The main scope of the role is to develop, implement and review quality system documentation.
- Management of Regulatory compliance
- Support and maintenance of related Key Performance Indicators
- Achieving, controlling and maintaining consistent quality of products
- Managing customer complaints; investigate Root Causes and establish /implement CAPA (Corrective actions/Preventive actions)
- Support internal audit of the quality system, ensure implementation of preventive & corrective actions
- Gather data for Product Quality Review and summarize as per business process
- Monitor and escalate deviations, out of specifications (OOS), CAPA and Change Control management
- Organize and maintain various databases
- Deal with requests from other departments
Education and Experience:
- University degree in Chemistry, Pharmacy or Microbiology University
- Good interpersonal skills, ability to work with all levels of personnel and management
- Good problem solving and risk assessment abilities
- Good organizational and in time management skills
- Analytical thinking, attention to detail, communication skills, proactivity, result orientation
- Proven flexibility and ability to deal with multiple and changing priorities
- English fluent in speaking and writing
- Knowledge about Microsoft office word and excel is a must and ability to learn and become proficient with appropriate software
- Minimum 3 years experience on Quality Unit in Pharma Industry
- ERP system experince (e.g. Trackwise, Glorya etc)
- GMP Guidelines knowledge
Manufacturing Quality Assurance
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