|
|
| תיאור: |
Omrix, a J&J Bio-Pharmaceutical company is looking for a Process Technology Scientist for the Tel Hashomer site.
Job Description:
Utilizing sound scientific and engineering principles for problem solving and execution of continuous process improvements within the context of cGMP practices.
Duties & Responsibilities:
Responsible to work in conjunction with Manufacturing, Quality Assurance, Engineering, Regulation and Validation departments to support and troubleshoot existing operations, provide recommendations for process improvements.
Utilizing Process Excellence techniques to solve problems and develop optimal products and processes.
Partnering with R&D to ensure application of design controls and product risk management including investigation/correction of failures/challenges
Developing systems and processes regarding collection of data, analysis and reporting of production process trends, for example: Yields, OOS, and Deviations.
Contribute to the systematic of process related root cause investigations and management of process related CAPA.
Performing an on-going manufacturing process evaluation, identification of potential manufacturing risks and proposal of preventive actions with regards to process changes.
Leading risk assessment of manufacturing changes (pFMEA) to support appropriate controls and mitigation strategies, establishing a comprehensive risk management plan for both product and process performance.
Evaluation and ownership of process related Change Control.
Review of manufacturing procedures for compliance with quality standards and regulations and implementation of improvement opportunities
Providing manufacturing subject matter expertise to support validation department with Process validation and Process Qualification study design
Reporting to Product Support Manager
|
|
|
| דרישות: |
- B.sc / M.sc in life sciences or engineering.
- 3 years of proven former GMP experience in a pharmaceutical company.
- Prove experience in project management.
- Very high level of English
|
|
|
| היקף המשרה: |
מלאה |
עיר/ישוב: |
קרית-אונו |
תפקיד: |
איש צוות |
שנות ניסיון: |
|
|
|
