מגייס: רותם שמיר מנהל קשרי לקוחות: רותם שמיר
תיאור
QA Manager - Validation and Change Control
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: Bachelors 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:
Strong verbal and written communication skills in both Hebrew and English.
High proficiency in English (reading, writing, speaking).
This position is open to all candidates.