Country Spain
City El Masnou
Functional Area Siegfried Group
Job Group Support Function
Employment Type Defined contract (Siegfried)
Defined Contract Period 6 months
Working time Full-time
Country Spain
City El Masnou
Functional Area Siegfried Group
Job Group Support Function
Employment Type Defined contract (Siegfried)
Defined Contract Period 6 months
Working time Full-time
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
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