Quality Assurance Specialist

hace 4 semanas


El Masnou, Barcelona, España Siegfried A tiempo completo
Job Title: QA Compliance & Systems Specialist

About the Role:

We are seeking a highly skilled QA Compliance & Systems Specialist to join our team at Siegfried. As a key member of our quality assurance team, you will be responsible for ensuring the proper management and implementation of our Systems Master in compliance with product requirements.

Key Responsibilities:

  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.
  2. Maintains and approves QA relevant data for raw materials, packaging materials, bulk, semi-finished and finished products in SAP system of Siegfried El Masnou plant.
  3. Masters of production formulations: Develops, supervises and coordinates the creation and flow of the different manufacturing phases: bulk, filling and packaging (BOM's).
  4. QA approver of product specifications for raw materials, materials and products in Labware System.
  5. Requests and approves change control related to Labware product specifications and item codes.
  6. Reviews and approves FUST protocols in Labware System.
  7. Ensures that all specifications are in accordance with the product requirements.
  8. Responsible for the current and historical Masters archive.
  9. Gives support to QA Oversight in qualifications of new equipments and re-qualifications.
  10. Reviews and approves documentation related to the qualification/re-qualification activities (HLRA, URS, protocols, reports and SOPs).
  11. Quality Responsible of deviations related to equipments.
  12. Quality Responsible of change control related to equipments.
  13. Reviews and approves CCDs of equipment performance checks in Labware System.
  14. Reviews 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.
  15. Reviews and approval of periodic requalification, periodic reviews and re-evaluation of the systems and equipment.
  16. Gives support to the Management of Risk Management and Change Control.
  17. Reviews and approval of the documentation associated with Deviations, CAPAs management and Change Controls, where appropriate.
  18. Reviews and approval of new versions of global policies related to Engineering/Validation department.
  19. Assures the continuous review and update of procedures applicable to her activities.

About You:

We are looking for a highly motivated and detail-oriented individual with a strong background in quality assurance and systems compliance. You should have a university degree in Pharmacy, Engineering, Chemistry or Microbiology and be fluent in English and Spanish.

About Siegfried:

Siegfried is a leading Custom Development and Manufacturing Organization (CDMO) with a strong presence in Europe, Asia and North America. We offer a dynamic and international work environment with a highly professional and motivated team. Our company culture is built on a unique blend of cultural differences, which creates a competitive advantage. We strive to provide a flexible, diverse and discrimination-free working environment where employees can develop personally and professionally, advance innovation and deliver superior performance.



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