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Phibro Israel is hiring a SLS Leader & QA specialist, for the Beit Shemesh site

Responsibilities

Overall responsible for the management of the SLS

Act as the main contact for any issue related to the Seeds

Set and write company policy and related procedures in support of SLS management (e.g. specification, manufacturing instruction if required, etc.)

Lead gap analysis for prioritization products based on management decisions followed by risk mitigation plan

Execute approved risk mitigation plan through completion including final report

Support SLS routine day-to-day activities

Coordinate interdisciplinary team meetings once a month and follow action items

Responsible for SLS electronic/hard copy documentation

Supervise seed storage and release for manufacturing

Work together with R&D to establish working procedures for Archive SLS

Support SLS for product development and manufacturing

Responsibility for handling deviations, while performing risk management accordingly and a CAPA plan

Improving existing processes and implementing new processes

Responsibility for handling/supporting change controls

A QA main pivot in the plant/ R&D projects as far as quality is concerned, working directly with managers

Qualifications

Preferably M.Sc. degree in Life Sciences/Biotechnology/ Veterinary

Minimum 2-4 years of relevant experience in biotech or pharmaceutical industry

Experience and biological understanding required - mandatory

Project management experience

Expert level knowledge of GMP regulations, Guidance documents, and industry best practices

Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, EMA, and ICH

Experience in quality assurance methodologies (change controls, CAPA, deviations, risk management, etc.)

Previous relevant experience in regulations and standards including USP / Ph. Eur, GMP, EMA, and ICH

High-level English- Mandatory