BIOTECHNOLOGICAL QUALITY INSPECTOR

Description

Position Summary: We are seeking a professional to ensure quality and regulatory compliance in manufacturing and warehouse processes, performing inspection, sampling, and documentation review. Key Responsibilities: 1. Quality assurance in pharmaceutical processes 2. Inspection and sampling of raw materials and products 3. Preparation and review of SOPs and documentation EDUCATION AND AREAS OF EXPERTISE Bachelor's Degree: B.Sc. in Pharmaceutical Chemistry, Industrial Pharmacy, Chemical Engineering, or related disciplines with pharmaceutical training PROFESSIONAL LICENSE REQUIRED Areas of expertise: · NOM-059-SSA1, NOM-072-SSA1, NOM-073-SSA1, NOM-176-SSA1, NOM-177-SSA1, NOM-220-SSA1 · SOP preparation · Sampling for Process Validation and Cleaning Validation · Sampling of Raw Materials and Packaging Materials · Good Manufacturing Practices (GMP) · Batch record review · In-process sampling and controls WORK EXPERIENCE Minimum 2 years in Inspection, preferably in the Injectable Products area Areas of experience: · Documentation · Inspection of raw materials and products · SOP preparation · Good Documentation Practices (GDP) · Quality assurance · Record review · Shipments Inspection and sampling in Aseptic Areas RESPONSIBILITIES Verify that Manufacturing and Warehouse areas carry out their processes using current documentation and logbooks Ensure availability of appropriate record forms for activities impacting product quality Perform inspection and sampling of raw materials and products, and compile reports promptly to support timely and proper release Analysis of packaging materials Prepare SOPs according to role, responsibilities, and applicable pharmaceutical regulations Review deviations or non-conformities Participate in product market withdrawal processes and corresponding simulations. Employment Type: Full-time Salary: $12,000.00 - $15,000.00 per month Benefits: * Company parking * Option for indefinite-term contract * Cafeteria service * Grocery vouchers Experience: * Quality control: 1 year (Preferred) Work Location: On-site employment