QA Compliance&Systems Specialist

Your role Abrimos vacante temporal para dar soporte al departamento de QA Compliance&Systems QA Compliance and Systems Specialist 1)Gives support for assuring the proper management and implementation of the Systems Master in the plant to be in compliance with the product requirements: ·Responsible of maintaining and approving QA relevant data for raw materials, packaging materials, bulk, semi-finished and finished products in SAP system of Siegfried El Masnou plant. ·Masters of production formulations: Develops, supervises and coordinates the creation and flow of the different manufacturing phases: bulk, filling and packaging (BOM’s). ·QA approver of product specifications for raw materials, materials and products in Labware System. ·To request and approve change control related to Labware product specifications and item codes. ·To review and approve FUST protocols in Labware System. ·Ensures that all specifications are in accordance with the product requirements. ·Responsible for the current and historical Masters archive. 2)Give support to QA Oversight in qualifications of new equipments and re-qualifications: ·To review and approve documentation related to the qualification/ re-qualification activities (HLRA, URS, protocols, reports and SOPs). ·Quality Responsible of deviations related to equipments. ·Quality Responsible of change control related to equipments. ·To review and approve CCDs of equipment performance checks in Labware System. 3)Review and approval of the documentation associated with qualification/validation carried out by Automation, Engineering, Validation and IT, in order to ensure that they comply with applicable regulations, local procedures and global requirements 4)Review and approval of periodic requalification, periodic reviews and re-evaluation of the systems and equipment 5)Gives support to the Management of Risk Management and Change Control 6)Review and approval of the documentation associated with Deviations, CAPAs management and Change Controls, where appropriate. 7)Review and approval of new versions of global policies related to Engineering/Validation department. 8)Assures the continuous review and update of procedures applicable to her activities Your profile ·Education: University degree in Pharmacy, Engineering, Chemistry or Microbiology. ·Languages: Fluent English and Spanish Working at Siegfried Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs. Who we are In the Midst of People’s Lives – Across the GlobeThe Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products. What we do in El MasnouBulk manufacturing and packaging of sterile ophthalmic products including eye drops, eye ointments, otic / nasal sprays