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QE for External Operations - open for internal move

Description

QE for External OPS (reporting to QA lead)

Scope:
Quality engineer for external manufacturing and IVIG

Responsibilities:

This role combines 2 major aspects - IVIG release and LYO release including communication with EX-OPS suppliers.
- Full responsibility for EVICEL final release for ROW and IVIG release
- Approval of shipments (preparation and final after shipment)
- Support packaging department and visual inspections - write assessments, review investigations and release WS's
- Release protocols and contact with authorities before final release
- Works closely with planning department and ETHICON affiliates in the world in order to meet business needs and release on time
- Back up in 2022 and full responsibility in 2023 for all EX-OPS activities – release LYO batches (batch files review, issue CoA's, CoC's, CBER), responsibility on Grifols, Patheon and Ferrosan tasks (assessments, change controls, protocols, and development)

Requirements

- At least 3 years of experience in GMP environment
- At least 2 years of experience in QA
- English – high level
- Ability to work with multiply functions

Location: תל השומר

Comments

Omrix is an equal opportunity employer promoting diversity and inclusion in the work place.
This position may be suitable for any person subject to their qualifications and capabilities, regardless of (inter alia) gender, origin, ethnicity, sexual orientation, and/or disability.