תיאור תפקיד

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