Quality Assurance Expert

Salamat Sazan Arad Daroo Tehran

Posted 2 years ago

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Job Description

● Review and approve all SOPs and protocols before finalization. ● Review and approve master BMR, BPR, and BCR content. ● Conduct and ensure proper document control procedures. ● Ensure proper and efficient training practices for all GMP-related personnel. ● Establish an appropriate QMS system and ensure proper QMS practices as per SOPs (NOE, deviation, CAPA, investigation, OOS, and OOT). ● Ensure proper investigation and follow-up of regulatory-related issues such as complaint, return, and recall. ● Conduct correct training programs. ● Establish QRM in the facility. ● Quality policy and manual preparation/review. ● VMP and SMF preparation/review/approval. ● Ensure correct and effective in-process quality assurance. ● Plan and conduct self-inspections and equipment qualification activities. ● Conduct and ensure effective validation and PQR activities. ● Ensure reliable outsourcing activities. ● Collaborate in artwork preparation. ● Ensure GMP in production and packaging, GSP and GDP in facilities. ● Conduct GMP audits by regulatory bodies. ● Ensure GXP issues in contract manufacturing. ● Implement all instructions issued by the Iran FDA regarding the production and distribution of medicine, collecting items, and submitting reports to the Iran Food and Drug Administration. ● Control of batch Records of each batch of pharmaceutical products in order to include all product information and quality control results and its compliance with CTD.

Requirements

● Bachelor's or Master's degree in Pharmaceutical, Medical, or Paramedical Sciences. ● At least 2 years of experience in pharmaceutical jobs. ● Familiar with GXP principles and technical documents e.g.; CTD, CPP, COA, Proforma, Invoice, GMP certificate, DIAF, etc. ● Familiar with regulations, rules, instructions, and policies of the Food and Drug Administration of Iran, the registration process and Iran Drug List, TTAC, IRC, and quotation and planning systems. ● Familiar with quality assurance and international regulation e.g.; FDA, EU, etc. ● Sense of human relations, capability to work in a team, Independence, and initiative. ● Task orientation, technical knowledge, hardworking, and integrity. ● Ability to undertake multiple tasks at the same time without losing focus. ● Self-motivated individual with effective organizational skills. ● Must be proactive, with the ability to meet and surpass project deadlines. ● Good knowledge of Microsoft Office, especially Outlook. ● Communication and negotiation skills. ● Time and stress management skills. ● Good command of English. ● Reliable, trustworthy, and good-tempered.

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