Quality Assurance Specialist
hace 18 horas
We are seeking a highly skilled Quality Assurance Specialist to join our team at Siegfried.
The successful candidate will be responsible for providing support to the QA Compliance and Systems department, ensuring the proper management and implementation of the Systems Master in compliance with product requirements.
This role involves maintaining and approving QA relevant data for raw materials, packaging materials, bulk, semi-finished and finished products in the SAP system of the Siegfried El Masnou plant.
Key responsibilities include:
- Maintaining and approving QA relevant data in SAP
- Mastering production formulations, developing, supervising and coordinating manufacturing phases
- QA approving product specifications for raw materials, materials and products in Labware System
- Requesting and approving change control related to Labware product specifications and item codes
- Reviewing and approving FUST protocols in Labware System
- Ensuring specifications are in accordance with product requirements
- Managing the current and historical Masters archive
Additional responsibilities include:
- Supporting QA Oversight in qualifications of new equipment and re-qualifications
- Reviewing and approving documentation related to qualification/re-qualification activities
- Managing deviations related to equipment
- Managing change control related to equipment
- Reviewing and approving CCDs of equipment performance checks in Labware System
- Reviewing and approving periodic requalification, reviews and re-evaluation of systems and equipment
- Supporting the Management of Risk Management and Change Control
- Reviewing and approving documentation associated with Deviations, CAPAs and Change Controls
- Reviewing and approving new versions of global policies related to Engineering/Validation department
- Ensuring continuous review and update of procedures applicable to the role
To be successful in this role, you will need:
- University degree in Pharmacy, Engineering, Chemistry or Microbiology
- Fluent English and Spanish
At Siegfried, we offer a dynamic and international work environment with a highly professional and motivated team.
We prioritize providing 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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