ppAssure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs management, support on PQRs, Change Controls, cleaning and process validations, among other tasks of the area. Site services compliance in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU US GMP compliance. /p h3Specific Responsibilities /h3 ul liDevelop 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. /li liReview and approved internal SOPs /li liManagement of GMP documentations and related archive. /li liRegister, follow up and closing of CAPAs opened in the site. /li liSupport external audits and inspections according to the Annual Plan to assess the quality of the GMP system. /li liSupport to the qualified person. /li liElaborate and follow-up self-inspections program and conduct self-inspections. /li liSupport to Customers and Authorities request for quality and technical issues. /li liElaborate and follow-up training annual program.



/li liCollaborate with supplier’s qualification management. /li liPQR preparation according to timelines included in the annual plan, internal procedures and TA in force. /li liCollaborate with Change Control management /li liSupport to quality activities according to the appropriate training. /li liValidation activities related to manufacturing and cleaning processes /li liReview and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site. /li liSupport the qualification of equipments and systems for complying with GMPs. /li /ul h3Requirements and personal skills /h3 ul liEducation: Degree in Pharmacy or Chemistry or Sciences. /li liLanguages: Intermediate or high level of English required and bilingual in Spanish. /li liExperience (years/area): A minimum of 3 years’ experience in similar position. /li liSpecific Knowledge: Knowledge of EU US GMPs, quality systems (CAPAs, PQRs, audits support, validations, change controls, etc.) in pharmaceutical companies. /li /ul /p #J-18808-Ljbffr

📌 Técnico QA (PQRs & CCs) (León)
🏢 Chemo
📍 León