Austria Job Openings
Thermo Fisher Scientific
Quality Assurance Representative m/w/d Pharmazeutische Produktion
Linz
FULL TIME
October 24, 2024
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Ensure compliance with applicable c GMP guidelines (e.g., EU GMP Guide Part 2) during the development and production of intermediates and active pharmaceutical ingredients (APIs).
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Collaborate intensively with project management, production, chemical development, analytics, regulatory affairs, and other organizational units both on-site and across multiple sites.
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Provide customer support regarding quality-relevant issues, including project meetings, audits, quality agreements, customer questionnaires, change management, and complaints.
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Review and approve documents related to deviation and change management, validations, supplier qualification, and release of intermediates and active ingredients from a quality assurance perspective.
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Coordinate and support c GMP audits (internal and customer) and regulatory inspections.
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Enjoy working with people in a dynamic project environment.
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Co-design and further develop quality assurance systems within the framework of compliance projects.
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Completed natural science university or FH degree (chemistry, pharmacy, or similar).
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At least five years of professional experience.
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Experience in the field of c GMP/quality management.
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Experience in handling projects and/or regulatory affairs is an advantage.
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Distinctive process thinking, self-organization, and communication skills.
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Very good English skills and good MS Office skills.
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A workplace at an employer that encourages innovation and forward-thinking.
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Excellent development and career opportunities in a globally growing company.
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Attractive company pension scheme.
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A culture that values integrity, involvement, intensity, and innovation.
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