Kalite Uyum Müdürü İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Jenerik dünyaya inovasyon katan Türkiye’nin genç, dinamik, yenilikçi ve başarı odaklı sağlık şirketi;GENVEON Gebze Plastikçiler Organize Sanayi bölgesinde yer alan İlaç Üretim Tesisimizde görevlendirilmek üzere Kalite Uyum Müdürü arıyor!
İŞ TANIMI;
- Provide QA oversight, technical expertise, and leadership across all aspects of product manufacturing from raw materials, through warehouse activities, engineering, quality control, manufacturing, and operations.
- Deviation handling experience for production and quality control.
- Product release experience.
- Ensure regulatory compliance for released products.
- Manage Product Quality Review and Change Control processes for site.
- Manage inspections of Ministry of Health, Customer, ISO 9001 and self-inspection. Perform self-assessments, manage inspection readiness activities, and lead/support audits and inspection. Response to findings, organize CAPA plan and follow up to close accurately on time.
- Broad knowledge and understanding of GMP and relevant pharmaceutical regulations in Europe and relevant markets such as Brazil, Russia, Canada, CIS, etc. and global/local Quality Regulatory concepts and requirements (ICH, EUGMP, Annex 1, Compendia, etc.).
- Perform Supplier Qualification activities for API, excipient, packaging materials and service providers such as periodic review, Audit, Quality Agreements and risk management. (Supplier audit experience and auditor certificate are plus.)
- Maintain the Approved Vendor List, manage the approval process for CEP/DMF update for APIs to be used in products.
- Coordinate the compliant, deviation and CAPAs regarding to suppliers and cooperate with Purchasing Department.
- Initiate and lead escalation process in case of any failure has impact on product on market to the global quality level in order to take necessary market actions.
- Preparation of Site Quality Risk Assessment and create Site Quality Plan including annual data integrity plan.
- Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls). Review and coordinate approval of all changes made to the manufacturing, testing and control processes.
- Thorough understanding and application of 21 CFR Part 11, Annex 11, ICH, MHRA and WHO Guidances on DI.
- Annual GxP training to all site personnel including 3rd parties.
- Establish Quality Culture and awareness.
İŞ ŞARTLARI İLE İLGİLİ ÖZEL NİTELİKLER:
- Advanced level of English
- SAP, QMEX and MES experience and to be competent with most Microsoft Office Program.
- Having a good level of Quality mindset. (Having global company experience is a plus)
- Work and decide under pressure and ambiguity
- Effective time management
- Adapt well changes in workplace
- Understanding of priorities, objectives, and project timelines
- Having minimum 5 years experience as manager in Pharmaceutical Industry
- Bachelor’s degree in chemistry, pharmacy or related departments
