At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
Buscamos QA Compliance Specialist para cubrir una baja temporal.
As appropriate:
- Manage the activities of QA oversight for Engineering, Automation, Validation and IT.
- Manage the activities of Change Control, Risk Assessment and Computerized System Validation (CSV).
- Manage the activities of QA oversight for Data Integrity (DI) in order to maintain and increase DI culture at the site.
- Ensure the continuous maintenance and update of the Quality Management System, managing and implementing EU and FDA regulations, ISO standards, internal and external applicable regulations.
- Lead Internal Audit Plan and/or take part of the Internal Auditor Team of the site.
QA oversight:
- Maintain an effective support and oversight for IT, Automation, Engineering and Validation activities related to Quality Systems processes (not wise-batch related), ensuring compliance with the applicable regulations, local and global procedures.
- Review and approve (re)qualification and periodic review of processes, systems and equipment.
- Ensure effective QA oversight for New or Program Projects as a Project Team Member. For instance, but not limited: review and approve documentation related to process validation, deviations, change control,…
- Ensure QA oversight of Pest Control.
Your profile
- Education: University Degree in Sciences
- Languages: Fluent in English and Spanish (Catalan desirable).
- Experience: 1 to 5 years of progressive experience in Quality Assurance and/or in sterile manufacturing facility within a pharmaceutical industry. Familiarity will quality issues and production processes (GMP, GLP, FDA, ISO).
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 Globe
The 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 Masnou
Bulk manufacturing and packaging of sterile ophthalmic products including eye drops, eye ointments, otic / nasal sprays
📌 QA Compliance Specialist
🏢 Siegfried
📍 El Masnou