This is an 11-month initial contract.
Purpose The Quality Systems Compliance Specialist is responsible for maintaining and continuous improvement of our Quality Management System throughout their knowledge and areas of expertise.
Ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and reliable supply to our customers.
Responsibilities Provide quality support to the project and site, including training and guidance on the interpretation and implementation of our Guidelines / Policies and regulatory requirements.
The main areas of expertise are, but not limited to, specific tasks and roles such as: deviation management, change control management, quality systems management, document / SOP management, data integrity 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 maintenance of the site master file and site manufacturing license and variations, as required.
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, QRM 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.
Liaise directly with cross-functional departments to ensure that change control and deviation management system requirements are met.
Support Regulatory and Compliance Inspections at the site, as required.
Support for management of recalls, as required.
Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Build a Quality culture that delivers unconstrained supply, Right First Time to our patients.
Support Quality Risk Management process Requirements Over 4 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations.
Motivated to be an inspiring member of a high performing team.
Excellent interpersonal skills: communication, decision making, people influencing skills.
Ability to interact with multiple stakeholders.
Desire to continuously learn, improve and develop.
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.
Bachelors degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
Skills: Continuous Improvement Deviation Management Quality Systems SOPs CAPA