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QA Manager – Validation and Change Control

BTG A Ferring Company

אשדוד

QA Manager – Validation and Change Control

BTG A Ferring Company

אשדוד
מלאה
22,000-30,000 ₪ (הערכה מבוססת AI)
זוהי הערכת טווח שכר מבוססת AI ולא פרסום של המעסיק

Job Description:

Responsibility for managing team tasks: training, supervision, and coordination of team activities.
Review and approval of validation processes across multiple domains (equipment, process, cleaning, analytical methods, infrastructure, systems, cleanrooms, computerized systems).
Management of change controls and quality records (deviations, CAPA).
Authoring protocols and reports for process and cleaning validation.
Performing risk assessments and providing ongoing support for projects.
Writing and approving procedures in accordance with relevant standards.
Participation in regulatory inspections, internal audits, and supplier audits.
Leading quality improvement initiatives.
This position is open to all genders.

Requirements:

Bachelor’s degree or higher in one of the following fields: Biotechnology Engineering, Chemical Engineering, Pharmaceutical Engineering, Biomedical Engineering, Chemistry, Biochemistry, Biotechnology, Life Sciences, or Pharmacy.

Professional Experience: At least 5 years of managerial experience – required.

Experience in the pharmaceutical industry in a GMP environment – required.
Extensive experience in authoring, reviewing, and approving validation processes (equipment, process, cleaning, infrastructure) – required.
Experience in managing change controls and quality records – required.
Experience in writing SOPs, protocols, and reports.
Experience in leading and participating in regulatory inspections.

Skills:

High proficiency in English (reading, writing, speaking).

Excellent interpersonal skills and the ability to work in a dynamic, cross-functional environment.
Excellent presentation and communication skills, both verbal and written, in Hebrew and English.
Strong interpersonal skills and ability to work effectively with cross-functional teams.
High-level proficiency in English (spoken and written).