Descripción de la oferta
Global Responsibility Assure 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. Specific Responsibilities · 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. · Review and approved internal SOPs · Management of GMP documentations and related archive. · Register, follow up and closing of CAPAs opened in the site. · Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system. · Management of GMP documentations and related archive. · Support to the qualified person. · Elaborate and follow-up self-inspections program and conduct self-inspections. · Support to Customers and Authorities request for quality and technical issues. · Elaborate and follow-up training annual program. · Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system. · Collaborate with supplier’s qualification management. · PQR preparation according to timelines included in the annual plan, internal procedures and TA in force. · Collaborate with Change Control management . Support to quality activities according to the appropriate training. . Validation activities related to manufacturing and cleaning processes . Review and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site. . Support the qualification of equipments and systems for complying with GMPs. Requirements and personal skills · Education: Degree in Pharmacy or Chemistry or Sciences. · Languages: Intermediate or high level of English required and bilingual in Spanish. · Experience (years/area): A minimum of 3 years’ experience in similar position. · Specific Knowledge: Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audits support, validations, change controls, etc.) in pharmaceutical companies.
