افق تولید دارو پارس

منتشر شده 4 سال پیش

Job Description

Detailed list of responsibilities is presented below 1. Before certifying a batch prior to release the QP doing so should ensure, with reference to the guidance above, that at least the following requirements have been met: a. The batch and its manufacture comply with the provisions of the marketing authorization (including the authorization required for the importation where relevant). b. Manufacture has been carried out in accordance with Good Manufacturing Practice or, in the case of a batch imported from a third country, in accordance with good manufacturing practice standards at least equivalent to EU GMP. c. The principal manufacturing and testing processes have been validated, account has been taken of the actual production conditions and manufacturing records. d. Any deviations or planned changes in production or quality control have been authorized by the persons responsible in accordance with a defined system, as well as by the QP Any changes requiring variation to the marketing or manufacturing authorization have been notified to and authorized by the relevant authority. e. All the necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations or planned changes. f. All the necessary production and quality control documentation has been completed and endorsed by the staff authorized to do so. g. All audits have been carried out as required by the quality assurance system. h. The QP should in addition consider any other factors of which he is aware which are relevant to the quality of the batch. 2. The QP should maintain his knowledge and experience up to date in technical and scientific progress and changes in quality management and applicable GMPs relevant to the products which he is required to certify. 3. If the QP is called upon to certify a batch of a product type with which he is unfamiliar, for example because the manufacturer for whom he works introduces a new product range or because he starts to work for a different manufacturer, he should first ensure that he has gained the relevant knowledge and experience necessary to fulfill this duty. In accordance with national requirements the QP may be required to notify the authorities of such a change and may be subject to renewed authorization. 4. Batch Release of the finished dosage forms 5. Sign the QP declarations for the API manufacturers as required for an EU registration application based on executed audits or based on audit reports by third parties provided that the QP is satisfied with the audit report 6. Review and sign Technical agreements as well as Quality agreements between Development and collaborators 7. Release product as per Annex 16 of Eudralex vol IV and national regulation 8. To participate review and reporting of quality defect 9. To participate in complaints investigation 10. To coordinate product recalls 11. To participate in supplier or vendor audits, qualification and approval 12. To participate in self-inspections. 13. To participate and approval in technology transfers 14. Reviewing and approval of Technical Agreements 15. Participate in supplier or vendor audits, qualification and approval 16. The authorization of written procedures and other documents, including amendments. 17. Plant hygiene. 18. Common responsibility in Qualification and Process validation status. 19. The approval and monitoring of contract manufacturers and providers of the other GMP related outsourced activities. 20. Common responsibility in the designation and monitoring of storage conditions for materials and products. 21. The retention of relevant records. 22. The monitoring of compliance with the requirements of Good Manufacturing Practice. 23. The inspection, investigation, and taking of samples, to monitor factors which may affect product quality. 24. Capital investment and project recommendations, assessments and reviews for all quality relevant matters. 25. To ensure an effective pharmaceutical quality system is in place to achieve the quality objectives, and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the company 26. To participate in the design, implementation, monitoring, maintenance and advocate continual improvement of an effective pharmaceutical quality system 27. To demonstrate strong and visible support for the pharmaceutical quality system and ensure its implementation throughout their organization 28. Participate in establishment of a quality policy that describes the overall intentions and direction of the company related to quality should determine 29. Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management 30. Participation in management reviews of process performance, product quality and of the quality management system and advocating continual improvement 31. Collaborate with Senior Manager for Quality, Senior Manager of Operations, as well as, when necessary, with QC Laboratory Manager and Production manager on daily basis 32. Any other duties assigned by the CEO related to the scope of QP role and duties in pharmaceutical industry

Requirements

1. Work experience – minimum 4 years at QA or QC management positions, minimum 7 years of overall experience in pharmaceutical production company. Experience in pharmaceutical production is an advance. 2. Education – pharmacy, technology, chemistry 3. Technology skills (IT Skills) • Microsoft Office package (Word, Excel, Power Point) 4. Key skills • Confidence • Excellent technical skills • Good numerical skills and an understanding of statistics • Attention to details • Leadership skills • Planning and organization skills • Communication and interpersonal skills • Problem-solving skills • Team working skills • IT skills • Must also be able to handle responsibility and the pressure of meeting deadlines. 5. Language skills • Farsi, English (fluent reading, writing, speaking) 6. Certificates and honors • Master degree or specialization in pharmaceutical Quality Control or Quality Assurance and/or certificates and knowledge about QMS standards in pharmaceuticals is an advance • Adequate trainings and certificates/licenses in the scope of QP role and duties 7. Personal Comments Shift and 'on-call' work may be required, particularly where manufacturing/production equipment is in continual 24-hour operation. 8. Reporting to: CEO

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Seniority

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