Critical equipment and systems expert in quality assurance
Date: Jun 27, 2022
Location: Kfar Saba, IL, 1111
Company: Teva Pharmaceuticals
Company Info
Job Description
- Responsible for quality assurance of computerized systems (IT) and equipment and critical systems in manufacturing and packaging department (QA engineering).
- Consulting and guidance in quality assurance issues to Engineering department, Validation department and maintenance department
- Writing, reviewing and approving procedures regarding to QA IT and QA engineering.
- Review and approval of IT validation protocols, validation reports and validation schedules.
- Review and approval of risk assessments, engineering documents (URS, FS, TM), VP, VSR documents, equipment and critical systems drawings.
- Review and approval of engineering validation protocols.
- Review and approval of change control for IT, equipment and critical systems.
- Review and approval System development life cycle documents.
- Supporting and management IT deviations and engineering deviations.
- Leading of QA IT and QA engineering projects.
- Writing, reviewing and approving of rationales, risk assessments and general documents regarding to QA IT and QA engineering.
- Conducting suppliers inspections as needed
- Conducting internal inspections as needed
Qualifications
- Bachelor's degree in Mechanical Engineering / Biotechnology / Computers.
- At least 3 years of experience in pharmaceutical industry and familiarity with GMP procedures
- Experience of validation processes of machines, computerized systems, water systems and HVAC systems.
- Knowledge and experience in Office applications (Word and Excel).
- Good communication skills and ability to build and maintain relationships both internal and external
- Strong organizational and interpersonal skills
- Able to work independently with minimal supervision
- Ability to take decisions and drive progress in a complex ambiguous environment based on mix of analysis, experience, and judgment.
- High multitasking capability
- Ability to work under pressure conditions.
- High English level
Function
Sub Function
Reports To
Sr Manager Quality Assurance, Operational QA
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