
- 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
- Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
- Experience with new product introductions and/or process qualification/technology transfer
