- 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 as assigned
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required
- Minimum 3 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.
- 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
'Not Just Placers.........Partners'
The Life Science Specialists