Generation and review of annual product quality review reports and ensure adherence to approved schedules.
Co-ordination of stability data from suppliers by the request of stability data from contract laboratories, review of data following analysis and logging and filing of stability trend sheets.
Identification of and management of deviations and CAPAs, ensuring completion within stated due dates.
Maintaining complaint samples.
Supporting change controls.
Assist in New Production Introduction and product transfer processes.
Generation and submission of Quality System metric data.
Assist in maintaining site documentation such as Quality Manual, Site Master File.
Participating in internal and external inspections.
Maintaining communication with line management.
The minimum qualifications for this role are:
Bachelor’s degree in Science (equivalent / related industry experience).
2-3 years’ experience in a pharmaceutical or other life science organisation.
The ideal candidate will have previous experience managing deviations and CAPAs.
Good understanding of EU GMP.
Proficiency in speaking, comprehending, reading and writing English is preferred.
Qualifications
Third level qualification in a Science or Engineering
Skills
Experience
2-3 years
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