مدیر امور رگولاتوری | Regulatory Affairs Manager

استانداردهای تضمین کیفیت را تفسیر و پیاده سازی کنید. ارزیابی کفایت استانداردهای تضمین کیفیت اقدامات اصلاحی. پیروی مداوم با کیفیت و الزامات نظارتی صنعت با قوانین و الزامات دارویی در شرکتهای دارویی. در امور نظارتی سازمان غذا و دارو ، تهیه اسناد و پرونده ها برای ارسال/ثبت نام به وزارت بهداشت. مستندری سیستم های شارژون و TTAC برای ثبت محصولات دارویی ، مکمل ها و مواد اولیه را تهیه می کند. شرکت. مهارتهای حل و فصل. مهارت های حل کننده مهارت.

• Interpret and implement quality assurance standards.
• Evaluate the adequacy of quality assurance standards.
• Document internal audits and other quality assurance activities.
• Investigate customer complaints and non-conformance issues.
• Develop, recommend, and monitor corrective and preventive actions.
• Identify training needs and organize training interventions to meet quality standards.
• Coordinate and support on-site audits conducted by external providers.
• Evaluate audit findings (internal or external audits) and implement appropriate corrective actions.
• Assure ongoing compliance with quality and industry regulatory requirements.
• Analyze records of product returns to identify specific problems or trends over time.
• Prepare documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, and corrective actions.
• Prepare all quality department SOPs.
• Ensure that manufacturing processes comply with GMP standards at both national and international levels.

Requirements:

• Familiar with the laws and requirements of pharmacovigilance in pharmaceutical companies.
• Proficient in the regulatory affairs of the Food and Drug Organization, preparing documents and files to send/register to the Ministry of Health.
• Mastery of the Chargoon and TTAC systems for registering pharmaceutical products, supplements, and raw materials.
• Proficiency in English
• Doctor of Pharmacy.
• At least 4 years of experience as a quality assurance manager in a pharmaceutical manufacturing company.
• Leadership skills.
• Problem-solving skills.
• Communications and interpersonal skills.
• Attention to detail.
• Analytical thinking.
• Maturity.
• Result oriented.
• Excellent documentation skills.
• Fluent in English.
• Excellent MS Office knowledge (Excel, Word, PowerPoint).
• Good numerical skills and an understanding of statistics.
• Familiar with local regulatory affairs and EU GMP standards.
• Frequent traveling availability.