Local Manufacturing Supervisor

Job Description

KEY ACCOUNTABILITIES:

Your Responsibilities Include, But Are Not Limited To:

• Being present in contract manufacturing companies during manufacturing periods for coordination and supervision of under-license manufacturing and establishing good working relationships (currently approx. 5 days/month travel in Iran).
• Ensuring the implementation of GXP and Quality Assurance principles during manufacturing operations and in accordance with the Quality Agreement.
• Participating in the documentation of batch records and any quality events.
• Ensuring that the Regulatory & QA Manager is kept informed of all critical and major issues that may have an adverse effect on the quality of the product.
• Collaborating with the Regulatory & QA Manager in providing direction and support to contract manufacturing companies and to ensure that they are qualified, achieve a high level of competence, and are motivated to carry out their duties to ensure that the products meet Rougine Darou and Licensor quality, efficacy, and safety requirements.
• Accompanying the team in contract manufacturing sites and suppliers during audits, continuous improvement activities, or to resolve any issues.
• Providing input and reports to regulatory, commercial/sales, and financial departments on manufacturing status and amounts.
• Assisting in setting up and improving Pharmaceutical Quality Management System in Technology Transfer and Local Manufacturing QA.
• Reporting to the Regulatory Affairs & QA Manager.

Requirements:

• Bachelor's or Master's degree in Biochemistry, Chemistry, or other related fields.
• At least 5 years of experience in manufacturing in the pharmaceutical industry (preferably in technology transfer and under-license manufacturing).
• Familiar with GXP principles.
• Familiar with quality assurance in the pharmaceutical industry.
• Familiar with the related local and international rules and regulations (Iran’s Food and Drug Administration, FDA, EU, ICH, etc.).
• Familiar with technical documents in the pharmaceutical industry (CTD, CPP, COA, Proforma Invoices, etc.).
• Familiar with principles of project management.
• Good communication, negotiation, and analytical skills.
• Result-oriented, hardworking, motivated, team worker, and problem solver.
• Average knowledge of Microsoft Office.
• Working knowledge of English.