QA Engineer - Basel, Schweiz - Pharma Industrie
Firmenname für PREMIUM-Mitglieder sichtbar
- Mai 2024
- November 2024
- CH-Großraum Basel
- auf Anfrage
- 28.03.2024
Projekt Insights
Projektbeschreibung
Are you an experienced QA Engineer eager to take the next step in your career? An exciting opportunity has arisen with one of our esteemed Swiss-based clients. This role offers the chance to join a dedicated team focused on engaging Biopharmaceutical projects.
Responsibilities
• Hold responsibility for all quality-related tasks related to daily qualification activities for technical facilities, equipment, and systems.
• Assist in developing, reviewing, and approving qualification documents.
• Review and approve relevant qualification documents.
• Evaluate and approve change requests to ensure compliance with qualified state conditions and facilitate quality risk analysis.
• Ensure thorough investigation and resolution of deviations through deviation report processing.
• Ensure QA activities align with legislative, regulatory, and customer expectations.
• Keep the Group Manager QA Qualification informed about relevant developments and trends.
• Actively contribute to formulating and enhancing qualification strategies and undergo continuous training accordingly.
• Support internal audits as per the internal audit plan, participate in customer audits, and represent QA (SME) during official inspections.
Qualifications
• Bachelor's/Master's degree or its equivalent from a recognised university in a technical subject such as biological sciences, engineering, biotechnology, or quality assurance.
• 5 years or more of experience in the pharmaceutical industry, related GMP environment, or equivalent
• Proficient in QA Qualification processes
• Familiarity with FAT/SAT/IQ/OQ/PQ
• Fluency in English, both written and spoken, is essential
• Proficiency in German is highly preferred
Responsibilities
• Hold responsibility for all quality-related tasks related to daily qualification activities for technical facilities, equipment, and systems.
• Assist in developing, reviewing, and approving qualification documents.
• Review and approve relevant qualification documents.
• Evaluate and approve change requests to ensure compliance with qualified state conditions and facilitate quality risk analysis.
• Ensure thorough investigation and resolution of deviations through deviation report processing.
• Ensure QA activities align with legislative, regulatory, and customer expectations.
• Keep the Group Manager QA Qualification informed about relevant developments and trends.
• Actively contribute to formulating and enhancing qualification strategies and undergo continuous training accordingly.
• Support internal audits as per the internal audit plan, participate in customer audits, and represent QA (SME) during official inspections.
Qualifications
• Bachelor's/Master's degree or its equivalent from a recognised university in a technical subject such as biological sciences, engineering, biotechnology, or quality assurance.
• 5 years or more of experience in the pharmaceutical industry, related GMP environment, or equivalent
• Proficient in QA Qualification processes
• Familiarity with FAT/SAT/IQ/OQ/PQ
• Fluency in English, both written and spoken, is essential
• Proficiency in German is highly preferred
Kontaktdaten
Als registriertes Mitglied von freelance.de können Sie sich direkt auf dieses Projekt bewerben.
Ähnliche Projekte
Kategorien und Skills
Technik, Ingenieurwesen:
IT, Entwicklung:
Finanzen, Versicherung, Recht:
Sie suchen Freelancer?
Schreiben Sie Ihr Projekt aus und erhalten Sie noch heute passende Angebote.
Jetzt Projekt erstellen