PHARMACEUTICAL CHEMIST / TECHNICAL DIRECTOR

Description

Position Summary: We are seeking a licensed Pharmaceutical Chemist / Technical Director with experience in quality management, pharmacovigilance, and inspection controls for pharmaceutical products. Key Highlights: 1. Technical Director role with key responsibilities 2. Experience in quality management and pharmacovigilance 3. Quality supervision and regulatory compliance **PHARMACEUTICAL CHEMIST / TECHNICAL DIRECTOR** **REQUIREMENTS**: * Licensed Pharmaceutical Chemist, authorized in the Department of Lima; pharmacy license available. * More than 5 years of experience as a Technical Director. * Minimum intermediate level of English, both spoken and written. * Experience in Quality Management for pharmaceutical establishments, specialty pharmaceutical products, medical devices, and sanitary products. * Experience in Pharmacovigilance Management for specialty pharmaceutical products. * Knowledge of Good Storage Practices, Good Distribution and Transportation Practices, and Good Pharmacovigilance Practices. * Experience in inspection controls for pharmaceutical products, natural health products, medical devices, and sanitary products. * Experience in preparing and reviewing bidding documents. * Knowledge of importing pharmaceutical products, medical devices, and sanitary products. * Experience in pharmaceutical audits of finished pharmaceutical product warehouses, packaging materials warehouses, and raw material warehouses. **RESPONSIBILITIES**: * Assign quality supervisors to ensure compliance with warehouse-related activities. * Coordinate with the regulatory team to submit documentation related to minor or major product changes. * Assign the quality team to schedule self-inspections for the company's own warehouse and subcontracted warehouses. * Assign the pharmacovigilance team to prepare Individual Case Safety Reports (ICSRs), Periodic Safety Update Reports (PSURs), and other required communications to the regulatory authority (DIGEMID), as well as training for all pharmacy staff. * Conduct inspection controls on finished products entering warehouses via importation or local purchase. * Monitor cleanliness of warehouse areas. * Monitor storage temperatures in warehouses: products stored below 30°C and under refrigerated conditions. Verify thermal mapping of the warehouse, temperature monitoring using thermohygrometers, and daily recording of temperature and humidity. * Verify that warehouse personnel are adequately trained, properly dressed, and fit for operations inside and outside the warehouse. * Verify absence of temperature fluctuations in refrigerated or frozen product warehouses. * Verify equipment qualification and process validation for conditioning products in thermal boxes. * Receive complaints and claims from third parties regarding pharmaceutical products, medical devices, and sanitary products. * Verify that product recalls are conducted in accordance with the Good Storage Practices Manual and Good Distribution and Transportation Practices Manual. * Verify that transport units (for dispatch or procurement) are fit for operation. * Verify that safety credentials are valid for all pharmacy staff. * Other duties mandated by the Ministry of Health. BENEFITS * Formal employment registration from day one. * General employment regime. * All statutory benefits. * ESSALUD insurance, SCTR insurance, and Life Insurance Law coverage. * Pleasant work environment. Employment Type: Full-time Salary: Starting from S/.3,000.00 per month Work Location: On-site employment