Quality Operations Specialist

Gensenta İlaç Sanayi ve Ticaret Anonim Şirketi

Job Description:

• Oversight of production activities to ensure that production processes are performed in compliance with GMP rules.
• Manage and follow-up of deviation investigations by contributing the root cause analysis, giving QA decision and follow-up the corrective & preventive actions.
• Communicate with foreign companies from quality aspect as contact person.
• Perform batch disposition and release.
• Deliver training to employees to refresh or improve their knowledge on GMP, GDP and the other SOPs in quality system.
• Perform QA review and approval of master batch records.
• Approve GxP critical changes and Bill of Material forms in the SAP system.
• Manage and participate risk assessments studies as quality contact person.
• Review and approve the technical documents relevant to production area and equipment.

General Qualifications:

• Bachelor's Degree in Chemical Engineering, Chemistry, Bioengineering or Pharmacy departments,
• At least 2 years of experience in aseptic manufacturing processes of the  pharmaceutical industry,
• Good or excellent command of English both written and spoken,
• Comprehensive knowledge of GMP guidelines,
• To be highly motivated with strong written, communication and presentation skills,
• Result-oriented and successful in time management,
• Analytical thinking and problem-solving skills,
• Proficiency in Microsoft Office tools, QMex and SAP programs,
• Completion of military service for male candidates.