- Partner with cross functional GMP departments to ensure Drug Substance and Secondary Packed material is manufactured and release in accordance with GMP.
- Review and Approval of electronic and paper production/packaging 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.
- 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 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.
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
The shift is as follows (in a 6 week cycle):
Week 1, early shift: 6.30am to 2.30pm Mon to Thurs, 6.30 to 1.30pm Friday (premium of 16.66%)
Week 2, late shift: 2.30pm to 10.30pm Mon to Thurs, 2.30 to 9pm Friday (premium 16.66%)
Week 3, 4, 5, 6, standard day shift: 8.30am to 5pm Mon to Thurs, 8.30 to 4pm Friday.
If you are interested in this position, please apply directly or feel free to email Jackson Ford on firstname.lastname@example.org
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