PbIn a few words /b /ppbr/ppbPosition: /b QA Technician Intern (Systems) /ppbLocation: /bLeón /ppbExperience: /b1 year /ppbr/ppbWant to know more? /b /ppINSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and experience in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health. /ppbr/ppThe activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialized RD centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development. /ppbr/ppbReady to be a #Challenger? /b /ppWhat are we looking for? /ppWe are recruiting a new INSUDER as an technician intern to join the QA team at our site based in León. /ppbr/ppbSpecific Responsibilities /b /pp• Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case. /pp• Review and approved internal SOPs /pp• Document management, distribution of authorized copies and removal of obsolete copies. /pp• Manage Change Controls, CAPAs and complaints. /pp• Manage discrepancies, root cause analysis, management layers and trend analysis. /pp• Provide initial GMP training program compliance. /pp• Validation activities related to manufacturing and cleaning processes /pp• Participate in the approval and certification of suppliers, auditing suppliers of raw materials and material conditioning. /pp• Develop the APR of different products on schedule. /pp• Do, review, monitoring the microbiological on equipment, environment of the site and purified water, trend analysis. /pp• Review and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site. /pp• Conducting of internal audits and participation in external. /pp• Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system. /pp• Review and coordinate with Production and Engineering/Maintenance the qualification of equipment and systems for complying with GMPs. /pp• Management of the quality technical agreements between the company and the customers. /pp• Management of suppliers and third parties. Support to Customer requests based on QTA, MA and/or Quality issues. /pp• Support to the qualified person /pp• Support on quality investigations and recalls. /pp• Management of GMP documentations and related archive /ppbr/ppbRequirements and personal skills /b /pp• Education: Degree in Pharmacy or Chemistry or Sciences. /pp• Languages: Intermediate or high level of English and bilingual in Spanish. /pp• Experience (years/area): A minimum of 1 year experience in similar position for a junior position. /pp• Specific Knowledge: Knowledge of quality systems (procedures, training, deviations/non-conformities, complaints, audits support, etc.) in production plants. /pp• Travels: Not required. /pp• Personal skills: Good communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills and persistent. /ppbr/ppbOur benefits! /b /pp Internship contract. /pp Attractive salary package. /p