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İlan yayından kaldırılmıştır
İstanbul(Asya)(Ümraniye)
İş Yerinde
İş Yerinde
Job Type
Full-Time
Years of Experience
No experience preference
Department
Quality
Quality
Application Count
488 application
Job Type
Full-Time
Years of Experience
No experience preference
Application Count
488 application
Department
Quality
QUALIFICATIONS AND JOB DESCRIPTION
- University degree in pharmacy, biochemistry, chemistry, chemical engineerin
- Experience in the regulated industry preferably in Supplier Quality Assurance & Auditing area (pharmaceutical environment preferred) is required.
- Knowledge, practical application and understanding of the sciences/quality assurance are required to perform the functions of this position, including problem solving, troubleshooting, and follow-up skills used in a pharmaceutical/GMP environment
- Demonstrated ability to collaborate with others in cross-functional settings required.
- Demonstrated ability to communicate positively with personnel at all levels (verbally and in writing) is required.
- Demonstrated ability to take initiative and a willingness to learn and stay abreast of current standards required.
- Must have good personal computer skills. Experience using Microsoft Office software and SAP skills are preferred.
- Must be willing to travel extensively to perform job.
- Excellent command of both written and spoken English
Job Description
- To complete Supplier Qualification Process and keep updated for All Raw Materials, Packaging Materials, GMP Critical Service Providers and GMP Critical Auxiliary Materials which are planned to be used in local Contracted Manufacturers.
- Track supplier quality levels and report periodically; Issue audit reports and make recommendations for quality improvements to audited suppliers.
- To perform GMP Audits of Contracted Manufacturers, Packaging material/ Raw material Manufacturers/Suppliers, GMP Critical Service Providers and GMP Critical Auxiliary Material Manufacturers, follow up CAPAs and ensure completing on time.
- To enter information into the Approved Manufacturer Database and to keep updated. To perform annual performance evaluations of raw material, packaging material manufacturers/suppliers, GMP critical service providers and GMP critical auxiliary materials manufacturers
- To prepare quality assurance agreements for raw material & packaging material manufacturers, GMP critical service providers, GMP critical auxiliary material manufacturers and global Bayer sites and to keep them updated.
- To follow up changes of raw materials, packaging materials which are used in local CMOs, GMP critical service providers and GMP critical auxiliary materials. To compare specifications if needed, to provide supplier qualification documents and follow up trial samples and analysis results, to get in contact with global contacts when necessary and to define quality requirements.
- To get in contact with the manufacturers/suppliers regarding discrepancies of raw materials, packaging materials, GMP critical service providers and GMP critical auxiliary materials used in local CMOs and provide related CAPAs.
- In order to simplify workflow of the related department, evaluate the points that can be improved in scope of projects & To support global projects. To maintain the coordination of other departments in scope of local supplier management projects.
Preferred Candidate
Bachelor’s(Graduate)
English(Reading : Advanced, Writing : Advanced, Speaking : Advanced)
Kalite Denetçisi pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
Kalite Denetçisi Kalite Denetçisi Maaşları Kalite Denetçisi Nasıl Olunur? Kalite Denetçisi Nedir? Kalite Denetçisi İş İlanları
Kalite Denetçisi pozisyonu ile ilgili daha detaylı bilgi almak ya da diğer iş fırsatlarını incelemek için aşağıdaki sayfaları inceleyebilirsiniz.
Kalite Denetçisi Kalite Denetçisi Maaşları Kalite Denetçisi Nasıl Olunur? Kalite Denetçisi Nedir? Kalite Denetçisi İş İlanları