Quality Assurance Regulatory Specialist

Quality Assurance Regulatory Specialist

Job Description

• Development, periodic review, revision and implementation of SOPs and quality control unit instructions • Actively assists in investigations into product-quality failure or non-compliance. • Effectively manages priorities in order to implement corrective and preventive actions • Correctly applies CAPAs or change management. • Appropriately applies principles of continuous improvement. • Approves and ensures implementation of standardized operating procedures. • Approves documents according to templates and required GMPs. • Accurately assesses audit findings (production, control laboratory, packaging, labelling, etc.). • Provides inspectors with clear and comprehensive files (external audits). • Responds with proficiency to questions from inspectors (external and internal audits). • Actively engaged in the follow-up of audit observations. • Support all Regulatory Affairs activities in order to achieve and maintain registrations in compliance with all national and regional Regulatory and legal obligations. • Conducting inspections of distributors and wholesalers as necessary per GMP requirements • Acting as primary quality contact person with Third Party Logistics and as qualified person for internal quality compliance matters • Annual product reviews and review of stability reports for compliance with Food and Drug Regulations • Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals • Periodic GMP training for relevant staff • Timely approval of incoming batches, batch inspection and release according to SOPs • Analyze, monitor and ensure that the organization processes are comply with international standards • liaising with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations

Requirements

• Pharmacist (Pharm D.) • +3 years’ relevant experience in the regulated pharmaceutical industry, specifically including Quality Assurance, Quality Control, and/or Regulatory affairs • Experience with GMP inspections and third party audits • Understanding of pharmaceutical policies and rules • Solid computer skills, using MS Office • Fluency in English language especially in writing

About Company

10-49 employees

Tachra Darou is made by cross function of some different experiences of pharmaceutical field in Iran, including: importation, production, registration and Marketing. It was established on 2008 based on modern attitude to new private section in the Iranian pharmaceutical marketplace and designed as a small private company to fill the gap of professional and agile approach to international pharma field. Now, Tachra Darou with different international pharma partners consist of young & ambitious team works to shortlist, register , introduce and marketing of new medicines to Iranian medical society.

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