Commercial Quality Manager & QP Israel
- רמת השרון
- משרה קבועה
- משרה מלאה
- Ensure a robust Quality Management system is in place and fit for purpose to comply with current regulations such as relevant GMP and GDP and Israelian Health Authorities requirements
- Lead and facilitate quality continuous improvement activities
- Implement processes and procedures and observe/audit for compliance
- Provide feedback to the Commercial Quality SE manager on performance
- Serve as a resource for information relative to all aspects of products and process quality
- Implement and enhance culture of Quality
- Final batch certification and release to the Israelian market
- Maintain the validity of the GMP license
- Ensure product safety and regulatory compliance
- Co-ordinate and host external inspections by External Authorities, third parties and Reckitt.
- QMS and Document Control
- Management Review
- Internal and External Audit
- Product Release
- Qualification of Suppliers
- Training to employees
- Deviation, Change Control, Customer Complaints
- BSc. in Pharmacy
- Valid Pharmacist License
- At least 2 years' experience as QP in the pharmaceutical industry
- Experience in developing and maintaining a robust QMS in a Pharma or Medical Device related industry
- Clear understanding and assessing upon product safety, quality, efficacy and compliance risks
- Good understanding of relevant requirements e.g.: EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211
- Strong interpersonal and communication skills
- Experienced Auditing, appropriate qualifications in auditing an advantage
- Language skills appropriate to the assigned country and/or regional cluster
- QP should be approved by the Ministry of Health via the importer license
Mploy