Ready to safeguard quality at the heart of aseptic manufacturing and make a real impact in a cutting‑edge pharmaceutical environment?
Proclinical is seeking a Quality Assurance Associate (Filling) to join a dynamic team in Switzerland. This role focuses on ensuring compliance and quality in aseptic manufacturing processes, including deviation management, risk assessment, and GMP adherence. The position offers a mix of office‑based responsibilities and on‑site activities in cleanroom environments. Flexibility to adapt to changing priorities and occasional work outside regular hours is required.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities
Manage deviations in aseptic filling and visual inspection processes, including conducting initial assessments and supporting investigation strategies.
Collaborate with operations teams to define corrective and preventive actions (CAPAs) and ensure compliance.
Review investigation reports in both German and English for compliance and risk assessment.
Support internal and external inspections by preparing and presenting deviation‑related documentation.
Provide guidance on aseptic manufacturing processes, ensuring GMP compliance without direct hands‑on production or lab activities.
Participate in projects such as commissioning new filling lines and implementing regulatory requirements.
Review and document aseptic production processes and support employee training and requalification.
Assist production teams throughout the manufacturing process, focusing on compliance and risk evaluation.
Key Skills and Requirements
Degree in natural sciences (Bachelor's, Master's, or PhD) or equivalent qualification.
Native German speaker with strong English proficiency (written and spoken).
Knowledge of GMP and pharmaceutical industry practices; experience in QA or aseptic areas is advantageous.
Strong analytical skills with the ability to critically assess and structure reports and texts.
Team‑oriented mindset with excellent communication and interpersonal skills.
Ability to manage multiple projects, adapt to changing circumstances, and meet strict deadlines.
Willingness to occasionally work outside regular office hours to observe production processes.
#J-18808-Ljbffr
Proclinical is seeking a Quality Assurance Associate (Filling) to join a dynamic team in Switzerland. This role focuses on ensuring compliance and quality in aseptic manufacturing processes, including deviation management, risk assessment, and GMP adherence. The position offers a mix of office‑based responsibilities and on‑site activities in cleanroom environments. Flexibility to adapt to changing priorities and occasional work outside regular hours is required.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities
Manage deviations in aseptic filling and visual inspection processes, including conducting initial assessments and supporting investigation strategies.
Collaborate with operations teams to define corrective and preventive actions (CAPAs) and ensure compliance.
Review investigation reports in both German and English for compliance and risk assessment.
Support internal and external inspections by preparing and presenting deviation‑related documentation.
Provide guidance on aseptic manufacturing processes, ensuring GMP compliance without direct hands‑on production or lab activities.
Participate in projects such as commissioning new filling lines and implementing regulatory requirements.
Review and document aseptic production processes and support employee training and requalification.
Assist production teams throughout the manufacturing process, focusing on compliance and risk evaluation.
Key Skills and Requirements
Degree in natural sciences (Bachelor's, Master's, or PhD) or equivalent qualification.
Native German speaker with strong English proficiency (written and spoken).
Knowledge of GMP and pharmaceutical industry practices; experience in QA or aseptic areas is advantageous.
Strong analytical skills with the ability to critically assess and structure reports and texts.
Team‑oriented mindset with excellent communication and interpersonal skills.
Ability to manage multiple projects, adapt to changing circumstances, and meet strict deadlines.
Willingness to occasionally work outside regular office hours to observe production processes.
#J-18808-Ljbffr
Quality Assurance Associate (Filling) Arbeitgeber: Proclinical Group
Proclinical ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, als Global Launch Manager in einer dynamischen und innovativen Umgebung in Zentraldeutschland zu arbeiten. Unsere Unternehmenskultur fördert Zusammenarbeit und Kreativität, während wir gleichzeitig auf individuelle Entwicklung und Wachstum unserer Mitarbeiter Wert legen. Genießen Sie attraktive Vorteile und die Chance, an globalen Strategien mitzuwirken, die den Erfolg unseres Unternehmens maßgeblich beeinflussen.
