* Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
* Review and Approval of electronic and paper production batch records
* Daily presence and support on the manufacturing floor
* Release of Raw Materials for production
* Support the Technology Transfer of a new product into the site including raw material and supplier qualification.
* Support quality systems on site
* Review and approve new or updates to standard operating procedures (SOPs) and master batch records
* Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
* Review and approve Change Control documents
* Assist with regulatory inspections.
* Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives
* Compile and present metrics
* Other duties as assigned
* Minimum 4 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.
* Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
*Experience and ability to work cross functionally
* Experience in supporting manufacturing operations and batch record review is highly desirable
* Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
* Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
* Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
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The Life Science Specialists