Senior Quality Assurance Associate

Abbott

• University degree preferably in Chemical Engineering, Chemistry or Pharmacy
• At least 4 to 6 years of experience in pharmaceutical industry with specialization in quality control, quality assurance or analytical development 
• Thorough knowledge of cGMP quality regulations and compliance regulations and cGLP
• Good knowledge of analytical method validation, analytical method transfer, stability  and stability data evaluations, change control, exceptions, deviations, artwork development and review and control in pharmaceutical industry
• Good experience of supplier evaluation and qualification process and audit management and management of supplier complaints and follow up their CAPAs
• Strong analytical thinking, problem solving and negotiation skills 
• A good team player with strong communication capabilities
• Excellent verbal and written skills in EnglishComputer proficiency in
• Proficient computer skills
• Ability to travel 

İŞ TANIMI

• Reviewing and approving validation batch manufacturing protocols, stability protocols and stability reports, test method validation, transfer protocols and reports
• Preparing annual supplier audit schedule, monitoring and auditing suppliers
• Reviewing and approving change controls, exceptions, deviations and CAPA’s
• Taking related actions to prevent the occurrence of any non-conformances relating to product, process and quality systems
• Managing documentation system
• Maintaining systems to ensure compliance to company policies, cGMP, cGWP and local regulations