Country Spain
City El Masnou
Functional Area Siegfried Group
Job Group Support Function
Employment Type Defined contract (Siegfried)
Defined Contract Period 1 year
Working time Full-time
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
- Comprehensive Product Management: Oversee the entire commercial lifecycle of the product, from its transfer by development to the present date, acting as the Single Point of Contact (SPOC).
- Risk Analysis and Quality Control: Create, update, and monitor the product-specific Quality Risk Analysis (QRA) and ensure compliance with quality standards.
- Data Monitoring and Analysis: Evaluate critical and key variables through statistical analysis, track data trends, and review the Annual Product Quality Review (APQR) to make informed decisions regarding control status.
- Inspection Readiness: Ensure all aspects related to the product process are prepared for audits and regulatory inspections.
- Performance Monitoring and Improvement: Identify trends, detect issues, and lead the implementation of corrective and preventive actions (CAPAs) to enhance products.
- Deviation Management and Improvement Projects: Investigate process deviations, lead optimization projects, and engage cross-functional teams in improvement initiatives.
- In-Process Controls (IPC) Monitoring: Ensure the tracking of critical parameters in laboratories and guarantee that data is visible and communicated at the plant level.
- Technical Change Assessment: Analyze the impact of process modifications, determine their feasibility, and manage the quotations associated with these changes.
- Process and Product Validation: Ensure continuous validation status, alignment with the APQR, and implementation of control strategies based on Critical Quality Attributes (CQA), Critical Process Parameters (CPP), and Critical Material Attributes (CMA).
- Product Launch and Transfer: Facilitate product transfers by ensuring technical documentation and providing necessary support to the receiving plant.
- Manufacturing Optimization and Excellence: Lead improvement projects to enhance the robustness and sustainability of pharmaceutical processes in collaboration with Operational Excellence (OPEX).
Your profile
Minimum 5 year experience in process support, e.g. Process Expert
role on the shop floor of pharmaceutical manufacturing, QA/QC or Validation.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Sound experience of data handling and applied statistics is a must
Operational Excellence Mindset and experience is a plus.
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