QA – RA Manager Türkiye – Responsible Pharmacist

Required Qualifications

• Strong analytical thinking, planning ability, solution-oriented mindset; team player with strong communication skills
• Graduated from the Faculty of Pharmacy
• Minimum 2 years of experience in production sites in production, quality assurance, or quality control
• Good command of English
• Proficient in MS Office programs
• Knowledgeable about quality systems
• Preferably has knowledge of supply chain processes

Duties and Responsibilities

• Acts as the authorized/responsible person of the Production Site before the Ministry of Health. Ensures compliance with the Ministry of Health requirements. Ensures that products are secondary packaged and stored in accordance with the Human Medicinal Products Manufacturing Plants Regulation, Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP), and ensures that records are kept for the required periods and submitted to authorities upon request.
• Ensures that all tasks assigned in the warehouses are completed in line with the company’s quality management system principles, SOPs/Instructions, and Occupational Health & Safety and Environmental guidelines.
• Fulfills assigned responsibilities in compliance with company strategies and in alignment with GMP, GDP, and the quality management system.
• Responsible for establishing and maintaining quality systems.
• Represents the production site during Ministry of Health and customer GMP/GDP inspections.
• Ensures the execution of internal audits, documentation of corrective actions, and requests external audits when necessary.
• Ensures the planning, implementation, and development of the Quality Assurance System.
• Ensures the preparation, approval, training, and distribution of QA system documentation.
• Ensures periodic management review of the quality system and implementation of corrective/preventive actions to address weaknesses.
• Supports supplier audits and verifies that suppliers are approved and critical processes impacting products are secured by contracts.
• Investigates customer complaints and evaluates potential impacts on products.
• Ensures recall activities including retrieval, control, storage in segregated areas, and proper documentation of recalled products.
• Conducts recall tests within defined timeframes and maintains records.
• Ensures systematic evaluation and documentation of any changes that may affect product quality.
• Ensures deviations are initiated within defined timelines, thoroughly assessed, and that corrective/preventive actions are implemented.
• Ensures proper documentation and retention of production site and quality-related documents.
• Supports projects and activities that may impact product and material quality.
• Ensures that products and materials are stored within validated temperature limits and in clean, safe environments.
• Ensures warehouse and work areas are maintained in an orderly and well-kept condition.
• Ensures cleaning and pest control operations are carried out regularly and effectively.
• Ensures maintenance and calibration of warehouse equipment and infrastructure are performed according to the annual plan.
• Ensures planning, execution, evaluation, and documentation of trainings (GMP, GDP, SOP, etc.).
• Prepares and updates SOPs related to their role.
• Ensures all warehouse-related documentation is maintained and stored in compliance with requirements.