Basel, Basel-City, Switzerland · On-site
<p>Wir sind ein junges, dynamisches Consulting-Unternehmen mit Fokus auf die Life-Science-Industrie und arbeiten täglich an hochwertigen, praxisnahen Lösungen für unsere Kundinnen und Kunden.</p> <p>Wir bieten fundiertes…
Skills: Quality Assurance, GMP Compliance, CQV, Risk Assessment, Deviation Management
Basel, Basel-City, Switzerland • On-site
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Responsible for QA oversight in GMP projects, including the planning and implementation of CQV strategies and the review of qualification documents. The role involves managing deviations, CAPAs, and changes while advising clients on compliance and quality requirements.
Requires a degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, Engineering, or similar, with at least 5 years of experience in a GMP-regulated environment. Proficiency in CQV, GMP guidelines (EU, FDA, ICH), and fluency in both German and English are essential.
Wir sind ein junges, dynamisches Consulting-Unternehmen mit Fokus auf die Life-Science-Industrie und arbeiten täglich an hochwertigen, praxisnahen Lösungen für unsere Kundinnen und Kunden.
Wir bieten fundiertes Engineering-Quality-Know-how für die Implementierung oder Verbesserung des gesamten technischen Qualitätskonzepts in der Life-Science-Industrie. Von Projekten und Erstfreigaben bis hin zu routinemäßigen Produktionsaufgaben beraten wir Kunden bei der Auswahl verschiedener Strategien und unterstützen diese dabei, ihre Ziele auf eine schlanke und konforme Weise zu erreichen. Unsere Dienstleistungen umfassen die Gestaltung und Umsetzung von Commisioning-, Qualifizierungs- und Validierungsstrategien, Durchführung von Risikobewertungen, Implementierung und Verbesserung von QM-Systemen sowie Vorbereitung und Teilnahme an Audits.
Wir suchen keine perfekten Lebensläufe, sondern engagierte Persönlichkeiten mit Leidenschaft, Eigeninitiative und dem Wunsch, gemeinsam etwas zu bewegen. Wenn du dich darin wiedererkennst, dann bewirb dich, wir sind gespannt auf dich.
Engineering Quality Consulting Services for the Life Science Industry
Consulting services for the life science industry We at Azimuth Quality offer you sound engineering quality know-how for the implementation or improvement of the entire technical quality concept, from projects and initial site releases to routine manufacturing and routinely recurring tasks. We advise you on the choice of different possible strategies and help you achieve your goals in a lean and compliant way, respecting your company culture and journey. Consultancy and Concepts -Design and implementation of lean, but compliant, Commissioning/ Qualification/ Validation Strategies (C&Q Master Plans & VMP’s, Policies, and SOPs as well as ongoing programs) - Risk Assessments (Qualification, Process, Contamination and Containment, Maintenance) -Gap Assessments (Compliance and Process) -QMS implementation and improvements -Engineering Quality, Maintenance and Calibration Strategies -Process Performance Qualification / Process Validation -Ongoing Process Verification Programs -Contamination Control Strategies -Disinfection Efficiency Studies -Sterility Expertise (Sterilization and Depyrogenation) -Product Changeover Monitoring -Environmental Monitoring -Audit Preparation & Participation Qualification and Validation Execution Equipment and Process for Biotechnology (upstream and downstream), Aseptic and Sterile Fill Finish Facilities, Solid Oral Dosage Forms, Liquids, Creams and Ointments, API manufacturing, blood-based products, and Live Biological Pharmaceuticals: -Cleanrooms, Isolators and BSC’s -Media and Gases -Equipment - Including Cycle Development, Riboflavin Testing, and Mapping -Computer System Validation -Cleaning Validation & Hold Time Studies -Requalification and Periodic Reviews
Offices: Grellingerstrasse 9, Basel, BS 4052, CH
Engineering Quality Consulting Services for the Life Science Industry
Consulting services for the life science industry We at Azimuth Quality offer you sound engineering quality know-how for the implementation or improvement of the entire technical quality concept, from projects and initial site releases to routine manufacturing and routinely recurring tasks. We advise you on the choice of different possible strategies and help you achieve your goals in a lean and compliant way, respecting your company culture and journey. Consultancy and Concepts -Design and implementation of lean, but compliant, Commissioning/ Qualification/ Validation Strategies (C&Q Master Plans & VMP’s, Policies, and SOPs as well as ongoing programs) - Risk Assessments (Qualification, Process, Contamination and Containment, Maintenance) -Gap Assessments (Compliance and Process) -QMS implementation and improvements -Engineering Quality, Maintenance and Calibration Strategies -Process Performance Qualification / Process Validation -Ongoing Process Verification Programs -Contamination Control Strategies -Disinfection Efficiency Studies -Sterility Expertise (Sterilization and Depyrogenation) -Product Changeover Monitoring -Environmental Monitoring -Audit Preparation & Participation Qualification and Validation Execution Equipment and Process for Biotechnology (upstream and downstream), Aseptic and Sterile Fill Finish Facilities, Solid Oral Dosage Forms, Liquids, Creams and Ointments, API manufacturing, blood-based products, and Live Biological Pharmaceuticals: -Cleanrooms, Isolators and BSC’s -Media and Gases -Equipment - Including Cycle Development, Riboflavin Testing, and Mapping -Computer System Validation -Cleaning Validation & Hold Time Studies -Requalification and Periodic Reviews
Offices: Grellingerstrasse 9, Basel, BS 4052, CH
