Quality Assurance Specialist

Job description

Lead investigations into quality incidents, deviations, and non-conformances, implementing corrective and preventive actions (CAPAs)

Provide guidance and training to team members on quality procedures, protocols, and GMP requirements.

Ensure that the Company’s quality system procedures and products are in compliance with regulatory guidelines, regulations, and external standards.

Perform controls and verify quality for all sub-contractors, suppliers, production processes and R&D

Ensure validation processes are performed and documented

Ensure compliance with in-house procedures through ongoing, periodic audits or inspections Review and approval of change controls, ensuring thorough evaluation and documentation of all changes impacting product quality according to the applicable risk management procedure

Review and approval of validation protocols and reports to ensure compliance with regulatory requirements and industry best practices

Conducting annual product reviews, communicating findings and recommendations to the management team

Conducting annual critical systems reviews and trend analysis.

Job requirements

A Bachelor’s degree in a technical or scientific discipline is required (preferred life science).

3-5 years of experience in quality assurance, in the pharmaceutical/Biotechnology industry Experience with quality management systems interactions and audits

Understanding of quality assurance in a regulated environment

Experience with manufacturing and validation processes

Familiar with quality management standards and methodologies (e.g., ISO, GMP, Eudralex Vol. 4 standards, Continuous Improvement)

Fluent English & Hebrew, and writing proficiency.

Location: lower Galilee