General Information

Country United States

City Irvine, California

Functional Area Operations

Job Group Quality Assurance

Employment Type Permanent Contract

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

Responsibilities
  • Ensure cGMP compliance of computerized systems mainly locally at the Irvine Site.
  • Supporting validation of global systems at Irvine Site.
  • Ensure compliance with the Siegfried Ltd Quality Policy, cGMP rules and ISO 9001 standard and their enforcement in the area of responsibility.
  • Group-wide support for the implementation and maintenance of the multi-site SOP D PO 00-0028 "Computerized System Validation"
  • Group-wide support to achieve or maintain "Data Integrity".


Required Knowledge, Skills and Abilities
  • Assesses the need for qualification/validation of computerized systems, together with the responsible parties, according to cGMP rules, including 21 CFU Part 11 and EU GMP Annex 11.
  • Leads, coordinates and collaborates in the necessary qualifications/validations for Computerized Systems.
  • Assesses and approves changes to computerized systems related to CSV.
  • Records, registers, assesses and tracks internal complaints and deviations for computerized systems related to CSV until their final approval.
  • Verifies that corrective actions agreed upon during validations/qualifications in the task area have been implement.
  • Assists system owners in conducting periodic CSV reviews of their computerized systems.
  • Supports the responsible persons during external and internal audits (FDA, customers, etc.)
  • Supports the maintenance of necessary CSV default documents (POs, SVs, AAs, Bes, and guided templates).
  • Maintains the CSV inventories and the system documentation (overview documentation).
  • Trains and supports other Siegfried employees, as necessary, regarding CSV
  • Acts in accordance with the Siegfried Ltd Quality Mission Statement, cGMP rules and ISO 9001 standard and enforces their application in his/her area of responsibility.
  • Follows all standard procedures related to his/her work and enforces them in his/her work area.
  • Keeps informed about new guidelines, standards and regulatory requirements in the field of CSV and in turn informs all affected departments within Siegfried Ltd about these changes and also requests changes to internal regulations that become necessary as a result of such changes.
  • Informs the superior about the status of the work, in particular about process and, in case, difficulties encountered.

Your profile

Required Education and Experience
  • Bachelor’s Degree (BA or BS)  
  • 3-4 years of experience of CSV experience in pharmaceutical industry or other related industry
  • Experience in an FDA regulated environment preferred

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 Irvine

Irvine is one of Siegfried’s sterile drug product manufacturing sites, providing contract development and manufacturing services (CDMO) specializing in difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices.

Main activities

  • Provides cGMP sterile drug product fill finish of biologics, suspensions, emulsions, ointments, and gels
  • All fully cGMP and SHE compliant

Features

  • Commercial Products: 5 automated filling lines, Commercial manufacturing, Batch sizes up to 150 K units, Fill Volumes 0.5 ml – 100 ml
  • Semi-automated and automated visual inspection
  • Automated packaging with digital data visual verification
  • Stability study services
  • Drug delivery
  • Laboratory services
  • Clinical Products small lot capability (semi-automated filling, batch sizes up to 5 K units)
  • Clinical manufacturing (batch sizes less than 5 K units)

Strategic importance

  • CDMO for innovative and difficult-to-manufacture products from clinical to commercial NDA and ANDA products
  • Provides contract sterile drug product manufacturing and laboratory services to the pharmaceutical and biotechnology industries