Direct message the job poster from Proclinical Staffing
Senior Research Associate @ Proclinical Staffing - DACH | Life Sciences Engineering & Manufacturing
Looking for a role where quality isn't just a checkbox but a mission? Join our client as a QA Specialist and elevate your career in a dynamic CMO environment.
Proclinical is seeking a QA Specialist to act as a key quality assurance contact, ensuring compliance and supporting manufacturing operations. This position focuses on quality oversight, regulatory compliance, and continuous improvement initiatives.
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
* Represent QA in project teams and meetings, serving as the primary contact for quality-related topics.
* Address drug product QA-related questions, topics, and customer complaints tied to manufacturing operations.
* Support and approve risk assessments, including regulatory-specific risks or gap analyses.
* Review and release product-specific documentation such as process descriptions, workflows, manufacturing protocols, transfer documents, test plans, and parameter lists.
* Represent drug product QA during regulatory inspections.
* Contribute to continuous improvement programs to enhance the Quality Management System.
* Collaborate with cross-functional teams, including manufacturing, QC, support functions, and engineering, to ensure effective execution of drug product processes.
* Assess, review, and approve quality records and release files, including deviations, change controls, CAPAs, investigations, effectiveness checks, complaints, and APR/PQRs, in line with local SOPs.
Key Skills and Requirements
* Degree in Chemistry, Biology, Biotechnology, or a related field.
* Experience working in a GMP-regulated pharmaceutical environment.
* Background in quality assurance, particularly in drug product QA.
* Proficiency in English; German language skills are advantageous.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
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