• Good knowledge about writing SOP, SMF, VMP, different validation protocols and other related documents
• Familiar with international GMP guidelines specially PIC/S
• Familiar with Pharmacopeia especially USPE
• Establishment of strong QA system in OSD manufacturing site.
• Validation and Qualification Management
• Coordinating inspection and audit arrangements
• Providing support in all areas of quality
• Identifying opportunities for improvement of quality processes
• Administering quality activities
• Identifying opportunities for improvement of regulatory processes
Requirements
• The ideal candidate will be an Pharm.D or MSc in Medical Sciences
• Minimum 4 year previous experience in Pharmaceutical Quality systems (You have worked in a quality or production department)
• Should be able to demonstrate the ability to work on your own initiative
• Good IT skills
• Good understanding of the relevant PIC\S , EU guidelines and Iranian and regulatory framework is required
• Good communication skills
• Time management and high attention to detail and accuracy
• Fluent in English