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Quality Assurance Specialist
hace 2 meses
Job Title: QA Compliance and Systems Specialist
Job Summary:
We are seeking a highly skilled QA Compliance and Systems Specialist to join our team at Siegfried. The successful candidate will be responsible for ensuring the proper management and implementation of our Systems Master, ensuring compliance with product requirements.
Key Responsibilities:
- Maintain and approve QA relevant data for raw materials, packaging materials, bulk, semi-finished and finished products in the SAP system.
- Develop, supervise and coordinate the creation and flow of manufacturing phases, including bulk, filling and packaging.
- Approve product specifications for raw materials, materials and products in the Labware System.
- Request and approve change control related to Labware product specifications and item codes.
- Review and approve FUST protocols in the Labware System.
- Ensure all specifications are in accordance with product requirements.
- Responsible for the current and historical Masters archive.
Additional Responsibilities:
- Support QA Oversight in qualifications of new equipment and re-qualifications.
- Review and approve documentation related to qualification/re-qualification activities.
- Quality Responsible of deviations related to equipment.
- Quality Responsible of change control related to equipment.
- Review and approve CCDs of equipment performance checks in the Labware System.
Requirements:
- University degree in Pharmacy, Engineering, Chemistry or Microbiology.
- Fluent English and Spanish.
About Siegfried:
Siegfried is a leading Custom Development and Manufacturing Organization (CDMO) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. We integrate chemical and pharmaceutical capabilities into a single business model, offering a comprehensive range of services from Research & Development to commercial production.
Our Culture:
We value a dynamic and international work environment, with a highly professional and motivated team. Our unique culture leverages cultural differences to create a competitive advantage, providing a flexible, diverse and discrimination-free working environment where employees can develop personally and professionally.
