Responsible Pharmacist Novo Nordisk Pars

  • Full Time

  • Tehran

      -   Kordan, Karaj

Responsible Pharmacist

Posted Long ago

Job Description

•Main Objective: As a Responsible Pharmacist, you will be responsible for ensuring that a particular batch has been manufactured in accordance with its marketing authorization, EU Good Manufacturing Practice (GMP) and local requirements. •Main responsibilities: -Ensure that QA Manager and Factory Management is informed about non-conformities that tentatively might be classified as major or potential recalls -Participate in the planning, carrying out and following up of inspections, audits and internal inspections within field of responsibility -Authorized to delegate certification and release of batches of medicinal products to QP delegates in the department -Participate in audit of Novo Nordisk contract manufacturer or delegate to QP delegates -Participate in quality review meetings at CMO’s or delegate to QP delegates -Quality assurance in relation to establishment, approval and monitoring of contract manufacturers world wide -Ensure license to operate, GMP compliance and audit/inspection performance at contract manufacturers -Appointing and approve QP delegates in Local Manufacturing Tehran -Establish and maintain list of QP delegates within Local Manufacturing Tehran -Review and approve job description of QP delegates in Local Manufacturing Tehran -Approving QP delegates access to IT release systems -Review and approve procedures for batch status assignment (Confirmation and certification) -Review and approve Novo Nordisk APR report -Once a year, randomly check certification for release carried out by QP delegate, and the certification/release process

Requirements

-Have a Pharmacist Academic degree, according to IFDA requirements, with significant experience in a Pharmaceutical manufacturing and/or manufacturing Pharmaceutical products in a GMP environment -Have in-depth knowledge of pharmaceutical quality and regulatory requirements -The ideal candidate will need an open mindset who can work independently and as a team player with a strong focus on results to succeed in this role -Further to this, you should have good communication skills with the ability to establish good relationship with local and global team. You must be fluent in English, both written and oral -Ideal Age Range: 30 - 50

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