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Analytical compliance record specialist

Basel
Proclinical Group
Inserat online seit: 10 Juni
Beschreibung

PpEnsure cGMP excellence by safeguarding analytical compliance in a world‑class Swiss quality organization. /p pProclinical is seeking an Analytical Compliance Record Specialist to join a quality-focused team in Switzerland. This role involves working within a modern quality control organization to ensure compliance with cGMP regulations. You will play a key role in managing compliance records, facilitating root cause analyses, and supporting inspections. This is an exciting opportunity for individuals passionate about quality assurance in the pharmaceutical industry. /p pPlease note that to be considered for this role you must have the right to work in this location or hold an EU passport. /p h3Responsibilities /h3 ul liManage compliance records for the department, including deviations, changes, and CAPAs. /li liCollaborate with stakeholders such as QA, scientists, and senior management. /li liFacilitate and document root cause analyses. /li liActively participate in quality review boards and other strategic governing bodies. /li liSupport inspections by preparing and presenting records to internal and external auditors. /li liCritically evaluate work results to ensure high standards. /li liMaintain and enhance GMP compliance within the department. /li liDocument scientific and regulatory work accurately. /li /ul h3Key Skills and Requirements /h3 ul liA university degree (Bachelor's, Master's, or higher) in a relevant natural science field (e.g., Chemistry, Pharmacy, Biology). /li liAlternatively, candidates with a laboratory technician background and over 10 years of high-level GMP experience will be considered. /li li3-5 years of professional experience in a regulated pharmaceutical or biotech environment. /li liHands‑on experience working under cGMP regulations is mandatory. Proficiency in Quality Management Systems such as Veeva Vault or TrackWise. /li liDemonstrated ability to manage compliance records, including deviations, change control, and CAPAs. /li liBusiness fluency in English (written and spoken) for documentation and stakeholder management. /li liProficiency in German is a strong asset. /li /ul /p #J-18808-Ljbffr

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