Safeguard quality, ensure compliance, and make a measurable impact in life‑changing pharmaceuticals.
Proclinical is seeking a QA Associate to support quality assurance activities within the cardiovascular and pharmaceutical industry. In this role, you will focus on ensuring compliance with regulatory standards and maintaining high‑quality processes. This is an excellent opportunity for individuals passionate about quality control and looking to contribute to impactful projects in a dynamic environment.
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
Provide guidance and support for aseptic manufacturing and microbiological labs.
Ensure adherence to GMP standards in production processes.
Review and document work steps and processes in aseptic production.
Assist in training and requalification of production staff.
Address production issues related to compliance and risk assessment during manufacturing.
Manage deviations in aseptic filling, including initial assessments, investigation strategies, and corrective/preventive actions (CAPAs).
Review investigation reports in both German and English for compliance and risk evaluation.
Prepare deviation‑related documentation for internal and external inspections.
Support the review of procedural documents.
Key Skills and Requirements
Degree in a scientific field (Bachelor's, Master's, or PhD) or equivalent qualification.
Knowledge or experience in GMP or pharmaceutical industry is advantageous.
Strong analytical thinking and ability to structure and present logical conclusions clearly.
Proficiency in creating and reviewing technical texts and reports.
Team‑oriented mindset with excellent communication skills and assertiveness.
Ability to manage multiple projects and adapt to changing priorities.
High level of independence and initiative.
Native‑level German and strong English skills (written and spoken).
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